Ocugen plans expanded access for OCU400 in The Bahamas after provisional approval

  • Ocugen plans to supply OCU400 through an expanded access program in The Bahamas.
  • The company aims to treat the first patient within 90 days after full LARTA approval.
  • OCU400 is in Phase 3 and holds RMAT, ODD, and OMPD designations.

Ocugen said it received provisional approval and priority designation from The Bahamas’ Longevity and Regenerative Therapies Board for OCU400, its investigational modifier gene therapy for retinitis pigmentosa. The company plans to supply OCU400 through an expanded access program, with the goal of treating the first patient within 90 days after full approval. OCU400 is in Phase 3 development for a broad retinitis pigmentosa population, with topline data expected in the first quarter of 2027 and a Biologics License Application planned for the second quarter. The therapy is designed to address disease biology across mutations in more than 100 genes and has received RMAT and Orphan Drug designations from the U.S. Food and Drug Administration, as well as Orphan Medicinal Product Designation from the European Medicines Agency.

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