Ocugen Wins Provisional Bahamas Approval for Gene Therapy OCU400
Ocugen's OCU400 gene therapy received provisional approval in The Bahamas to treat retinitis pigmentosa, with the first patient targeted within 90 days.
Ocugen, Inc. announced Thursday that its investigational gene therapy OCU400 has received provisional approval and priority designation from the LARTA Board, the regulatory body overseeing longevity and regenerative therapies in the Commonwealth of The Bahamas, positioning the Malvern, Pennsylvania-based biotechnology firm to begin treating patients with retinitis pigmentosa in the region.
The approval comes under The Bahamas' Longevity and Regenerative Therapies Act, which established the LARTA Board as the governing authority for reviewing and greenighting advanced therapeutic programs. The priority designation signals regulators view OCU400 as addressing a significant unmet medical need for patients suffering from retinitis pigmentosa, a degenerative eye disease that progressively destroys light-sensitive cells in the retina and can lead to blindness.
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Ocugen plans to supply OCU400 through an expanded access program, commonly known as an EAP, which allows patients to receive investigational treatments outside of formal clinical trials under regulatory oversight. The company set a target of treating its first retinitis pigmentosa patient within 90 days, contingent on receiving full LARTA approval following the provisional designation.
The move marks a notable regulatory milestone for Ocugen, which trades on the Nasdaq exchange under the ticker OCGN and has positioned itself as a specialist in gene therapies aimed at combating blindness diseases. Provisional approvals of this nature can serve as an early commercial pathway in markets with emerging regenerative medicine frameworks, though they carry inherent regulatory risk until full approval is granted.
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