Ocugen Wins Bahamas Provisional Approval for Gene Therapy OCU400
Ocugen's OCU400 gene therapy received provisional approval in The Bahamas to treat retinitis pigmentosa, with first patient treatment targeted within 90 days.
Ocugen, Inc. announced Thursday that its gene therapy candidate OCU400 has received provisional approval and priority designation from the LARTA Board, the regulatory body overseeing longevity and regenerative therapy programs in the Commonwealth of The Bahamas, positioning the Malvern, Pennsylvania-based biotechnology firm to begin treating patients with retinitis pigmentosa in the island nation.
The approval was granted under the Longevity and Regenerative Therapies Act, a Bahamian regulatory framework designed to fast-track access to advanced regenerative medicines. The LARTA Board's priority designation signals that OCU400 was deemed to address a significant unmet medical need within its jurisdiction.
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Ocugen said it plans to supply OCU400 through an expanded access program, commonly known as a compassionate use pathway, with a stated goal of treating the first retinitis pigmentosa patient within 90 days of receiving full LARTA approval. The provisional designation effectively clears an initial regulatory hurdle while final approval proceedings continue.
Retinitis pigmentosa is a degenerative eye disease that progressively damages the retina and can lead to severe vision loss or blindness. Ocugen has positioned OCU400 as a potential gene therapy intervention targeting the condition, which currently has limited treatment options available to patients globally.
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