MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) this week announced the completion of dosing in the third cohort of its Phase 1/2 ArMaDa clinical trial for OCU410, a novel gene therapy candidate for geographic atrophy (GA). GA is an advanced stage of dry age-related macular degeneration (dAMD) affecting about 1 million people in the United States.
Dr. Majda Hadziahmetovic, Associate Professor of Ophthalmology at Duke University Eye Center and the lead investigator for the trial, highlighted the potential impact of OCU410. “Currently, there are two FDA-approved anti-complement therapies for GA, which target only one pathway for a disease that has a multifactorial and complex etiology,” she said. “Though these treatments are a significant milestone, they provide limited benefits and involve a continuous regimen of multiple intravitreal injections over several years. This modifier gene therapy could potentially transform the landscape of GA treatment.”
In this trial, three subjects received a single subretinal administration of the highest dose, completing the dosing for Phase 1. The treatment centers include 14 leading retinal surgery centers across the U.S.
Dr. Huma Qamar, Chief Medical Officer of Ocugen, expressed optimism about the therapy’s potential. “We are very encouraged about the potential of OCU410 as a one-time treatment option for GA,” he said.
The company has already initiated Phase 2 of the trial, which will assess the safety and efficacy of OCU410 in a larger group. Patients will be randomized into either medium- or high-dose treatment groups or a control group.
The ArMaDa Phase 1/2 clinical trial aims to evaluate the safety of unilateral subretinal administration of OCU410 in subjects with GA. Phase 1 is a multicenter, open-label, dose-escalation study with three dose levels. Phase 2 will be a randomized, outcome accessor-blinded, dose-expansion study.
Dry age-related macular degeneration (dAMD) is a significant health concern, affecting approximately 10 million Americans and more than 266 million people worldwide. It is characterized by the thinning of the macula, the part of the retina responsible for clear vision. dAMD accounts for 85-90% of all age-related macular degeneration cases, involving slow retinal deterioration, submacular drusen, atrophy, and central vision impairment.
Ocugen’s progress with OCU410 holds promise for a more effective, long-term treatment for GA, potentially improving the quality of life for millions affected by this debilitating condition.
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