Ocugen Wins Bahamas Approval for Gene Therapy Targeting Blindness
Ocugen's OCU400 gene therapy received provisional approval in The Bahamas, with the company aiming to treat its first retinitis pigmentosa patient within 90 days.
Ocugen, Inc. announced Thursday that its OCU400 gene therapy 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. The Malvern, Pennsylvania-based biotechnology company trades on the Nasdaq under the ticker OCGN.
The LARTA designation positions OCU400 as a priority candidate under The Bahamas' Longevity and Regenerative Therapies Act, a regulatory framework specifically designed to evaluate and approve advanced regenerative medicine programs. The provisional approval allows Ocugen to move forward with patient access before full regulatory clearance is granted.
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Ocugen plans to supply OCU400 through an Expanded Access Program, commonly referred to as an EAP. The company has set a target of treating its first retinitis pigmentosa patient within 90 days of receiving full LARTA approval, reflecting an accelerated timeline that underscores the therapy's priority standing.
Retinitis pigmentosa is a group of inherited eye disorders that cause progressive damage to the retina, leading to significant vision loss and, in many cases, complete blindness. Gene therapies like OCU400 represent a frontier approach aimed at addressing the underlying genetic causes of such conditions rather than managing symptoms alone. Ocugen describes itself as a pioneering biotechnology leader in gene therapies for blindness diseases.
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