Ocugen Grants Celairis Exclusive OCU400 Rights in Australia, New Zealand and ASEAN

Ocugen granted Celairis Therapeutics exclusive rights to commercialize OCU400, its investigational gene therapy for retinitis pigmentosa, in Australia, New Zealand and ASEAN markets, in a deal worth up to $7.1 million in fees and milestones plus a 50% share of gross profits. Stock Titan reported the agreement on November 10, 2026.

How the Ocugen-Celairis License Is Structured

Under the agreement, Ocugen receives an upfront license fee and potential development and milestone payments totaling up to $7.1 million, including $6.1 million tied to the upfront payment and OCU400 top-line results expected in the first quarter of 2027. Ocugen also gets a high single-digit percentage royalty on net sales and 50% of gross profits from OCU400 net sales in the territory.

Celairis, a Sydney-based company focused on Australia, New Zealand, Taiwan and ASEAN, will handle regional regulatory submissions, market access and commercialization. The parties expect to enter a supply agreement under which Ocugen will manufacture and supply OCU400. The license covers a region with an estimated 725 million people, following potential OCU400 approval in the U.S.

OCU400 is an investigational modifier gene therapy for retinitis pigmentosa, a group of inherited retinal diseases that cause progressive vision loss and, in many cases, blindness. Ocugen said OCU400 has not been approved or registered and is not available for supply in any markets of the territory. The company is conducting the Phase 3 liMeliGhT trial, with topline data expected in the first quarter of 2027, followed by planned global regulatory submissions including a Biologics License Application in the U.S. and a Marketing Authorization Application in Europe.

"This agreement marks our third strategic regional partnership for OCU400, underscoring the growing momentum behind our global access strategy and bringing our potential one-time treatment gene therapy closer to patients around the world," said Dr. Shankar Musunuri, Ocugen's Chairman, Chief Executive Officer and Co-Founder.

Matt Zeller, Chief Executive Officer, Co-Founder and Managing Director of Celairis, said: "Ocugen is the kind of partner Celairis was built for: a late-stage program, a clear strategy for reaching patients globally, and a conviction we share that geography should not decide access to new medicines."

Ocugen's Earlier OCU400 Regional Deal

According to akta.pro company records, Ocugen signed a binding term sheet with Roots Pharmaceutical and Al-Dhow International Holding in July 2026 for an exclusive license of OCU400 in retinitis pigmentosa across the Middle East and North Africa region. That agreement was valued at up to $255 million in sales milestones plus a 22% royalty on net sales.

Ocugen's Path to Three Retinal Gene Therapy Filings

In September 2026, Ocugen outlined plans for three biologics license applications for retinal gene therapies: OCU400 for retinitis pigmentosa, OCU410ST for Stargardt disease and OCU410 for geographic atrophy, Yahoo reported. In August 2026, MarketBeat reported that Ocugen planned to file Biologics License Applications for its retinitis pigmentosa and Stargardt disease gene therapies in 2027, targeting regulatory approvals in the U.S., Europe and Japan.

When OCU400 Data and Filings Are Expected

Ocugen expects OCU400 top-line results from the Phase 3 liMeliGhT trial in the first quarter of 2027, followed by planned global regulatory submissions. Regulatory submissions in the Celairis territory are expected to follow.