Ocugen has executed a licensing agreement with Roots Pharmaceutical, and its strategic partner Al-Dhow International Holding, for the exclusive rights to OCU400, Ocugen's novel modifier gene therapy for the treatment of retinitis pigmentosa, in the Middle East and North Africa region.
Through deal, first revealed in July, Ocugen will receive an upfront license fee and potential initial development milestone payments of up to $4 million, as well as potential sales milestone payments of up to $255 million and royalties. Ocugen will manufacture the commercial supply of OCU400 under terms of a related supply 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.
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