OCU410 - (ArMaDa)

July 29, 2026: Ocugen, Inc. (NASDAQ: OCGN) announced the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to OCU410, an investigational AAV5-based subretinal gene therapy delivering RORA, for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). The RMAT designation was supported by Phase 2 data described as showing clinically meaningful efficacy and a favorable safety profile, with no drug-related serious adverse events reported. Ocugen said it reached alignment with the FDA in early July 2026 on the design of the OCU410 Phase 3 registrational trial, with initiation expected in Q3 2026, and anticipates a biologics license application (BLA) filing in 2028. The release also notes OCU410 previously received Advanced Therapy Medicinal Product (ATMP) classification from the European Medicines Agency.