Ocugen announces FDA approval for enrollment in OCU400 Phase 1/2 trial

Ocugen announced that the FDA approved enrolling pediatric patients in the ongoing OCU400 Phase 1/2 trial. "This approval moves us one step closer in our efforts to bring OCU400, a novel gene-agnostic modifier gene therapy, to market as a potential life-changing treatment for children afflicted with inherited retinal diseases, such as RP and LCA," noted Arun Upadhyay, PhD, Ocugen’s Chief Scientific Officer. "This approval further demonstrates the consistent, positive, and timely progress we are making with the Phase 1/2 trial in adult patients. Since a significant number of individuals in the pediatric age group are diagnosed with RP and LCA, it is very important for us to cover this age group in our clinical trials." Enrollment of adult RP patients in the Phase 1/2 trial is complete-per protocol-and enrollment continues among patients with LCA. The Company plans to initiate the Phase 3 trial near the end of 2023.