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Quick Notes: August 11, 2023

FDA approves Iveric Bio’s IZERVAY for geographic atrophy; Oculis reports positive Phase 3 data for OCS-01 eyedrops; and more.

Ophthalmology Management August 11, 2023

  • The FDA approved IZERVAY (avacincaptad pegol intravitreal solution) from Iveric Bio, an Astellas company, for the treatment of geographic atrophy (GA) secondary to AMD. IZERVAY, a new complement C5 inhibitor, is the first approved GA treatment with a statistically significant reduction (p<0.01) in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials. The FDA approval was based on the GATHER1 and GATHER2 Phase 3 clinical trials. In each registrational trial, over a 12-month period, the primary analysis showed a statistically significant reduction in the rate of GA growth in patients treated with IZERVAY compared to sham. Slowing of disease progression was observed as early as 6 months with up to a 35% reduction in the first year of treatment. IZERVAY is anticipated to be available in the United States in 2-4 weeks.

  • Oculis Holding AG announced positive topline results from its Phase 3 OPTIMIZE trial with OCS-01 eyedrops, a novel, once-daily, high concentration, preservative-free, topical OPTIREACH formulation of dexamethasone for the treatment of inflammation and pain following ocular surgery. The trial met both hierarchical primary efficacy endpoints, the absence of inflammation at Day 15 and the absence of pain at Day 4. The percentage of eyes with zero inflammation (absence of anterior chamber cells, score = 0) was statistically significantly greater with OCS-01 q.d. compared with vehicle at Day 15 (OCS-01, 57.2% vs vehicle, 24.0%, p<0.0001); and the percentage of eyes with zero pain (absence of pain, score = 0) was statistically significantly greater with OCS-01 q.d. compared with vehicle at Day 4 (OCS-01, 75.5% vs vehicle, 52.0%, p<0.0001). If approved, OCS-01 will be the first once-daily, topical, preservative-free corticosteroid for treating inflammation and pain following ocular surgery. For more, see the trial results here.

  • Regeneron Pharmaceuticals announced positive 2-year topline data from the pivotal PULSAR trial investigating aflibercept 8 mg in patients with wet AMD. During the trial, aflibercept 8 mg patients were initially randomized to either 12- or 16-week dosing intervals (after three initial monthly doses) and were able to shorten or extend dosing intervals if pre-specified criteria were met. The longer-term data follow the positive 2-year results for PHOTON with diabetic macular edema, with PULSAR similarly demonstrating that the vast majority of aflibercept 8 mg patients with wet AMD were able to maintain or further extend their dosing intervals. Among those who completed the 2-year follow-up: 88% were on a ≥12-week dosing interval at the end of 2 years; 78% maintained ≥12-week dosing intervals throughout the 2-year study period, compared to 83% throughout the first year of study; and 71% met the extension criteria for even longer dosing intervals, including 47% for ≥20-week intervals and 28% for 24-week intervals. For more, see the study results here.

  • Prevent Blindness announced the launch of its “Eyes on Capitol Hill” advocacy resource: Advocacy.PreventBlindness.org. It is designed to educate and empower advocates with the information and necessary tools needed to successfully advocate for policies that preserve sight. Features of the website include: Up-to-date policy information that also dives into Prevent Blindness positions on issues that affect vision and eye health; skill-building resources designed to educate aspiring advocates on the basics of vision and eye health policy and Congressional advocacy, empower them to meet with legislators, and connect their personal experiences to vision and eye health policy; and a new Legislative Action Center designed to provide advocates with direct access to their representatives in Washington, D.C., as well as to their local media outlets. For more information on Prevent Blindness’ advocacy efforts, click here.

 

  • HuidaGene Therapeutics, a clinical-stage biotechnology company focused on developing CRISPR-based programmable genomic medicines, announced the FDA granted Rare Pediatric Disease Designation (RPDD) to HG004 for the treatment of inherited retinal disease caused by RPE65 mutations (RPE65-IRDs). HG004 was granted both RPDD and orphan drug designation by the FDA in March. Data from the company’s preclinical studies have shown that HG004 demonstrates significant superiority in the recovery of retinal function of the RPE65 mice.

 

  • Euclid Vision announced the passing of George E. Glady, one of the company's founders. Mr. Glady was a pioneer in Ortho-K contact lenses, which has been used by millions of patients — both children and adults — around the world to slow the progression of myopia. Today, Ortho-K contact lenses are a widely recognized alternative for vision correction. Contributions in memory of George E. Glady may be made to: Unitarian Universalist Service Committee (UUSC.org), an international relief organization, Gas Permeable Lens Institute (Beth@GPLI.info), a contact lens educational organization, or Wayland Historical Society (info@waylandnuseum.org). 

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.