- FDA approves first bispecific antibody for the eye
- FDA approves treatment for rare uveal melanoma
- New data on clinical programs investigating phentolamine ophthalmic solution
- Phase 2 clinical trial results published for investigational drug targeting allergic conjunctivitis
- Patient dosing begins for gene therapy to treat X-linked retinitis pigmentosa
- New effort to research glaucoma
- ASCRS news and events
February 4, 2022 • Volume 28, Number 5
FDA approves first bispecific antibody for the eye
The FDA approved Genentech’s Vabysmo (faricimab-svoa) for the treatment of wet AMD and diabetic macular edema. Vabysmo, according to the company’s press release, is the first bispecific antibody for the eye, targeting and inhibiting angiopoietin-2 and VEGF-A. Vabysmo is designed to improve and maintain vision with treatments 1 to 4 months apart in the first year, after four initial monthly doses (dosing schedules are determined based on patient anatomy and vision outcomes). The current standard of care for wet AMD and DME follows monthly or bimonthly injections.
FDA approves treatment for rare uveal melanoma
Immunocore announced FDA approval of KIMMTRAK (tebentafusp-tebn) for treatment of unresectable or metastatic uveal melanoma, the first and only treatment now approved for this indication. The company described KIMMTRAK as the first T cell receptor therapeutic to receive regulatory approval. In clinical trials it demonstrated a statistically and clinically significant overall survival benefit.
New data on clinical programs investigating phentolamine ophthalmic solution
Ocuphire Pharma hosted a virtual R&D day in which it provided several updates on its clinical programs, including for Nyxol (0.75% phentolamine ophthalmic solution). This lead candidate is a non-selective alpha-1 and alpha-2 adrenergic inhibitor and is being investigated for the temporary treatment of presbyopia and mydriasis reversal. According to the company’s press release, new data from the Phase 2 VEGA-1 clinical trial for presbyopia showed that it had a statistically significant improvement in efficacy and long durability compared to placebo at 12 hours post-dosing, which the company stated supports future development as a single drop. The company plans to proceed with a Phase 3 VEGA trial to file an NDA for both the single drop and with low-dose pilocarpine as an adjunctive treatment. Separately, the company’s Phase 3 trial for reversal of mydriasis met its primary endpoint.
Phase 2 clinical trial results published for investigational drug targeting allergic conjunctivitis
Aldeyra Therapeutics announced publication of its Phase 2 clinical trial investigating reproxalap, a first-in-class reactive aldehyde species modulator, as a possible treatment for patients with allergic conjunctivitis. The study, published in the journal Clinical Ophthalmology, included 70 adults with a history of moderate to severe allergic conjunctivitis for at least 2 years. Participants also had a positive skin test to ragweed pollen and ocular itching and redness scores after allergy chamber exposure of 2.5 or more or 2 or more, respectively. There were three treatment groups (0.5% reproxalap, 0.25% reproxalap, and vehicle). Treatments were administered in both eyes before entering the allergy chamber and 90 minutes afterward. Participants were exposed to the allergy chamber, which involved aerosolized ragweed pollen, for 3.5 hours. Both study groups showed rapid, statistically significant improvement of patient-reported ocular itching and tearing and investigator-assessed ocular redness, compared to the vehicle group, according to the company’s press release. This improvement in signs and symptoms lasted for the duration of exposure in the chamber as well as assessment after exposure.
Patient dosing begins for gene therapy to treat X-linked retinitis pigmentosa
MeiraGTx and Janssen Pharmaceutical Companies have begun dosing patients with X-linked retinitis pigmentosa with botaretigene sparoparvovec in the Phase 3 LUMEOS trial. Botaretigene sparoparvovec (formally called AAV-RPGR) is an investigational gene therapy for disease caused by variants of the RPGR gene. It is designed to deliver functional copies of this gene to improve and preserve vision.
New effort to research glaucoma
Heidelberg Engineering announced that it is joining the Glaucoma/Myopia OCT Phenotyping Consortium (GMOPC), a research effort to improve detection of glaucoma. According to the company’s press release, the GMOPC was established in February 2020 with 13 clinical centers in seven countries. It hopes to gain scientific insights to help clinicians detect glaucoma earlier and improve patient care. Data collection for this effort is set to begin this year. Heidelberg’s press release stated that this is the largest research project the company has ever supported, doing so with its hardware and software technologies.
ASCRS news and events
- 2022 ASCRS Annual Meeting: Browse the recently released Preview Program for the ASCRS Annual Meeting in Washington, D.C., April 22–26, 2022. There is also an open call for complicated case video submissions.
- Beyond 20/20: Beyond 20/20: An ASCRS Series in Modern Refractive Surgery and Presbyopia Therapy is a new, four-part educational series sponsored by the Refractive Clinical Committee that features CME and non-CME components. Learn more about the series and register here.
- Eyecelerator@ASCRS: Eyecelerator@ASCRS is welcoming the Winning Pitch Challenge to its program, taking place April 21 ahead of the ASCRS Annual Meeting in Washington, D.C. The Winning Pitch Challenge supports physician entrepreneurs and is accepting submissions now. Learn more about the challenge, the submission process, and deadlines here.
Research highlights
- The risk of a severe, complicated adverse reaction for patients taking oral or topical carbonic anhydrase inhibitors was evaluated in a population-based cohort study of 128,942 individuals. The authors of this study published in JAMA Ophthalmologywrote that some ophthalmologists may be reluctant to prescribe oral carbonic anhydrase inhibitors due to potential life-threatening systemic adverse reactions. This study, however, found that the risk of serious adverse reaction following oral or topical carbonic anhydrase inhibitor was low and similar. “Given the low risk of severe adverse reactions, this population-level analysis supports reconsidering the reluctance toward prescribing an oral carbonic anhydrase inhibitor,” the authors wrote.
- Studying the effect of pharmacological mydriasis on IOP in eyes with functioning blebs, compared to normal eyes, was the goal of a cross-sectional study, which included 39 eyes (19 of which had filtering blebs and 20 of which had no prior ocular surgeries). IOP was measured with Goldmann tonometry before and 30 minutes after topical tropicamide application. The authors reported being surprised to find that pupillary dilation reduced IOP in eyes with successful trabeculectomy. They wrote that this is “different from the usual effect of raising the IOP as in the control group” and that it “has not been previously studied.” In eyes with blebs, the IOP prior to tropicamide was 13.68±3.4 mm Hg; it was 11.95±3.03 mm Hg after pupillary dilation. Those without blebs had an IOP of 15.9±3.00 mm Hg at baseline that increased to 18.4±2.9 mm Hg after dilation. This study was published in the journal Clinical Ophthalmology.
This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.
EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), is published every Friday, distributed by email, and posted live on Friday.
Medical Editors: Eric Donnenfeld, MD, Chief Medical Editor; Rosa Braga-Mele, MD, Cataract Editor; Clara Chan, MD, Cornea Editor; Nathan Radcliffe, MD, Glaucoma Editor; and Vance Thompson, MD, Refractive Editor
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