Ocugen Receives Bahamas Regulator Provisional Approval For OCU400 Has Been Granted Approval And Priority Designation; The Company Will Supply OCU400 Through An EAP, With Goal Of Treating First RP Patient Within 90 Days
Ocugen will provide its investigational modifier gene therapy OCU400 through an expanded access program (EAP), with the goal of enabling the first patient to be treated for retinitis pigmentosa (RP) within 90 days, following full approval by the Longevity and Regenerative Therapies Board (LARTA Board)
In partnership with the LARTA Board, Ocugen intends to address global access and unmet need through commercial pricing evidenced with cost-effectiveness for a one-time broad treatment of RP
A novel modifier gene therapy for RP, OCU400 is advancing through Phase 3, with topline data expected in 1Q 2027 and a Biologics License Application submission planned for 2Q 2027
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