July 13, 2026 —
Ocugen announced that it has signed a binding term sheet to negotiate and enter into a license agreement with Roots Pharmaceutical and its strategic partner Al-Dhow International Holding for exclusive rights to OCU400 in the Middle East and North Africa, or MENA, region.
OCU400 is Ocugen’s investigational AAV-based modifier gene therapy for retinitis pigmentosa, or RP, a leading cause of inherited vision loss. The therapy is being developed as a potential one-time treatment for RP, a disease with significant unmet need and notable prevalence across the MENA region.
Under the expected license agreement, Ocugen would receive upfront license fees and near-term development milestone payments totaling up to $4 million. The company would also be eligible for up to $255 million in cumulative sales milestone payments, along with royalties equal to 22% of net sales of OCU400 generated by its partner.
Ocugen would retain responsibility for manufacturing and commercial supply of OCU400 under a related supply agreement. Additional terms are expected to be finalized once the definitive agreement is executed, which the companies expect to occur within the next 90 days.
The regional partnership is part of Ocugen’s broader strategy to expand access to its AAV gene therapy platform through geographic collaborations. By partnering with Roots Pharmaceutical and Al-Dhow International Holding, Ocugen aims to support future commercialization in a region where inherited retinal diseases remain a major unmet medical need.
OCU400 is currently being evaluated in Ocugen’s Phase 3 liMeliGhT clinical trial. The company expects a topline readout in the first quarter of 2027, followed by a potential Biologics License Application submission.
The agreement adds commercial momentum to OCU400 as it advances through late-stage development. If successful, the program could provide a differentiated AAV-based retinal gene therapy option for patients with retinitis pigmentosa, while the MENA partnership may help establish a pathway for regional access following regulatory progress.
