Ocugen dosed the first patient in its global Phase 3 registrational trial, ArMaDa3. This study evaluates OCU410 as a one-time gene therapy for geographic atrophy (GA). GA is an advanced form of dry age-related macular degeneration that causes irreversible vision loss.
The trial will enroll 237 participants randomized to receive a single subretinal injection or remain untreated. This pivotal study follows FDA alignment on the trial design. OCU410 recently received Regenerative Medicine Advanced Therapy (RMAT) designation to accelerate the review process. Ocugen anticipates filing a Biologics License Application (BLA) in 2028.