Ocugen Gets FDA Nod To Start Expanded Access Program For Adults With Retinitis Pigmentosa

(RTTNews) - Ocugen, Inc. (OCGN) Monday said it received clearance form the Food and Drug Administration to start its expanded access program or EAP for the treatment of adults suffering from retinitis pigmentosa with the company's gene therapy product candidate OCU400.

Retinitis pigmentosa, caused by mutations in genes, is a group of rare eye diseases that can lead to loss of sight.

EAP allows patients with serious or life-threatening conditions to access treatments outside of a clinical trial that are not yet approved by the FDA.

A phase 3 study of OCU400 in retinitis pigmentosa patients is underway.

The company said it is on track for targeted Biologics License Application (BLA) and Marketing Authorisation Application (MAA) approval in 2026.