MALVERN, Pa., July 13, 2026
Ocugen announced the signing of a binding term sheet with Roots Pharmaceutical and its strategic partner Al-Dhow International Holding to negotiate an exclusive licensing agreement for OCU400, the company’s investigational modifier gene therapy for Retinitis Pigmentosa (RP), across the Middle East and North Africa (MENA) region. Under the proposed agreement, Ocugen is eligible to receive up to $4 million in upfront licensing and near-term development milestone payments, as well as cumulative sales milestone payments of up to $255 million and 22% royalties on net sales. Ocugen will also manufacture and supply commercial OCU400 for the partnership. The agreement supports the company’s strategy to expand global access to its gene therapy platform while addressing significant unmet medical needs in inherited retinal diseases.
Strategic Partnership Expands Access to Gene Therapy in the MENA Region
Retinitis Pigmentosa remains one of the leading inherited causes of blindness worldwide and has a notable prevalence across countries in the Middle East and North Africa. Through this collaboration, Roots Pharmaceutical will obtain exclusive regional rights to commercialize OCU400, leveraging its established presence in rare disease markets throughout the region. The partnership is intended to improve patient access to a potential one-time gene therapy designed to treat RP, while strengthening Ocugen’s international commercialization strategy. The companies expect to finalize a definitive licensing agreement within the next 90 days.
OCU400 Continues Advancing Through Late-Stage Clinical Development
OCU400 is currently being evaluated in the Phase 3 liMeliGhT clinical trial for Retinitis Pigmentosa, with topline results anticipated during the first quarter of 2027, followed by a planned Biologics License Application (BLA) submission. Unlike conventional gene replacement therapies that target individual genetic mutations, OCU400 utilizes Ocugen’s proprietary modifier gene therapy platform, designed to regulate multiple gene networks involved in retinal degeneration. This gene-agnostic approach has the potential to benefit a broader patient population affected by inherited retinal diseases, regardless of the specific genetic mutation responsible for disease progression.
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Ocugen Strengthens Global Commercialization Strategy for OCU400
The proposed licensing agreement represents another milestone in Ocugen’s broader effort to establish regional partnerships that accelerate global access to its ophthalmology pipeline. By combining Ocugen’s gene therapy development and manufacturing capabilities with Roots Pharmaceutical’s commercial infrastructure throughout the MENA region, the collaboration aims to support future regulatory approvals and commercialization of OCU400. If successfully completed, the partnership could expand treatment options for patients living with Retinitis Pigmentosa while reinforcing Ocugen’s position as a developer of innovative gene therapies targeting blindness and inherited retinal disorders.
Source: Ocugen, press release
