Ocugen received U.S. Food and Drug Administration (FDA) Regenerative Medicine Advanced Therapy (RMAT) designation for its gene therapy candidate, OCU410. The treatment targets geographic atrophy secondary to dry age-related macular degeneration, a primary cause of irreversible blindness.
The FDA granted RMAT status following positive Phase 2 clinical data. This designation provides the benefits of Fast Track and Breakthrough Therapy programs to accelerate the regulatory review process.
Ocugen is developing OCU410 as a one-time treatment. The company plans to initiate a Phase 3 trial in the third quarter of 2026. Ocugen targets a potential Biologics License Application filing in 2028.