RegulatoryCompany release

Ocugen's OCU400 wins provisional Bahamas approval for early access; Phase 3 data due 1Q 2027

🇺🇸 Ocugen, Inc. (OCGN) · Wed 04 Nov 2026

The Bahamian regulator has granted provisional approval and priority designation to the retinitis pigmentosa gene therapy, as Ocugen reports full Phase 3 enrolment and a BLA target of 2Q 2027.

Ocugen has said that the Bahamas regulator, LARTA, granted provisional approval and priority designation to OCU400, its gene therapy for retinitis pigmentosa. The approval covers a regulated early access programme, according to the company's third-quarter 2026 business update.

Ocugen said the programme could begin enrolling patients by the end of the year. It cited potential commercial pricing of $1–2m per patient. The update did not provide further detail here on programme design, eligibility or how the pricing would operate.

On the main development path, Ocugen reported that enrolment is complete in the Phase 3 liMeliGhT trial of OCU400, with 140 patients. Topline data are expected in the first quarter of 2027, and the company is targeting a Biologics License Application (BLA) submission in the second quarter of 2027.

The company also gave updates on two other candidates. Enrolment is complete in the Phase 2/3 trial of OCU410ST in Stargardt disease, with a BLA targeted for mid-2027. The first patient has been dosed in the Phase 3 trial of OCU410 in geographic atrophy.

What it means for your team

  • Early access arrangements in smaller jurisdictions can run ahead of major-market approvals. Regulatory teams should note that such provisional approvals are not equivalent to FDA or EMA authorisation.
  • Any patients treated in the Bahamas programme could generate real-world safety information for a gene therapy. Pharmacovigilance teams should watch how that data is collected and reported.
  • Payers and market-access teams will see a stated price range of $1–2m per patient as an early reference point, though it is described only as potential commercial pricing.
  • The Phase 3 readout in 1Q 2027 and the targeted 2Q 2027 BLA are the next milestones for the retinitis pigmentosa programme.

Company's press release (SEC filing): Ocugen, Inc. ↗

Article written by VigiEye from the official source (Ocugen, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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