Ocugen receives provisional authorization in Bahamas for OCU400

Ocugen has received provisional authorization and priority status from the Longevity and Regenerative Therapies Board (LARTA) in the Bahamas for its OCU400 candidate, intended to treat retinitis pigmentosa. This administrative milestone enables an expanded access program within the archipelago, allowing patients with this hereditary eye disease to access the therapy ahead of conventional commercial approval.

The company plans to treat its first patient within 90 days of receiving full authorization. Regarding its broader development timeline, Ocugen expects topline data from its Phase 3 trial for OCU400 in the first quarter of 2027, with plans to submit a registration application to the U.S. FDA in the second quarter of 2027.

Ocugen is also managing other pipeline assets, including OCU410ST, with results expected in the second quarter of 2027, and OCU410, which recently entered Phase 3 trials. The company reported having $100.1 million in cash at the end of the second quarter to support its operations.