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Ocugen licenses OCU400 retinitis pigmentosa gene therapy to Celairis for Australia, NZ and ASEAN

🇺🇸 Ocugen, Inc. (OCGN) · Tue 10 Nov 2026

Ocugen has granted Sydney-based Celairis exclusive regional rights to its investigational modifier gene therapy, with Phase 3 top-line data expected in the first quarter of 2027.

Ocugen and Sydney-based Celairis Therapeutics announced on 10 November 2026 an exclusive licence for OCU400, an investigational modifier gene therapy for retinitis pigmentosa. The agreement covers Australia, New Zealand and the markets of the Association of Southeast Asian Nations (ASEAN).

Under the terms, Ocugen will receive an upfront fee and up to $7.1 million in development and milestone payments. It will also receive a high single-digit royalty and 50% of gross profits. The summary of the announcement does not state the size of the upfront fee.

Celairis will be responsible for regulatory filings, market access and commercialisation across the licensed territory. That places the regional dossier work, and any engagement with national authorities, with the Sydney company rather than with Ocugen.

OCU400 is not approved anywhere in the territory. Phase 3 top-line data are expected in the first quarter of 2027, and regional submissions are due to follow that readout.

What it means for your team

  • Regulatory teams tracking ophthalmic gene therapies in Australia, New Zealand and ASEAN should expect Celairis to be the regional filing party, with submissions following the Phase 3 data expected in Q1 2027.
  • Market-access teams should note that no approval exists in the territory, so pricing and reimbursement planning is at a very early stage.
  • The profit-sharing and royalty structure shows a licensing model in which the originator retains a substantial share of regional economics while a local partner carries commercial execution.

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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