Ocugen gets FDA nod to begin expanded access program for OCU400 in retinitis pigmentosa

Ocugen, Inc.

FDA approved expanded access program for OCU400 for adult RP patients 18+ with minimal retinal preservation.
OCU400 is a modifier gene therapy; positive Phase 1/2 data and ongoing Phase 3 liMeliGhT trial.
RP affects ~300,000 in US/Europe, 1.6M globally; EAP provides access before BLA approval.
Targets BLA and MAA approval in 2026; OCU400 has orphan drug and RMAT designations from FDA.

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