Ocugen, Inc. announced today that dosing is complete, ahead of schedule, in the Phase 2 portion of the Phase 1/2 ArMaDa clinical trial for OCU410. OCU410 is a novel multifunctional modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). This achievement represents a major accomplishment for the OCU410 program.
The Phase 2 study assessed the safety and efficacy of OCU410 in 51 patients with GA secondary to dAMD, who were randomized into two treatment groups or a control group. Preliminary efficacy and safety data from the Phase 1/2 study have been highly encouraging. OCU410 is designed as a one-time treatment, targeting multiple pathways associated with GA, unlike current limited options that require frequent injections.
The data from this completed Phase 2 trial will be crucial in designing a future pivotal Phase 3 study, which is planned for 2026. This progression supports Ocugen's commercial strategy for Biologics License Application (BLA) and Marketing Authorization Application (MAA) filings as soon as 2028. GA affects approximately 2-3 million people in the U.S. and Europe, highlighting the significant unmet medical need OCU410 aims to address.
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