GlobeNewswire·Jul 29, 2026, 7:01 AM ET

Ocugen Announces that the U.S. Food and Drug Administration Has Granted OCU410 Regenerative Medicine Advanced Therapy (RMAT) Designation for Treatment of Geographic Atrophy, Secondary to Dry Age-Related Macular Degeneration

Ocugen received RMAT designation from the FDA for its investigational product OCU410 to treat geographic atrophy secondary to dry age-related macular degeneration.
The designation aims to expedite development of OCU410, a one-time gene therapy, while differentiating it from current chronic administration therapies.
FDA support for the designation was based on Phase 2 clinical data showing meaningful efficacy, a favorable safety profile, & no drug-related serious adverse events.
Ocugen aligned with the FDA on Phase 3 trial design in early July 2026, with initiation expected in Q3 2026 & a Biologics License Application filing anticipated in 2028.
RMAT designation provides eligibility for Fast Track & Breakthrough Therapy benefits, including rolling BLA review & potential accelerated approval.
OCU410 is an AAV5-based gene therapy delivering RORA to regulate retinal homeostasis pathways & has received ATMP classification from the European Medicines Agency.
Geographic atrophy affects an estimated 2 to 3 million people in the U.S. & Europe, representing a significant unmet medical need for irreversible blindness treatments.