Ocugen Inc ((OCGN)) announced an update on their ongoing clinical study.
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Ocugen Inc. is currently conducting a Phase 3 clinical study titled ‘A Phase 3, Multi-Center, Randomized Study to Assess The Efficacy, Safety and Tolerability of Subretinal OCU400 Gene Therapy for the Treatment of Retinitis Pigmentosa.’ The study aims to evaluate the effectiveness and safety of OCU400 gene therapy in patients with retinitis pigmentosa (RP), a genetic disorder that causes vision loss. This research is significant as it targets RP associated with RHO mutations and other mutations, potentially offering a new treatment avenue for this debilitating condition.
The intervention being tested is a genetic therapy known as OCU400-301, administered via sub-retinal injection. This therapy is designed to modify genetic expressions to treat RP, with the goal of preserving or improving vision in affected individuals.
The study follows an interventional design with a randomized, parallel assignment. It is a single-masked study, meaning the outcomes assessor is blinded to the treatment allocation. The primary purpose is treatment, focusing on assessing the therapeutic impact of the gene therapy.
The study began on April 9, 2024, and is currently recruiting participants. The last update was submitted on October 14, 2025. These dates are crucial as they indicate the study’s progress and current status, providing a timeline for potential results and further developments.
The market implications of this study are significant for Ocugen Inc., as successful results could enhance the company’s stock performance and attract investor interest. The gene therapy market is competitive, with several companies pursuing similar innovations, but positive outcomes from this study could position Ocugen as a leader in RP treatment.
The study is ongoing, with further details available on the ClinicalTrials portal.