Retina Pipeline? What's in the - Retina Today

Page created by Antonio Norman
 
CONTINUE READING
Retina Pipeline? What's in the - Retina Today
NOV/DEC 2020 VOL. 15, NO. 8 | RETINATODAY.COM

                      What’s in the
            Retina Pipeline?
                           Tracking the
                           treatments
                           of tomorrow.

         THE LATEST FINDINGS FROM     A LOOK AT FUTURE THERAPEUTICS   THE PROMISE OF SUSTAINED-RELEASE
         AMD TREATMENT TRIALS         FOR DIABETIC RETINOPATHY        POLYMER TECHNOLOGIES

1120RT_cover.indd 1                                                                                      12/4/20 3:43 PM
Retina Pipeline? What's in the - Retina Today
This is

        Laser-ablated micro-surface is designed to support
        atraumatic ILM peel initiation1

        Optimized grasping platform and angled tip closure
        to help mitigate membrane shredding2

        GRIESHABER® DSP IMPORTANT PRODUCT INFORMATION
        Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Indications for Use: GRIESHABER® DSP instruments are a line of single-use
        vitreoretinal microinstruments which are used in ophthalmic surgery, for cases either in the anterior or the posterior segment. The GRIESHABER® Advanced Backflush Handles
        DSP are a family of instruments for fluid and gas handling in vitreoretinal surgery. Warnings and Precautions: • Potential risk from reuse or reprocessing GRIESHABER® DSP
        instruments include: foreign particle introduction to the eye; reduced cutting or grasping performance; path leaks or obstruction resulting in reduced fluidics performance.
        • Verify correct tip attachment, function and tip actuation before placing it into the eye for surgery. • For light fiber instruments: Minimize light intensity and duration of
        exposure to the retina to reduce risk of retinal photic injury. The light fiber instruments are designed for use with an ALCON® illumination source. • Good clinical practice
        dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. If stream of fluid is weak or absent, good fluidics response will be jeopardized. • Use
        appropriate pressure supply to ensure a stable IOP. • If unwanted tissue gets engaged to the aspiration port, it should be released by interrupting aspiration before moving
        the instrument. Attention: Please refer to the product labeling for a complete listing of indications, warnings, and precautions.

        Reference: 1. Data on File. Alcon Laboratories Inc; May 2018. 2. Data on File. Alcon Laboratories Inc; September 2017.

        © 2018 Novartis         5/18      US-GUS-18-E-1175

US-GUS-18-E-1175 RT.indd 1                                                                                                                                                            1/8/20 10:05 AM
Retina Pipeline? What's in the - Retina Today
This is

          Designed to:
                   Enhance stability with a continuously open port and
                   CONSTELLATION® Vision System’s IOP compensation1
                   Reduce pulsatile traction with 20 000 cuts per minute
                   using 25+® and 27+® gauge probes*, 2,3
                   Improve vitreous flow4
                   Enable closer access to tissue plane with beveled tip5

        *At similar single-blade flow rates

        MIVS IMPORTANT PRODUCT INFORMATION
        Caution: Federal law restricts this device to sale by, or on the order of, a physician. Indications for Use: The CONSTELLATION® Vision System is an ophthalmic microsurgical system that is indicated for both anterior segment (i.e., phacoemulsification and removal of
        cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. The ULTRAVIT® Vitrectomy Probe is indicated for vitreous cutting and aspiration, membrane cutting and aspiration, dissection of tissue and lens removal. The valved entry system is indicated for
        scleral incision, canulae for posterior instrument access and venting of valved cannulae. The infusion cannula is indicated for posterior segment infusion of liquid or gas. Warnings and Precautions: • The infusion cannula is contraindicated for use of oil infusion. • Attach
        only Alcon supplied products to console and cassette luer fittings. Improper usage or assembly could result in a potentially hazardous condition for the patient. Mismatch of surgical components and use of settings not specifically adjusted for a particular combination of
        surgical components may affect system performance and create a patient hazard. Do not connect surgical components to the patient’s intravenous connections. • Each surgical equipment/component combination may require specific surgical setting adjustments. Ensure
        that appropriate system settings are used with each product combination. Prior to initial use, contact your Alcon sales representative for in-service information. • Care should be taken when inserting sharp instruments through the valve of the Valved Trocar Cannula.
        Cutting instrument such as vitreous cutters should not be actuated during insertion or removal to avoid cutting the valve membrane. Use the Valved Cannula Vent to vent fluids or gases as needed during injection of viscous oils or heavy liquids. • Visually confirm that
        adequate air and liquid infusion flow occurs prior to attachment of infusion cannula to the eye. • Ensure proper placement of trocar cannulas to prevent sub-retinal infusion. • Leaking sclerotomies may lead to post operative hypotony. • Vitreous traction has been known to
        create retinal tears and retinal detachments. • Minimize light intensity and duration of exposure to the retina to reduce the risk of retinal photic injury. ATTENTION: Please refer to the CONSTELLATION® Vision System Operators Manual for a complete listing of indications,
        warnings and precautions.

        References: 1. Irannejad A, Tambat S, Abulon DJK. Retropulsion and mass flow of 27-gauge vitrectomy probes: comparison of dual-blade/flat-tipped probes and single-blade/beveled probes. Poster presented at: 18th Congress of the European Society of Retina
        Specialists; September 20–23, 2018; Vienna, Austria. 2. Alcon data on file. Alcon Laboratories, Inc; June 2018. 3. Alcon data on file. Alcon Laboratories, Inc; June 2018. 4. Alcon data on file. Alcon Laboratories, Inc; June 2018. 5. Alcon data on file. Alcon Laboratories,
        Inc; May 2017.

        ©2019 Alcon             5/19       US-GAU-19-E-0842

US-GAU-19-E-0842 RT.indd 1                                                                                                                                                                                                                                                         1/8/20 10:05 AM
Retina Pipeline? What's in the - Retina Today
EDITORIAL ADVISORY BOARD
                      CHIEF MEDICAL                                    ASSOCIATE
                                                                                                                   Thomas Albini                               Pravin U. Dugel                             John W. Kitchens                             Elias Reichel
                      EDITOR                                           MEDICAL EDITOR                              Miami, FL                                   Phoenix, AZ                                 Lexington, KY                                Boston, MA
                     Allen C. Ho                                      Robert L. Avery                              J. Fernando Arevalo                         Jay S. Duker                                Derek Y. Kunimoto                            Carl D. Regillo
                     Philadelphia, PA                                 Santa Barbara, CA                            Baltimore, MD                               Boston, MA                                  Phoenix, AZ                                  Philadelphia, PA
                                                                                                                   Carl C. Awh                                 Jorge Fortun                                Baruch Kuppermann                            Kourous A. Rezaei
                                                                                                                   Nashville, TN                               Miami, FL                                   Irvine, CA                                   Chicago, IL
                      SECTION EDITORS                                                                              G. William Aylward                          Thomas R. Friberg                           Rohit Ross Lakhanpal                         Philip J. Rosenfeld
                     RETINA PEARLS                                  GLOBAL PERSPECTIVES                            London, UK                                  Pittsburgh, PA                              Owings Mills, MD                             Miami, FL
                     Dean Eliott                                    Albert J. Augustin                             Caroline R. Baumal                          Julia A. Haller                             Theodore Leng                                Steven D. Schwartz
                     Boston, MA                                     Karlsruhe, Germany                             Boston, MA                                  Philadelphia, PA                            Palo Alto, CA                                Los Angeles, CA
                     Ingrid U. Scott                                Ehab El Rayes                                  Rubens Belfort Jr.                          Tarek S. Hassan                             Xiaoxin Li                                   Carol L. Shields
                     Hershey, PA                                    Cairo, Egypt                                   São Paulo, Brazil                           Royal Oak, MI                               Beijing, China                               Philadelphia, PA
                                                                                                                   Audina M. Berrocal                          Jeffrey Heier                               Jordi M. Mones
                                                                    Stanislao Rizzo                                Miami, FL                                                                                                                            Richard F. Spaide
                     BUSINESS MATTERS                                                                                                                          Boston, MA                                  Barcelona, Spain                             New York, NY
                     Alan Ruby                                      Florence, Italy                                María H. Berrocal
                                                                                                                   San Juan, Puerto Rico                       S.K. Steven Houston III                     Andrew A. Moshfeghi                          Ramin Tadayoni
                     Royal Oak, MI                                  Lihteh Wu                                                                                  Lake Mary, FL                               Los Angeles, CA
                                                                                                                   David M. Brown                                                                                                                       Paris, France
                                                                    San José, Costa Rica                                                                       Jason Hsu                                   Timothy G. Murray                            Sjakon George Tahija
                     MEDICAL RETINA                                                                                Houston, TX
                     Jordana G. Fein                                FELLOWS’ FOCUS                                 David S. Boyer                              Philadelphia, PA                            Miami, FL                                    Jakarta, Indonesia
                     Fairfax, VA                                    Michael J. Ammar                               Los Angeles, CA                             Michael Ip                                  Anton Orlin                                  Nadia Waheed
                                                                    Philadelphia, PA                               Robison V. Paul Chan                        Los Angeles, CA                             New York, NJ                                 Boston, MA
                     Heeral R. Shah                                                                                                                            Glenn J. Jaffe                              Yusuke Oshima
                                                                                                                   Chicago, IL                                                                                                                          George A. Williams
                     Joplin, MO                                     Luv Patel                                                                                  Durham, NC                                  Osaka, Japan                                 Royal Oak, MI
                                                                                                                   Steve Charles
                     EYETUBE RETINA CHIEF
                                                                    Philadelphia, PA                               Memphis, TN                                 Kazuaki Kadonosono                          Kirk H. Packo                                Charles C. Wykoff
                     Michael A. Klufas                              Matthew R. Starr                               Allen Chiang                                Yokohama City, Japan                        Chicago, IL                                  Houston, TX
                     Philadelphia, PA                               Philadelphia, PA                               Philadelphia, PA                            Peter K. Kaiser                             Jonathan L. Prenner                          Young Hee Yoon
                                                                                                                   David R. Chow                               Cleveland, OH                               New Brunswick, NJ                            Seoul, South Korea
                                                                    VISUALLY SPEAKING                              Mississauga, Canada                         Richard S. Kaiser                           Aleksandra Rachitskaya
                                                                    Manish Nagpal                                  Kim Drenser                                 Philadelphia, PA                            Cleveland, OH
                                                                    Gujarat, India                                 Royal Oak, MI                               Szilárd Kiss                                Ehsan Rahimy
                                                                                                                                                               New York, NY                                Palo Alto, CA
                    BUSINESS                                                                          David Levine, Executive Vice President,                                             Stephen Daily, Executive Editor, News
                                                                                                      Digital & Custom Media                                                              +1 484 581 1871; sdaily@bmctoday.com
                  David Cox, President/Cofounder                                                      +1 609 933 6799; dlevine@bmctoday.com
                  +1 484 581 1814; dcox@bmctoday.com                                                                                                                                      Cara Deming, Director, Special Projects
                                                                                                      Laura O’Connor, Director,                                                           +1 484 581 1889; cdeming@bmctoday.com
                  Adam Krafczek Jr, Esq, Cofounder                                                    Market Analysis & Strategy
                  +1 484 581 1815; adam@bmctoday.com                                                  +1 484 581 1860; loconnor@bmctoday.com
                  Tamara Bogetti, MBA                                                                                                                                                       ART/PRODUCTION
                                                                                                      Alvin Fu, Senior Director, Analytics & Technology
                  Executive Vice President/Group Publisher                                            +1 484 581 1888; afu@bmctoday.com                                                   John Follo, Creative/Production Director
                  +1 714 878 0568; tbogetti@bmctoday.com                                                                                                                                  +1 484 581 1811; jfollo@bmctoday.com
                  Janet Burk, Publisher                                                                                                                                                   Dominic Condo, Art/Production Director
                  +1 214 394 3551; jburk@bmctoday.com                                                   EDITORIAL                                                                         +1 484 581 1834; dcondo@bmctoday.com
                  Gaynor Morrison,                                                                    Rebecca Hepp, Editor-in-Chief                                                       Joe Benincasa, Digital Art Director
                  Vice President, Sales                                                               +1 484 581 1880; rhepp@bmctoday.com                                                 +1 484 581 1822; jbenincasa@bmctoday.com
                  +1 484 581 1836; gaynor@bmctoday.com                                                Katie Herman, Associate Editor                                                      Rachel McHugh, Associate Art Director
                  Barbara Bandomir, Vice President, Operations                                        +1 484 581 1897; kherman@bmctoday.com                                               +1 484 581 1853; rmchugh@bmctoday.com
                  +1 484 581 1810; bbandomir@bmctoday.com                                             Tim Donald, ELS, Consulting Editor
                  Camela Pastorius, CMP, Vice President,                                              tdonald@bmctoday.com
                  Meetings & Events,                                                                  Gillian McDermott, MA, Editor-in-Chief, Clinical
                  Bryn Mawr Communications Group                                                      Content, Anterior Segment
                  +1 484 581 1807; cpastorius@bmctoday.com                                            +1 484 581 1812; gmcdermott@bmctoday.com
                Retina Today (ISSN 1942-1257) © 2020 Bryn Mawr Communications LLC is published January/February, March, April, May/June, July/August, September, October, and November/December by Bryn Mawr Communications LLC,
                1008 Upper Gulph Road, Wayne, PA 19087. Subscription is free to all applicable US retina physicians. All others, applicable subscription charges apply. For subscription information call +1 800 492 1267 (US only) or e-mail
                retinatoday@bmctoday.com. Pending periodical postage paid at Wayne PA and additional entry offices. POSTMASTER Please send address changes to Bryn Mawr Communications LLC, 1008 Upper Gulph Road, Wayne, PA 19087. Bryn Mawr
                Communications LLC provides certain customer contact data, which may include customer names, addresses, phone numbers and e-mail addresses, to third parties for promotional and/or marketing purposes. If you do not wish Bryn Mawr Communications
                LLC to make your contact information available to third parties for any marketing purposes, please contact us at 800-492-1267 or e-mail us at retinatoday@bmctoday.com. This publication is intended for health care professionals and providers only. The
                information contained in this publication, including text, graphics and images, is for informational purposes only and is not intended to be a substitute for professional medical advice. Bryn Mawr Communications LLC, via its Editors and the Publisher,
                accepts no responsibility for any injury or damage to persons or property occasioned through the implementation of any ideas or use of any product described herein. While great care is taken by the Publisher and Editors to ensure that all information
                is accurate, it is recommended that readers seek independent verification of advice on drug or other product usage, surgical techniques and clinical processes prior to their use. The opinions expressed in this publication are those of the authors and are
                not attributable to the sponsors, the publication or the Editorial Board. References made in articles may indicate uses of medical equipment or drugs at dosages, for periods of time and in combinations not included in the current prescribing informa-
                tion. Inclusion of advertising material in this publication, or in supplements thereof, does not constitute any representation or guarantee by Bryn Mawr Communications LLC of the quality of such products or of the claims made by the manufacturers.
                © 2020 Bryn Mawr Communications LLC. All Rights Reserved. Reproduction in whole or in part without permission is strictly prohibited.

          4 RETINA TODAY | NOVEMBER/DECEMBER 2020

1120RT_Edboard/Staff.indd 4                                                                                                                                                                                                                                                      12/4/20 3:45 PM
Retina Pipeline? What's in the - Retina Today
Discover continuous
calm in uveitis
YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg:
  • Proven to reduce uveitis recurrence at 6 and 12 months1*
     [At 6 months–18% for YUTIQ and 79% for sham for study 1 and 22% for YUTIQ and 54% for sham for study 2 (P
Retina Pipeline? What's in the - Retina Today
YUTIQ™ (fluocinolone acetonide intravitreal implant) 0.18 mg,                               Table 1:     Ocular Adverse Reactions Reported in ≥ 1% of Subject Eyes and
for intravitreal injection                                                                               Non-Ocular Adverse Reactions Reported in ≥ 2% of Patients
Initial U.S. Approval: 1963
                                                                                                                               Ocular
BRIEF SUMMARY: Please see package insert for full prescribing information.
                                                                                                                                     YUTIQ           Sham Injection
1. INDICATIONS AND USAGE. YUTIQ™ (fluocinolone acetonide intravitreal
implant) 0.18 mg is indicated for the treatment of chronic non-infectious uveitis                 ADVERSE REACTIONS               (N=226 Eyes)         (N=94 Eyes)
affecting the posterior segment of the eye.                                                                                           n (%)               n (%)
4. CONTRAINDICATIONS. 4.1. Ocular or Periocular Infections. YUTIQ is contra-                  Vitreous Hemorrhage                    4 ( 2%)                 0
indicated in patients with active or suspected ocular or periocular infections includ-        Iridocyclitis                          3 ( 1%)              7 ( 7%)
ing most viral disease of the cornea and conjunctiva including active epithelial
herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infec-     Eye Inflammation                       3 ( 1%)              2 ( 2%)
tions and fungal diseases. 4.2. Hypersensitivity. YUTIQ is contraindicated in                 Choroiditis                            3 ( 1%)              1 ( 1%)
patients with known hypersensitivity to any components of this product.
                                                                                              Eye Irritation                         3 ( 1%)              1 ( 1%)
5. WARNINGS AND PRECAUTIONS. 5.1. Intravitreal Injection-related Effects.
Intravitreal injections, including those with YUTIQ, have been associated with                Visual Field Defect                    3 ( 1%)                 0
endophthalmitis, eye inflammation, increased or decreased intraocular pressure,               Lacrimation Increased                  3 ( 1%)                 0
and choroidal or retinal detachments. Hypotony has been observed within 24 hours
of injection and has resolved within 2 weeks. Patients should be monitored follow-                                           Non-ocular
ing the intravitreal injection [see Patient Counseling Information (17) in the full                                                  YUTIQ           Sham Injection
prescribing information]. 5.2. Steroid-related Effects. Use of corticosteroids                     ADVERSE REACTIONS            (N=214 Patients)     (N=94 Patients)
including YUTIQ may produce posterior subcapsular cataracts, increased intraocu-                                                      n (%)               n (%)
lar pressure and glaucoma. Use of corticosteroids may enhance the establishment
of secondary ocular infections due to bacteria, fungi, or viruses. Corticosteroids are        Nasopharyngitis                       10 ( 5%)             5 ( 5%)
not recommended to be used in patients with a history of ocular herpes simplex                Hypertension                           6 ( 3%)             1 ( 1%)
because of the potential for reactivation of the viral infection. 5.3. Risk of Implant        Arthralgia                             5 ( 2%)             1 ( 1%)
Migration. Patients in whom the posterior capsule of the lens is absent or has a
tear are at risk of implant migration into the anterior chamber.                            1. Includes cataract, cataract subcapsular and lenticular opacities in study eyes
6. ADVERSE REACTIONS. 6.1. Clinical Studies Experience. Because clinical trials                that were phakic at baseline. 113 of the 226 YUTIQ study eyes were phakic at
are conducted under widely varying conditions, adverse reaction rates observed in              baseline; 56 of 94 sham-controlled study eyes were phakic at baseline.
the clinical trials of a drug cannot be directly compared to rates in the clinical trials
of another drug and may not reflect the rates observed in practice. Adverse reac-           Table 2:   Summary of Elevated IOP Related Adverse Reactions
tions associated with ophthalmic steroids including YUTIQ include cataract forma-                                                YUTIQ                 Sham
tion and subsequent cataract surgery, elevated intraocular pressure, which may be                ADVERSE REACTIONS            (N=226 Eyes)          (N=94 Eyes)
associated with optic nerve damage, visual acuity and field defects, secondary ocu-                                               n (%)                 n (%)
lar infection from pathogens including herpes simplex, and perforation of the globe
where there is thinning of the cornea or sclera. Studies 1 and 2 were multicenter,             IOP elevation ≥ 10 mmHg
                                                                                                                                50 (22%)              11 (12%)
randomized, sham injection-controlled, masked trials in which patients with non-                     from Baseline
infectious uveitis affecting the posterior segment of the eye were treated once with           IOP elevation > 30 mmHg          28 (12%)               3 (3%)
either YUTIQ or sham injection, and then received standard care for the duration of
the study. Study 3 was a multicenter, randomized, masked trial in which patients              Any IOP-lowering medication       98 (43%)              39 (41%)
with non-infectious uveitis affecting the posterior segment of the eye were all                 Any surgical intervention
treated once with YUTIQ, administered by one of two different applicators, and then                                              5 (2%)                2 (2%)
                                                                                                    for elevated IOP
received standard care for the duration of the study. Table 1 summarizes data avail-
able from studies 1, 2 and 3 through 12 months for study eyes treated with YUTIQ                                  Figure 1: Mean IOP During the Studies
(n=226) or sham injection (n=94). The most common ocular (study eye) and non-
ocular adverse reactions are shown in Table 1 and Table 2.
Table 1: Ocular Adverse Reactions Reported in ≥ 1% of Subject Eyes and
              Non-Ocular Adverse Reactions Reported in ≥ 2% of Patients
                                          Ocular
                                                YUTIQ               Sham Injection
       ADVERSE REACTIONS                    (N=226 Eyes)              (N=94 Eyes)
                                                 n (%)                    n (%)
   Cataract1                                63/113 (56%)             13/56 (23%)
   Visual Acuity Reduced                      33 ( 15%)                 11 (12%)
   Macular Edema                              25 ( 11%)                 33 (35%)
   Uveitis                                    22 ( 10%)                 33 (35%)
   Conjunctival Hemorrhage                     17 ( 8%)                   5 ( 5%)
   Eye Pain                                    17 ( 8%)                 12 (13%)            8. USE IN SPECIFIC POPULATIONS. 8.1 Pregnancy. Risk Summary. Adequate and
                                                                                            well-controlled studies with YUTIQ have not been conducted in pregnant women to
   Hypotony Of Eye                             16 ( 7%)                  1 ( 1%)            inform drug associated risk. Animal reproduction studies have not been conducted
   Anterior Chamber Inflammation               12 ( 5%)                  6 ( 6%)            with YUTIQ. It is not known whether YUTIQ can cause fetal harm when administered
                                                                                            to a pregnant woman or can affect reproduction capacity. Corticosteroids have been
   Dry Eye                                     10 ( 4%)                  3 ( 3%)            shown to be teratogenic in laboratory animals when administered systemically at
   Vitreous Opacities                           9 ( 4%)                  8 ( 9%)            relatively low dosage levels. YUTIQ should be given to a pregnant woman only if the
   Conjunctivitis                               9 ( 4%)                  5 ( 5%)            potential benefit justifies the potential risk to the fetus. All pregnancies have a risk of
                                                                                            birth defect, loss, or other adverse outcomes. In the United States general population,
   Posterior Capsule Opacification              8 ( 4%)                  3 ( 3%)            the estimated background risk of major birth defects and miscarriage in clinically rec-
   Ocular Hyperemia                             8 ( 4%)                  7 ( 7%)            ognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation. Risk
                                                                                            Summary. Systemically administered corticosteroids are present in human milk and
   Vitreous Haze                                7 ( 3%)                  4 ( 4%)            can suppress growth, interfere with endogenous corticosteroid production. Clinical or
   Foreign Body Sensation In Eyes               7 ( 3%)                  2 ( 2%)            nonclinical lactation studies have not been conducted with YUTIQ. It is not known
   Vitritis                                     6 ( 3%)                  8 ( 9%)            whether intravitreal treatment with YUTIQ could result in sufficient systemic absorp-
                                                                                            tion to produce detectable quantities of fluocinolone acetonide in human milk, or
   Vitreous Floaters                            6 ( 3%)                  5 ( 5%)            affect breastfed infants or milk production. The developmental and health benefits of
   Eye Pruritus                                 6 ( 3%)                  5 ( 5%)            breastfeeding should be considered, along with the mother’s clinical need for YUTIQ
                                                                                            and any potential adverse effects on the breastfed child from YUTIQ. 8.4 Pediatric
   Conjunctival Hyperemia                       5 ( 2%)                  2 ( 2%)            Use. Safety and effectiveness of YUTIQ in pediatric patients have not been estab-
   Ocular Discomfort                            5 ( 2%)                  1 ( 1%)            lished. 8.5 Geriatric Use. No overall differences in safety or effectiveness have been
   Macular Fibrosis                             5 ( 2%)                  2 ( 2%)            observed between elderly and younger patients.
   Glaucoma                                     4 ( 2%)                  1 ( 1%)
                                                                                            Manufactured by:
   Photopsia                                    4 ( 2%)                  2 ( 2%)            EyePoint Pharmaceuticals US, Inc., 480 Pleasant Street, Watertown, MA 02472 USA
                                                                              (continued)   Patented.
Retina Pipeline? What's in the - Retina Today
MEDICAL EDITORS’ PAGE

                                                                                                                                                                s
                     RECALIBRATING …

                     A
                             s we write this editorial for the last issue of Retina       In addition, this issue contains ongoing Aspen Retinal
                             Today for 2020, we can’t help but look back on the        Detachment Society coverage; a thought-provoking article
                             unprecedented year we’ve all experienced. It started      on the importance of long-term inflammation control for
                             out like any other year: we were traveling to meet-       patients with uveitis by Robert C. Wang, MD; a fascinating
                             ings, booking surgeries, accepting invitations to         case of an extramacular dome-shaped elevation referred
                     lecture, writing our editorial for the January/February issue,    for suspicion of circumscribed choroidal hemangioma; an
                     and offering input on topics and authors as we planned for        exploration of how to build networks to screen for retinal
                     the March issue. By the time we began putting together            disease in underserved areas; and an article by a group of
                     our April issue, the novel coronavirus had fully made itself      doctors from Portugal who discuss how OCT angiography
                     known, and from then until our September issue we dedi-           can reveal early changes in hydroxychloroquine therapy.
                     cated much of each issue to topics related to both retina            Also, be sure to take in the beauty of the images in this
                     and COVID-19.                                                     issue’s Visually Speaking column on page 56, where Sham
                        The pandemic is far from over—we all know that. We             Talati, MBBS, DO; Manish Nagpal, MBBS, MS, FRCS; and
                     also know that a vaccine seems to be on the horizon, but          Navneet Mehrotra, MBBS, DNB, FRF, share the case of a
                     as retina specialists we can’t help with that. So we’ll let the   patient with a choroidal mass. We’ve also brought back
                     epidemiologists and scientists diligently work on that. In        our 5Q column, and in this issue you’ll get to know more
                     the meantime, we will do what we do best and cover time-          about Retina Today contributor Brian C. Joondeph, MD,
                     ly topics, including COVID-19, in Retina Today.                   MPS, FACS.
                        In this issue, we take a look at the retina pipeline,             As we close the book on 2020, we wish you all good
                     specifically early phase 1 and 2 studies exploring novel          health and happiness, and we look forward to seeing you
                     targets in the treatment of diabetic macular edema and            in 2021! n
                     AMD, later-stage trials for AMD, therapeutics for diabetic
                     retinopathy, and extended-release polymer technologies.
                     There are so many new agents, modalities, and technolo-
                     gies in clinical trials for the various conditions we treat,
                     it’s a refreshing reminder of the positive things happening        ALLEN C. HO, MD               ROBERT L. AVERY, MD
                     in the world.                                                      CHIEF MEDICAL EDITOR          ASSOCIATE MEDICAL EDITOR

                                                                                                                      NOVEMBER/DECEMBER 2020 | RETINA TODAY 7

1120RT_Editorial.indd 7                                                                                                                                   12/4/20 3:46 PM
Retina Pipeline? What's in the - Retina Today
TABLE OF CONTENTS

                                                                                                                                                  Cover image credit: ©iStockphoto.com

                    What’s in the Retina Pipeline?
                    26 M
                        acular Research on the Move                                             34 T he AMD Pipeline: A Look at the Latest Results
                       By Fuad Makkouk, MD; Brian B. Berger, MD; and Grace Andres                     By Nika Bagherhi, MD; Allen Chiang, MD; Robert L. Avery, MD;
                                                                                                      and Allen C. Ho, MD
                    30 A Timely Debut for Extended-Release Polymer Technologies                 38 The Future Looks Bright: The Therapeutics Pipeline
                        By Michael Weaver, MS; Tremayne Koochin, BKIN; and Heeral Shah, MD;            for Diabetic Retinopathy
                        Edited by Jordana G. Fein, MD                                                  By John Hinkle, MD, and Jason Hsu, MD

                    DEPARTMENTS
                     UP FRONTI                                                                     46 O CT Angiography Reveals Early Changes
                    7 Medical Editors’ Page                                                         With Hydroxychloroquine Therapy
                    10 Retina News                                                                  By Diogo Lopes, MD; Tomás Loureiro, MD; Ana Rita Carreira, MD;
                                                                                                      Ana Miranda, MD; Mafalda Pereira, MD; Inês Machado, MD; and
                                                                                                      Nuno Campos, MD
                     MEETING MINUTESI
                    12 A RDS: Presentation by Philip J. Ferrone, MD
                                                                                                    SPECIAL REPORTSI
                       Summarized by Abdallah Mahrous, MD
                                                                                                   50 O phthalmic Presentations of Pituitary Adenoma
                                                                                                       By Hanne Gehling, BS, and Kimberly M. Winges, MS
                     IMAGINGI
                    14 D ouble Trouble: A Tale of Two Intraocular Foreign Bodies
                                                                                                   53 T he Winning Pitch Challenge:
                       By Remya Mareen Paulose DNB, FLVPEI, FICO, FAICO, and
                                                                                                       Helping Innovators in the Trenches
                       Thomas Cherian, MS, FLVPEI
                                                                                                       By Daniel Chao, MD, PhD

                     MEDICAL RETINAI
                                                                                                    VISUALLY SPEAKINGI
                    16 L ong-Term Inflammation Control Benefits All Types of Uveitis
                                                                                                   56 C horoidal Mass: Wading Through the Differentials
                       By Robert C. Wang, MD
                                                                                                       By Sham Talati, MBBS, DO; Manish Nagpal, MBBS, MS, FRCS; and
                                                                                                       Navneet Mehrotra, MBBS, DNB, FRF
                     OCULAR ONCOLOGYI
                    18 A Masquerader of Circumscribed Chroidal Hemangioma                         IN THE BACKI
                       By Ahmed Sheikh, MD; Philip W. Dockery, MD, MPH; and Carol L. Shields, MD
                                                                                                   57 Ad Index
                                                                                                   58 5Q with Brian C. Joondeph, MD, MPS
                     GLOBAL PERSPECTIVESI
                    43 L aying Foundations for International Retina Care
                        An interview with Eric D. Hansen, MD, and Christopher B. Komanski, MD;
                        By Benjamin J. Thomas, MD

         8 RETINA TODAY | NOVEMBER/DECEMBER 2020

1120RT_TOC.indd 8                                                                                                                                                                12/4/20 3:51 PM
Retina Pipeline? What's in the - Retina Today
FDA-approved TissueBlue is Ready for You.                             ™

                                                Introducing

                                                 The ONLY FDA-approved selective stain for the ILM.
                                                 Easy open-and-inject application from a pre-filled,
                                                 sterile syringe.

CONFIDENCE OF SUPERIOR PURITY1 — FDA-approved, pharmaceutical-grade dye.
CONSISTENCY & CONVENIENCE — Pre-filled, sterile syringe eliminates need
to mix or source via compounding pharmacies.
PROVEN SAFETY* — Trusted for ILM staining in over 350,0002
procedures worldwide.

Confidence. Consistency. Convenience.

Visit tissueblue.com to learn more, request a sample†,
and receive further updates.
* Marketed as ILM Blue Outside US since 2010.
† Sample available to registered US physicians only. Samples subject to availability.
References
1. Data on file – Results of HPLC purity tests performed on samples of
compounded BBG dyes available in the U.S. 2. Total DORC Global Sales data
for ILM Blue since launch – available on file.

IMPORTANT INFORMATION ABOUT TISSUEBLUE™                                                 Ask your patient about all the medicines they take, including prescription and over-
(Brilliant Blue G Ophthalmic Solution) 0.025%                                           the-counter medicines, skin products, vitamins and herbal supplements.
BRIEF SUMMARY This summary contains important information about TISSUEBLUE™             WHAT ARE THE POSSIBLE SIDE EFFECTS OF TISSUEBLUE? Adverse reactions that
(TISH-OO-BLU) Solution. It is not meant to take the place of the full Prescribing       have been reported in procedures that included the use of TISSUEBLUE™ have often
Information. Read this information carefully before you prescribe TISSUEBLUE.           been associated with the surgical procedure. The complications include retinal
For full Prescribing Information and Patient Information please see package insert.     (retinal break, tear, hemorrhage, and detachment) and cataracts.
WHAT IS TISSUEBLUE? TISSUEBLUE™ (Brilliant Blue G Ophthalmic Solution) 0.025%           WHAT ARE THE INGREDIENTS IN TISSUEBLUE?
is a disclosing agent indicated to selectively stain the internal limiting membrane
                                                                                        Active Ingredient: Brilliant blue G
(ILM). The drug product will be administered by health care professionals only and
should never be given to patients to handle.                                            Inactive Ingredients: Polyethylene glycol and buffered sodium chloride solution
                                                                                        (sodium chloride, sodium phosphate dibasic dodecahydrate, sodium phosphate
WHO IS TISSUEBLUE FOR? TISSUEBLUE™ is for use in patients who, at the
                                                                                        monobasic dihydrate, water for injection).
recommendation of their eye doctor or ophthalmic surgeon, could benefit from use
of the product when treating vitreoretinal conditions requiring removal of the ILM.     WHERE SHOULD I GO FOR MORE INFORMATION ABOUT TISSUEBLUE? Go to
                                                                                        www.tissueblue.com or call 800-75-DUTCH or 603-778-6929.
WHAT WARNINGS AND PRECAUTIONS SHOULD I BE AWARE OF? Excess
TISSUEBLUE™ should be removed from the eye immediately after staining. When
using the syringe, surgeons or staff should make sure the plunger moves smoothly        Dutch Ophthalmic, USA, 10 Continental Dr., Bldg. 1, Exeter, NH 03833, USA
before injecting the solution.                                                          dorc.eu | 800-75-DUTCH or 603-778-6929

                                                                                                                                                     tissueblue.com
Retina Pipeline? What's in the - Retina Today
RT NEWS                                                  NOVEMBER/DECEMBER 2020
                                                                           V O L . 1 5 , N O . 8 | R E T I N AT O D AY. C O M

                  RETINAL OXIMETRY GIVES CLUES
                  TO CHOROIDAL MALIGNANCY
                     Noninvasive measurements taken with          such as nevi, the authors pointed out.                        nous difference was 34.0% and 32.9%
                  a retinal oximeter detected differences in         “Our study identifies a new param-                         (P = .18), respectively. In patients with
                  oxygenation in eyes with choroidal mela-        eter that differs between [choroidal                          choroidal melanoma, mean ArtSat
                  noma that were not present in eyes with         metastasis] and [choroidal nevus] (ie,                        was 94.8% and 93.2% (P = .006), mean
                  choroidal nevus, a recent study found.          increased oxygen use),” the authors                           VenSat was 58.0% and 60.0% (P = .014),
                  Eyes with choroidal melanoma showed             said. “Because the observed differences                       and mean arteriovenous difference was
                  increases in oxygen saturation in arteri-       […] are small, this will currently not be                     36.8% and 33.2% (P < .001), respectively.
                  oles (ArtSat) and decreased saturation in       of use as a diagnostic criterion, but it                         “These changes [in eyes with mela-
                  venules (VenSat), leading to an increased       demonstrates that melanoma-related                            noma] may be caused by inflamma-
                  arteriovenous difference that was not           vascular alterations are present.”                            tion and a higher metabolism, with
                  seen in eyes with choroidal nevus, the             In the study, retinal oximetry did                         larger oxygen consumption, leading to
                  study authors reported in Retina.1              not differ between the affected and                           altered blood flow and intraocular oxy-
                     Currently, fluorescein angiography,          fellow eyes of patients with choroidal                        gen relocation,” the authors posited.
                  an invasive imaging method, is com-             nevi; mean ArtSat was 94.5% and 94.2%
                                                                                                                                1. Brouwer NJ, Marinkovic M, Bleeker JC, et al. Retinal oximetry is altered in
                  monly used to help differentiate cho-           (P = .56), mean VenSat was 60.5% and                          eyes with choroidal melanoma but not in eyes with choroidal nevi. Retina.
                  roidal metastasis from other lesions            61.3% (P = .35), and mean arteriove-                          2020;40(11):2207-2221.

                  NEW CRISPR TECHNOLOGY                                                       AAO UPDATES
                  SHOWS PROMISE FOR TREATING                                                  CONTINUED IMPROVEMENT SEEN
                  INHERITED RETINAL DISEASES                                                  AT 1 YEAR WITH RPGR GENE THERAPY
                     Correcting mutations in the RPE65 gene using a novel                        An investigational gene therapy for the inherited retinal
                  gene editing technique, known as base editing, significantly                disease X-linked retinitis pigmentosa was well tolerated and
                  restored retinal and visual function in mice with Leber con-                demonstrated significant and sustained improvements in vision
                  genital amaurosis, researchers recently found.                              in a phase 1/2 trial, according to a presentation at the AAO 2020
                     “After receiving treatment, the mice in our study could                  Virtual Annual Meeting. The novel adeno-associated virus/reti-
                  discriminate visual changes in terms of direction, size, con-               nitis pigmentosa GTPase regulator (AAV-RPGR) is being jointly
                  trast, and spatial and temporal frequency,” said Krzysztof                  developed by MeiraGTx and Janssen Pharmaceutical.
                  Palczewski, PhD, the Irving H. Leopold chair and a dis-                        “The continuous upward trend in efficacy we’ve observed
                  tinguished professor in the Gavin Herbert Eye Institute,                    through 1 year with this gene therapy is extremely promising
                  Department of Ophthalmology at the UCI School of                            as a potential way to halt the progression toward blindness
                  Medicine, in a press release. “These results are extremely                  in these patients,” said trial investigator Michel Michaelides,
                  encouraging and represent a major advance towards the                       BSc, MB, BS, MD (Res), FRCOphth, FACS, of Moorfields Eye
                  development of treatments for inherited retinal diseases.”                  Hospital and University College London, who presented
                     The preliminary data suggest that base editing can overcome              12-month data on the therapy at a late-breaking paper session.
                  initial gene therapy barriers, including unpredictable off-target              The primary endpoint of the trial is safety, and secondary
                  mutations and low editing efficiency; in this study, the research-          endpoints are assessing changes in visual function at prespeci-
                  ers were able to correct mutations precisely and predictably,               fied timepoints after treatment. The ongoing trial includes three
                  explained first author Elliot Choi, an assistant specialist in the          phases: dose escalation with low, intermediate, and high doses of
                  UCI Department of Ophthalmology, in the press release.                      AAV-RPGR; dose confirmation; and dose expansion. Statistically

         10 RETINA TODAY | NOVEMBER/DECEMBER 2020

1120RT_News.indd 10                                                                                                                                                                                              12/4/20 3:48 PM
RT NEWS

                                                                                                                                                                  s
                  significant differences in mean retinal sensitivity were observed    prior intraocular inflammation (IOI) and/or prior RO in the
                  between treated and untreated eyes in the intermediate dose          12 months before that first injection, according to an analysis
                  cohort and in central visual field progression rate in the low and   presented at the AAO meeting. Michael S. Ip, MD, presented
                  intermediate dose cohorts, Dr. Michaelides said. In the high dose    the results at the meeting.
                  cohort, inflammation was evident in two of three adults, and            The observed overall risk rate for RV or RO for all brolu-
                  measures of visual function were not improved.                       cizumab-treated patients in the registry was 0.46%, but risk
                     In tests of vision-guided mobility at 9 months, five of six       increased to 3.97% in those with prior IOI and/or RO, the
                  patients demonstrated improvement in walk time for the               database analysis found.
                  treated eye.                                                            In addition, in a post-hoc unmasked assessment of data
                                                                                       from the phase 3 HAWK and HARRIER trials presented by
                                                                                       Jeffrey S. Heier, MD, there was an observed trend toward
                  DATABASE ANALYSIS SHOWS                                              increased incidence of RV or RO in patients with treatment-
                                                                                       emergent anti-drug antibodies.
                  PROGRESSION OF DRY AMD OVER 2 YEARS                                     Further analyses of this data and additional data collection
                     Analysis of real-world clinical data from an AAO data-            on this subject are ongoing, Novartis said in a press release
                  base showed significant disease progression over a 2-year            recapping information presented at the AAO meeting.
                  period in more than 69,000 patients with geographic atro-
                  phy (GA), according to a presentation at the AAO meeting.
                  Patients with GA in one eye secondary to dry AMD were
                  more likely to develop new-onset wet AMD when wet
                                                                                       SAFETY ENDPOINTS MET
                  AMD had already been detected in their contralateral eye,            IN PHASE 1 DRY AMD STUDY
                  the analysis found.                                                     An investigational treatment for dry AMD met all the pri-
                     “The data show that GA patients at their first encounter          mary endpoints in a phase 1 clinical trial, with no treatment-
                  have useful vision that may be preserved if an effective             related adverse events, according to a poster presentation at
                  treatment were available. The progressive loss of visual acu-        the AAO meeting.
                  ity observed in this study over a 2-year period underscores             In four ascending doses of a single intravitreal injection of
                  the urgent need for a therapy to slow disease progression,”          GEM103 (Gemini Therapeutics) there were no dose-limiting
                  said Ehsan Rahimy, MD, who presented the findings at a               toxicities, and all doses were well tolerated, according to pre-
                  late-breaking paper session.                                         senter Arshad M. Khanani, MD, MA. In addition, visual acuity
                     The analysis of data from the AAO’s IRIS Registry was             was generally maintained or improved in the majority of
                  conducted in collaboration with Apellis Pharmaceuticals,             patients with advanced central GA in the open-label study.
                  the data analysis firm Verana Health, and the AAO. Apellis is           Gemini is now evaluating GEM103 in the phase 2a
                  developing pegcetacoplan, a targeted C3 therapy currently in         ReGAtta clinical trial, a multicenter, open-label, multiple-
                  phase 3 clinical studies in patients with GA.                        dose escalation study in patients with GA secondary to dry
                     At 12 months, progression from GA to new-onset wet AMD            AMD, the company said in a press release.
                  was seen in 4.7% of patients with bilateral GA and 13.3% of
                  patients with wet AMD in the contralateral eye. At 24 months,
                  progression was seen in 8.2% and 21.6% of patients with bilat-
                  eral GA and wet AMD in the contralateral eye, respectively.
                                                                                       VITRECTOR HANDLE DESIGNED
                     Of note, a large proportion of patients with GA did not           TO IMPROVE DEXTERITY
                  return for follow-up at 2 years. Of the patients potentially           A new vitrector handle for use on Alcon’s vitrectomy plat-
                  eligible for inclusion in the analysis, only 40% had a 2-year        form was introduced during the 2020 AAO Virtual Annual
                  follow-up visit.                                                     Meeting. The Finesse Reflex handle is designed to help sur-
                                                                                       geons move with ease, providing unrestricted movement
                  DATABASE PROVIDES INSIGHTS ON RISK                                   and focused performance, according to the company.
                                                                                         Part of the Greishaber line of instrumentation for vit-
                  FACTORS FOR RETINAL VASCULITIS WITH                                  reoretinal surgery, the handle provides improved surgical
                                                                                       dexterity with advanced ergonomic support and expanded
                  ANTI-VEGF AGENT                                                      extraocular working space during vitreoretinal surgery, the
                     In 12,000 patients identified in the AAO’s IRIS Registry, the     company said in a press release before the meeting. The
                  highest observed risk for experiencing retinal vasculitis (RV)       ultralight-weight handle features stiff 25- and 27-gauge
                  and/or retinal vascular occlusion (RO) in the 6 months after         needle shafts for maneuverability and precision performance
                  first treatment with brolucizumab (Beovu, Novartis) was              during ophthalmic surgery. n

                                                                                                                       NOVEMBER/DECEMBER 2020 | RETINA TODAY 11

1120RT_News.indd 11                                                                                                                                         12/4/20 3:48 PM
s   MEETING MINUTES

                   PEDIATRIC RETINAL DETACHMENTS
                   REQUIRE DIFFERENT STRATEGIES
                                     Each year, the Aspen Retinal Detachment Society (ARDS) hears from a select group of highly distinguished speakers.
                                     In several of our past meetings, we have made sure to reserve time on the podium to discuss pediatric retinal care.
                                        ARDS leadership knows that most retina conferences give little attention to pediatric retina care. The reasons
                                     are obvious: Pediatric retina is a sub-subspecialty of eye care, and dedicating valuable podium time on an other-
                                     wise filled agenda to a discipline that only a small subset of attendees may practice could be unwise.
                      Still, we know our attendees. ARDS participants’ hunger for learning deeply about a number of subjects is not limited to the topics
                   that pertain most immediately to them and their practices. They’re polymaths. They know that rounding out their retina education
                   gives them a more holistic sense of the space. And hey, you never know when those pediatric retina pearls will come in handy.
                      Be sure to keep an eye on MedConfs.com for the latest updates about ARDS 2021 and our focus on an in-person meeting.
                                                                                                                       —Timothy G. Murray, MD, MBA

                   BEST APPROACHES FOR PEDIATRIC RETINAL DETACHMENTS
                                                                 RD, and trauma are important to               fetal vasculature (PFV) with central reti-
                                                                 document. Pediatric examinations can          nal stalk lines, or peripheral retinal folds
                                                                 be made more challenging due to lack          in retinopathy of prematurity (ROP).
                                                                 of cooperation, difficulty with drop          The short system has the advantage of
                                                                 administration, and poor dilation.            providing a trocar with no cannula.
                   Presentation by Philip J. Ferrone, MD            For babies less than 1 year old, exami-       Pediatric eye anatomy varies from
                   Summarized by Abdallah Mahrous, MD            nation can be made easier by having           that of adults. The pars plana–pars
                       At this year’s ARDS meeting, Philip       the patient lie on a parent’s lap with the    plicata complex extends on average
                   J. Ferrone, MD, provided a rundown of         head by the knees and feet up to the          for 1.87 mm posterior to the limbus
                   surgical considerations for pediatric reti-   parent’s chest, while the parent helps        at 40 weeks; therefore, introducing
                   nal detachments (RDs). He emphasized          stabilize the baby by holding his or her      the cannulas at 1 mm from the lim-
                   the important point that the anatomy          head. For uncooperative children up to        bus is appropriate for a term baby. By
                   of pediatric eyes is different from the       8 years of age, you can ask the parent        6 months, the pars plana–pars plicata
                   anatomy of adult eyes, and he discussed       to bear-hug the child while an assis-         complex extends for approximately
                   the best approaches to use in a variety       tant holds the head and the physician         3 mm posterior to the limbus, so a
                   of presentations. This article summa-         attempts to pry the eyelids open and          trocar incision at 1.5 to 2.0 mm from
                   rizes portions of his presentation.           examine. If this approach fails, examina-     the limbus is appropriate for that age.
                                                                 tion under anesthesia is often necessary.        The eye’s anatomy continues to
                    HISTORY AND EXAMINATION TIPS                    Stickler detachments are often com-        change with the child’s growth. The
                      Dr. Ferrone reported that pediatric        plicated, with a redetachment rate of         axial length increases by approximately
                   RDs have an incidence of 0.53 per             45% due to proliferative vitreoretinop-       1.5 mm during the first 12 weeks of
                   100,000, compared with an inci-               athy (PVR). By contrast, non-Stickler         life. The eye grows on average 2 mm
                   dence of 12 per 100,000 in the adult          RDs often behave more like adult RDs          over the first 2 years of life and then
                   population.1 Tractional RDs are even          with more promising results.                  another 2 mm from 2 years to 5 years.
                   less common in children. RDs are                                                            Between 5 years and 15 years the eye
                   sometimes challenging to diagnose in           SURGICAL APPROACHES                          typically grows another 3 mm. After
                   children, and they can present late or           The standard Alcon kit for 25-gauge        15 years of age, there is typically no
                   with other signs such as strabismus.          vitrectomy can often be used for com-         significant growth.2 It is important
                      History is important, even in older        mon pediatric RDs. Use of the special         to take this progression into account
                   children—details such as a baby’s             Alcon short 25-gauge instrumentation          when scleral buckle surgery is con-
                   birth weight, a history of prematurity,       can be helpful in cases such as microph-      sidered and when you are placing
                   or a family history of eye disease or         thalmic eyes, or eyes with persistent         sclerotomy wounds.

          12 RETINA TODAY | NOVEMBER/DECEMBER 2020

1120RT_Meeting Minutes_ARDS_Imaging_Paulose.indd 12                                                                                                           12/4/20 4:04 PM
MEETING MINUTES

                                                                                                                                                                                        s
                   Eyetube Meeting Coverage at Aspen Retinal Detachment Society
                   Each year, the Society invites Eyetube to cover selected talks from the year’s agenda.

                   ARTIFICIAL INTELLIGENCE AND PEDIATRIC RETINA                                       SUBRETINAL GENE THERAPY
                   R.V. Paul Chan, MD, discusses how applying AI to pediatric patients aids in        Christina Weng, MD, MBA, gives insight into ongoing subretinal gene therapy
                   diagnosing conditions such as plus disease by characterizing and monitoring        pipeline candidates, specifically voretigene neparvovec for patients with a
                   disease activity.                                                                  mutation of the RPE65 gene.

                                                                           BIT.LY/ARDSCHAN                                                                      BIT.LY/ARDSWENG

                   BEST APPROACHES FOR PEDIATRIC RD                                                   NEUROPROTECTION FOR THE TREATMENT OF THE RETINA
                   Philip J. Ferrone, MD, discusses how to properly care for and diagnose pediatric   Baruch Kuppermann, MD, PhD, discusses unmet needs in conditions such
                   patients. Dr. Ferrone discusses how fundus autofluorescence, OCT, and other        as retinal detachment, geographic atrophy, and dry AMD and what the right
                   in-office imaging modalities can be used to obtain the best and most accurate      pathway may be for neural protection and enhancement.
                   imaging results.

                                                                       BIT.LY/ARDSFERRONE                                                         BIT.LY/ARDSKUPPERMANN

                                                  Want to see the whole video collection? Head to bit.ly/ARDS2020.

                    CASE-BY-CASE CONSIDERATIONS                              these RDs often requires time and                    lasered. If not treated, these areas can
                      Pediatric RDs should be approached                     patience. They might require multiple                lead to dense preretinal proliferation
                   on a case-by-case basis. Retinal dialysis                 surgeries, with relaxing retinectomies               with high-ridged retinal folds. The folds
                   should preferably be buckled using a                      and silicone oil.                                    must be carefully dissected, taking care
                   low and broad approach, as opposed                          Familial exudative vitreoretinopathy               not to create any retinal breaks, which
                   to a high and narrow one. Stickler                        (FEVR) may present with a normal                     would be very difficult to repair.
                   detachments, as previously men-                           appearing fundus, but fluorescein                       Mutations in KIF11 can cause micro-
                   tioned, are highly proliferative with                     angiography can reveal large areas of                cephaly, microphthalmia, and con-
                   high redetachment rates. Addressing                       peripheral nonperfusion that can be                                    (Continued on page 15)

                                                                                                                                             NOVEMBER/DECEMBER 2020 | RETINA TODAY 13

1120RT_Meeting Minutes_ARDS_Imaging_Paulose.indd 13                                                                                                                                 12/4/20 4:04 PM
s   IMAGING

                   DOUBLE TROUBLE: A TALE OF TWO
                   INTRAOCULAR FOREIGN BODIES
                                                                Imaging might be wise, even when one object is clearly visible.
                                                                 BY REMYA MAREEN PAULOSE, MBBS, DNB, FLVPEI, FICO, FAICO, AND
                                                                 THOMAS CHERIAN, MS, FLVPEI

                  I
                      ntraocular foreign body (IOFB) injuries may result in a wide                                   CASE
                      range of pathology and visual outcomes. Metallic IOFBs are                                       A healthy 24-year-old man presented urgently with a
                      often associated with high velocity, and once they penetrate                                  penetrating corneoscleral injury of the right eye following a
                      the cornea, they tend to enter the posterior segment.1-3                                      reported history of a high-velocity projectile resulting from
                      Additionally, IOFBs may present with varied clinical aspects                                  hammering a nail. He complained of poor vision, pain, and
                   that may limit their detection, and symptoms may only                                            redness in the right eye.
                   become apparent after a prolonged period of time.                                                   His visual acuity was light perception in the right eye and
                       However, in cases of visible IOFB, there are no clear guide-                                 20/20 in the left. In the right eye, the conjunctiva was con-
                   lines regarding the need for additional imaging.                                                 gested with a full thickness corneoscleral tear at 4 o’clock,
                       This report describes a unique case of a single penetrating                                  extending 3 mm onto the cornea and 5 mm radially onto the
                   wound with two metallic IOFBs, one of which would have                                           sclera. The anterior chamber was shallow, and the pupil was
                   been overlooked on a cursory clinical examination. It high-                                      mid-dilated with a relative afferent pupillary defect. Although
                   lights the need for suspicion of additional foreign bodies even                                  a rosette cataract was present, the fundus could be visualized,
                   if one IOFB is clinically evident.                                                               showing a metallic IOFB embedded on the retina inferonasally
                       A                                                                                             B

                       C                                                                                             D

                      Figure: Fundus imaging reveals a large macular tear caused by a high-velocity impact (A). Note the large visible metallic IOFB on the inferonasal retina (B). A second IOFB, hidden in
                      the inferonasal periphery, was localized with the help of a CT scan (C); the CT scan helped to localize the anterior smaller foreign body (left), while the larger foreign body is visible
                      in a posterior scan (right). The larger visible foreign body was brought into the anterior chamber (left), and the smaller anterior foreign body in the periphery was localized with
                      scleral indentation (right) (D).

          14 RETINA TODAY | NOVEMBER/DECEMBER 2020

1120RT_Meeting Minutes_ARDS_Imaging_Paulose.indd 14                                                                                                                                                                12/7/20 9:20 AM
IMAGING                                                                                                                            MEETING MINUTES

                                                                                                                                                                        s

                                                                                                                                                                                                                                                                                                           s
                   (Figure, A). The macula showed a large retinal tear with an                                                                                               (Continued from page 13)
                   overlying hemorrhage (Figure, B).                                                                                                                         genital retinal folds. Fluorescein studies may show peripheral
                      The patient underwent fundus photography and emer-                                                                                                     nonperfusion as well. Retinal folds can sometimes have stalks
                   gency CT scan as per institution protocol. To our surprise,                                                                                               that connect to the lens. The preferred surgical approach in
                   CT imaging revealed two separate IOFBs in the inferonasal                                                                                                 these eyes is to use the short 25-gauge instruments, cutting
                   aspect of the right eye (Figure, C).                                                                                                                      the stalk anteriorly to free up the retina and letting it settle
                      The patient was scheduled for emergency 25-gauge pars                                                                                                  back down to a more normal anatomy, then approaching
                   plana vitrectomy and pars plana lensectomy with anterior                                                                                                  the rest of the retinal folds.
                   capsulotomy. Posterior vitreous detachment nasally helped to                                                                                                 Optic pit RDs can sometimes self-resolve if given time;
                   avoid the extension of the macular tear. After vitrectomy, the                                                                                            however, in cases that require surgery it is recommended
                   larger of the two foreign bodies was removed through a clear                                                                                              to remove the vitreous stalk that goes right into the optic
                   corneal incision, while a thorough search with scleral indenta-                                                                                           pit, followed by application of light intraoperative laser
                   tion localized the second IOFB in the peripheral retina close to                                                                                          around the pit.
                   the ora (Figure, D). The second one was removed in a similar                                                                                                 In Coats disease, the pathognomonic telangiectatic
                   manner. Cryotherapy was applied to the peripheral break, fol-                                                                                             vessels are often accompanied by RDs. In these eyes, it is
                   lowed by silicone oil tamponade. After silicone oil removal at                                                                                            better to drain the subretinal fluid externally and apply
                   3 months postoperatively, visual acuity improved to counting                                                                                              extensive laser to the telangiectatic vessels; this might not
                   fingers at 3 m with attached retina and scarring at the macula.                                                                                           provide ideal results but will preserve any vision possible.
                                                                                                                                                                                Colobomas can present with very challenging RDs.
                    DISCUSSION                                                                                                                                               Silicone oil is preferred in these eyes, but even with oil
                      The identification of an additional foreign body can be chal-                                                                                          there are often redetachments due to the complexity of
                   lenging when the level of suspicion is low, as can be the case                                                                                            the retinal layers in the coloboma. Platelet-rich plasma can
                   when one IOFB is clinically visible. General consensus is lacking                                                                                         be helpful in these cases.
                   regarding the need for imaging in cases with visible IOFB.
                      In one interventional case series of 69 eyes with IOFBs,                                                                                                CONCLUSION
                   17 eyes had no imaging when the IOFB was easily visualized.1                                                                                                Pediatric RDs are different from RDs in adults.
                   The researchers also reported that two eyes had an additional                                                                                             Children’s eyes have a different anatomy that requires
                   IOFB identified on radiological evaluation. Thus, the authors                                                                                             modification of surgical approaches. With the correct
                   recommended radiologic imaging even when an IOFB is                                                                                                       approach and patience, excellent visual and anatomic
                   clearly visible on clinical examination. A retrospective review                                                                                           results are still possible. n
                   of imaging techniques in IOFB cases demonstrated the superi-
                                                                                                                                                                             1. Nuzzi R, Lavia C, Spinetta R. Paediatric retinal detachment: a review. Int J Ophthalmol. 2017;10(10):1592-1603.
                   ority of CT scan over other methods.4                                                                                                                     2. Maldonado RS, Izatt JA, Sarin N, et al. Optimizing hand-held spectral domain optical coherence tomography imaging for
                      To the best of our knowledge, this is a unique report of two                                                                                           neonates, infants, and children. Invest Ophthalmol Vis Sci. 2010;51(5):2678-85.
                   metallic IOFBs from a single entry site caused by a hammering
                   accident. I speculate that the force of the IOFB’s impact on
                   the macula may have caused the IOFB to split in two inside                                                                                                CORRESPONDING AUTHOR ABDALLAH MAHROUS, MD
                   the eye. This case highlights the need for suspicion and imag-                                                                                            nV  itreo-Retinal Surgery Fellow, Weill Cornell Medicine, New York
                   ing for additional IOFBs in the event of high velocity projectile                                                                                         n a mahrus89@gmail.com

                   injuries, even when one IOFB is clinically evident. n                                                                                                     nF  inancial disclosure: None
                   1. Woodcock MG, Scott RA, Huntbach J, Kirkby GR. Mass and shape as factors in intraocular foreign body injuries. Ophthalmology. 2006;113(12):2262-2269.
                   2. Roper-Hall MJ. Review of 555 cases of intra-ocular foreign body with special reference to prognosis. Br J Ophthalmol. 1954;38:65-99.
                                                                                                                                                                             PHILIP J. FERRONE, MD
                   3. Percival SP. A decade of intraocular foreign bodies. Br J Ophthalmol. 1972;56:454-461.                                                                 nR etinal Surgeon, Long Island Vitreoretinal Consultants, Great Neck, New York
                   4. Nie S, Wang Z, Liu W, Liang X. Clinical application of X-ray, B-scan, and CT in the diagnosis of ocular foreign bodies. Eye Sci. 2013;28(1):11-4.      nF inancial disclosure: None acknowledged

                   THOMAS CHERIAN, MS, FLVPEI
                   n Vitreoretinal Consultant, Little Flower Hospital and Research Center, Angamaly, Kerala, India

                   n Financial disclosure: None

                   REMYA MAREEN PAULOSE, MBBS, DNB, FLVPEI, FICO, FAICO
                   n  Vitreoretinal Consultant, Little Flower Hospital and Research Center, Angamaly, Kerala, India
                   n r emyapaulose@gmail.com

                   n Financial disclosure: None

                                                                                                                                                                                                                                           NOVEMBER/DECEMBER 2020 | RETINA TODAY 15

1120RT_Meeting Minutes_ARDS_Imaging_Paulose.indd 15                                                                                                                                                                                                                                                     12/4/20 4:05 PM
s   MEDICAL RETINA

                    LONG-TERM INFLAMMATION CONTROL
                    BENEFITS ALL TYPES OF UVEITIS
                                        Preventing flare-ups is essential in the pandemic era.
                                        BY ROBERT C. WANG, MD

                  U
                           veitis is a multifaceted disease      dose of steroid.                               with systemic methotrexate and had
                           that strikes in different ways, but      As the following case studies illus-        been using topical prednisolone ace-
                           the goal of treatment is always       trate, a thorough evaluation of the            tate in the right eye for the 2 months
                           the same: to achieve quiescence       patient’s clinical presentation and medi-      before presentation (Figure 1).
                           with the fewest possible side         cal history guide the development of a
                    effects. Whether a patient presents          well-suited uveitis treatment regimen,         Treatment Course
                    with iritis, panuveitis, or uveitis with     and frequent monitoring makes it pos-             I started the patient on topical
                    systemic disease association, the retina     sible to change course when necessary.         0.05% difluprednate ophthalmic emul-
                    specialist’s objective is to eradicate                                                      sion (Durezol, Alcon) as a bridge to
                    vision-threatening inflammation and           CASE 1: ANTERIOR UVEITIS                      initiation of systemic adalimumab
                    quell potential flares. To that end, we      Presentation                                   (Humira, AbbVie). With the topical
                    have an increasingly sophisticated arse-        A 9-year-old White child was                treatment, the CME improved greatly,
                    nal of tools from which to choose.           brought to the clinic for evaluation           although the patient developed a mild
                       By the time patients with noninfec-       and treatment. The patient had a his-          steroid-induced IOP response, with
                    tious uveitis reach my clinic, they have     tory of psoriatic arthritis and decreased      elevation to 27 mm Hg.
                    typically been treated unsuccessfully        vision in her right eye. She presented            I replaced the difluprednate with
                    with oral steroids and are then candi-       with rebound iritis and worsening              0.5% loteprednol etabonate ophthal-
                    dates for systemic immunosuppres-            vision. The most common causes of              mic suspension (Lotemax, Bausch
                    sives or intraocular corticosteroids.        vision loss in pediatric patients with         + Lomb) and gradually tapered
                    Options at this point include the bio-       anterior uveitis are cataract, band kera-      the loteprednol to one drop daily.
                    erodible 0.7 mg dexamethasone intra-         topathy, glaucoma, and cystoid macu-           Adalimumab was started 2 weeks
                    vitreal implant (Ozurdex, Allergan); the     lar edema (CME).                               after the loteprednol taper, result-
                    surgically placed 0.59 mg fluocinolone          On presentation, the patient’s VA           ing in resolution of most of the CME.
                    acetonide intravitreal implant (Retisert,    was 20/40 OD and 20/20 OS, and OCT             The patient’s IOP returned to normal
                    Bausch + Lomb); and the inject-              documented CME in the right eye. The           (11 mm Hg) and visual acuity stabilized
                    able 0.18 mg fluocinolone acetonide          patient had been treated on and off            at 20/25 (Figure 2).
                    intravitreal implant (Yutiq, EyePoint
                    Pharmaceuticals).
                       When appropriate, I am partial to              AT A GLANCE
                    the newest option, the 0.18 mg fluocin-
                    olone acetonide intravitreal implant,                 T he goal of uveitis treatment is to achieve quiescence with the fewest
                                                                      s

                    because it is a low-dose implant that                  possible side effects.
                    lasts up to 3 years. I’ve treated many
                    patients with it who have then expe-                  A number of implantable posterior segment steroid options exist for
                                                                      s

                    rienced long-term quiescence and few
                    side effects. The 0.59 mg fluocinolone
                                                                           local control of inflammation.
                    acetonide intravitreal implant is also
                                                                          Ongoing coverage is a chief advantage of an implantable corticosteroid.
                                                                      s

                    an excellent option, but it requires sur-
                    gical placement and delivers a higher

           16 RETINA TODAY | NOVEMBER/DECEMBER 2020

1120RT_MedicalRetina_Oncology.indd 16                                                                                                                     12/4/20 4:09 PM
MEDICAL RETINA

                                                                                                                                                                                                  s
                     Figure 1. The Case 1 patient’s OCT shows CME secondary to chronic iritis in the right eye (left panels), normal left eye.

                     Figure 2. The Case 1 patient’s OCT demonstrates resolution of CME in the right eye.

                    Current Status                                                                                       At that point, it was clear to me that the patient’s disease
                       Ten months after initiation of adalimumab, the patient’s                                       would continue to flare without a move to local therapy. I placed
                    visual acuity remains 20/25 OD and 20/20 OS with normal                                           a 0.7 mg dexamethasone intravitreal implant in the vitreous,
                    IOP and no recurrence of inflammation or CME.                                                     after which the inflammation improved rapidly. This implant is
                                                                                                                      expected to last up to 6 months, but I often find that its efficacy
                     CASE 2: PANUVEITIS                                                                               wanes by about month 3, and pharmacokinetic data supports
                    Presentation                                                                                      that observation.2
                       A 72-year-old White woman presented with panuveitis                                               I discussed with the patient the possibility of implanting
                    secondary to birdshot chorioretinopathy positive for histo-                                       the 0.59 mg fluocinolone acetonide intravitreal implant,
                    compatibility leukocyte antigen (HLA)-A29. Birdshot cho-                                          but the patient was concerned about a higher incidence of
                    rioretinopathy is a rare form of chronic bilateral posterior                                      glaucoma with this treatment in patients with birdshot cho-
                    uveitis. Despite its distinctive clinical phenotype and associa-                                  rioretinopathy.3 In addition, the anticipated out-of-pocket
                    tion with HLA-A29, delays in diagnosis and treatment are                                          cost was beyond her means. Instead, she elected to repeat
                    common, sometimes resulting in significant visual loss.1                                          the dexamethasone implant every 3 months for nine more
                                                                                                                      treatments.
                    Treatment Course                                                                                     The 0.18 mg fluocinolone acetonide intravitreal implant sub-
                      Because birdshot chorioretinopathy is thought to have an                                        sequently became available. The patient was amenable to trying
                    autoimmune etiology, therapy aims to regulate the body’s                                          it when I explained that it would be implanted in an outpatient
                    immune response. I started the patient on oral prednisone                                         procedure under topical anesthesia, that it would last for 3 years,
                    and 50 mg of the antimetabolite azathioprine (Imuran,                                             and that the reimbursement would be favorable.
                    GlaxoSmithKline) three times daily. I began a taper of the
                    oral steroids, and the patient achieved quiescence, but                                           Current Status
                    4 months later she developed a recurrence of inflammation.                                          I placed the 0.18 mg fluocinolone acetonide intravitreal
                      At that time, I initiated a pulse of oral steroids, which                                       implant bilaterally in December 2019. Since then, her eyes
                    calmed the inflammation, and I prescribed 150 mg of aza-                                          have remained quiet with no other therapy needed.
                    thioprine and 5 mg of prednisone daily for maintenance
                    therapy. However, she again developed a flare 3 months later.                                      CASE 3: UVEITIS WITH SYSTEMIC ASSOCIATION
                    We attempted to enroll her in a clinical trial of adalimumab,                                     Presentation
                    but the study had reached its closeout date. I consulted with                                        A 74-year-old White man presented with bilateral
                    rheumatology, intending to initiate systemic biologic thera-                                      nyctalopia and vision loss. The patient had a history of
                    py. With no other systemic diagnosis, however, the patient’s                                      autoimmune neuropathy predominantly affecting his right
                    insurance carrier would not approve any therapy.                                                  leg and, to a lesser degree, his left leg and both hands. He also
                      I increased the dose of azathioprine to 200 mg daily, but                                       had hearing loss, with cochlear implants bilaterally, and he
                    the patient still demonstrated inflammation on exam. Next, I                                      was being treated with azathioprine for Sjögren syndrome. On
                    switched her to a daily regimen of 3,000 mg of mycophenolate                                      examination, he had 20/20 VA OU and normal retina findings
                    mofetil (CellCept, Genentech) and initiated another steroid                                       but very constricted visual fields bilaterally.
                    pulse. Despite the switch, the inflammation flared once again.                                                                                (Continued on page 21)

                                                                                                                                                       NOVEMBER/DECEMBER 2020 | RETINA TODAY 17

1120RT_MedicalRetina_Oncology.indd 17                                                                                                                                                       12/4/20 4:09 PM
You can also read