Ocugen receives provisional Bahamas clearance for OCU400 access pathway

Ocugen ($OCGN) received provisional approval and priority designation from the Bahamas’ Longevity and Regenerative Therapies Board for OCU400, its experimental gene therapy for retinitis pigmentosa. The company intends to supply the treatment through an expanded-access program, with the goal of treating an initial patient within 90 days after full approval from that regulator.

The provisional decision creates a pathway toward local access; it is not the final authorization required to start the program and is not an FDA approval. OCU400 remains in Phase 3 development, with topline results expected in the first quarter of 2027 and a US biologics application planned for the second quarter. Those trial and filing milestones remain prospective rather than completed.

Sources:

• Ocugen — provisional Bahamas decision, GlobeNewswire release