Ocugen receives FDA clearance for Phase 3 trial of gene therapy OCU400 for retinitis pigmentosa.
Ocugen, a biotech firm, announced U.S. FDA clearance for its IND amendment to start a Phase 3 clinical trial for OCU400, a gene therapy for retinitis pigmentosa (RP). This marks the first gene therapy in Phase 3 for a broad RP indication. The trial will have a 150-participant sample size, with each arm consisting of 75 gene agnostic and 75 RHO gene mutation participants.
April 08, 2024
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