Ocugen gets provisional approval in Bahamas for RP gene therapy OCU400

Ocugen, Inc. (NASDAQ: OCGN) announced it has received provisional approval and priority designation from the Longevity and Regenerative Therapies Board (LARTA Board) in the Commonwealth of The Bahamas for its investigational gene therapy OCU400, intended to treat retinitis pigmentosa (RP).

The LARTA Board is the regulatory agency responsible for reviewing and approving longevity and regenerative therapy programs in The Bahamas. According to the company, the priority designation places OCU400 on a structured pathway of enhanced regulatory engagement designed to advance it toward full approval and patient access.

Ocugen said it plans to supply OCU400 through an expanded access program, with a goal of treating the first RP patient within 90 days following full LARTA approval. The company also stated it intends to address global access through commercial pricing it describes as cost-effective for a one-time treatment of RP.

"Our partnership marks an important milestone for Ocugen – creating a unique opportunity to provide global access through the Bahamas to OCU400 for people suffering from retinitis pigmentosa," said Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen.

OCU400 is a modifier gene therapy candidate currently in Phase 3 clinical trials. It targets a broad RP indication spanning early-to-late-stage disease and pediatric to adult patients, and is designed to address mutations caused by more than 100 genes. The therapy is based on a nuclear hormone receptor gene called NR2E3, which regulates functions within the retina including photoreceptor development and cell survival.

The U.S. Food and Drug Administration has granted OCU400 Regenerative Medicine Advanced Therapy and Orphan Drug designations. The European Medicines Agency has granted it Orphan Medicinal Product Designation.

Ocugen said topline Phase 3 data is expected in the first quarter of 2027, with a Biologics License Application submission planned for the second quarter of 2027.

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