Ocugen OCU400 development and licensing

Ocugen is advancing its gene therapy candidate, OCU400, which is designed to treat retinitis pigmentosa. In September 2026, the company received provisional authorization and priority status from the Longevity and Regenerative Therapies Board (LARTA) in the Bahamas. This milestone allows for an expanded access program for patients in the archipelago prior to full commercial approval.

By October 2026, Ocugen expanded its commercial reach by entering a licensing agreement for the Middle East and North Africa regions with Roots Pharmaceutical and Al-Dhow International Holding. This deal includes upfront payments and potential milestone payments totaling up to $255 million, alongside a 22 percent royalty on net sales.

Regarding its clinical and regulatory timeline, Ocugen expects to report topline data from its Phase 3 trial for OCU400 in the first quarter of 2027, with plans to submit a Biologics License Application to the U.S. FDA in the second quarter of 2027. To support ongoing clinical studies, the company has also considered a capital increase through the authorization of additional common shares.