Ocugen wins provisional approval for OCU400 in Bahamas under LARTA pathway
OCGN•Ocugen received provisional approval and priority designation in The Bahamas for OCU400, with first expanded-access patient dosing targeted within 90 days of full approval and Phase 3 topline data expected in 1Q 2027.
1. Approval and trial timeline
The Bahamas’ LARTA Board granted provisional approval and priority designation to Ocugen’s OCU400 modifier gene therapy for retinitis pigmentosa, placing the program on an expedited pathway toward full approval. Ocugen plans to supply the therapy through expanded access and is targeting first patient dosing within 90 days of full approval; OCU400 remains in Phase 3, with topline data expected in 1Q 2027.
