Ocugen strikes eye disease gene therapy deal in MENA

Ocugen has signed a binding term sheet with Roots Pharmaceutical and its partner Al-Dhow International to license OCU400, Ocugen’s modifier gene therapy for retinitis pigmentosa, across the Middle East and North Africa.

The proposed deal has Ocugen collecting up to $4 million in upfront and near-term development milestones, up to $255 million in sales milestones, and a 22% royalty on net sales in the region. Ocugen will manufacture and supply OCU400 under a related agreement.

OCU400 is Ocugen's lead modifier gene therapy, built on a gene-agnostic approach meant to correct the broader network of genes implicated in retinitis pigmentosa — the leading cause of inherited vision loss globally — rather than targeting one mutation at a time. Ocugen believes the approach could serve a wider swath of the retinitis pigmentosa population regardless of genotype.

The program is still working through its pivotal phase 3 liMeliGhT trial in the U.S., with a topline readout expected in the first quarter of 2027 and a BLA filing to follow. The MENA agreement follows a similar licensing deal Ocugen struck for OCU400 in Korea earlier this year, part of a broader push to line up ex-U.S. commercial partners ahead of any U.S. approval.