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Ocugen, Inc. Announces Health Canada Approval to Initiate Phase 3 Clinical Trial for OCU400 – Modifier Gene Therapy for Broad Retinitis Pigmentosa Indication
Ocugen (NASDAQ: OCGN) has received approval from Health Canada to initiate a Phase 3 clinical trial for OCU400, its modifier gene therapy for retinitis pigmentosa (RP). The trial, named liMeliGhT, will run parallel to the U.S. FDA trial, potentially expediting a gene-agnostic treatment option for approximately 110,000 patients in the U.S. and Canada.
The study will enroll up to 50 subjects across 5 Canadian sites, targeting patients aged 8 and older with various stages of RP.
The primary endpoint is the change in functional vision measured by the Luminance Dependent Navigation Assessment (LDNA). OCU400 has received orphan drug and RMAT designations from the FDA, with 2026 BLA and MAA approval targets.
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