Ocugen receives OCU400 priority designation in Bahamas

• Ocugen received provisional approval and priority designation in The Bahamas for OCU400, an investigational gene therapy for retinitis pigmentosa.
• The company plans to provide OCU400 through an expanded access program after full approval and aims to treat the first patient within 90 days.
• Ocugen said Phase 3 testing is ongoing, with topline data expected in the first quarter of 2027 and a planned BLA submission in the second quarter of 2027.

Ocugen (NASDAQ:OCGN) announced that OCU400 received provisional approval and priority designation in The Bahamas for the treatment of retinitis pigmentosa, an inherited eye disorder.

The designation comes while OCU400 remains in Phase 3 clinical testing, with Ocugen continuing its regulatory and development activities ahead of planned data and submission milestones.

Ocugen said it plans to supply OCU400 through an expanded access program and aims to treat the first patient within 90 days after receiving full approval from The Bahamas’ Longevity and Regenerative Therapies Board.

Ocugen is a biotechnology company developing gene therapies and other treatments for rare and underserved diseases, including ophthalmic conditions.

The company said it expects topline Phase 3 data for OCU400 in the first quarter of 2027 and plans to submit a Biologics License Application in the second quarter of 2027.