Ocugen Inc (OCGN) News & EventsOCGNOcugen Inc

Ocugen Doses First Patient in OCU410 Phase 3 Trial

Ocugen announced that the first patient was dosed in the global Phase 3 registrational trial of OCU410, its modifier gene therapy candidate for GA secondary to dry age-related macular degeneration. The company also highlighted the recent FDA RMAT designation for OCU410, which supports a potential accelerated development and review pathway for the program.

Ocugen's OCU410 Receives FDA RMAT Designation

Ocugen announced that the FDA has granted RMAT designation to Ocugen's investigational product OCU410 for the treatment of geographic atrophy, secondary to dry age-related macular degeneration.

Ocugen Signs License Agreement for OCU400 with Roots Pharmaceutical

Ocugen announced the signing of a binding term sheet to negotiate and enter into a license agreement with Roots Pharmaceutical, and its strategic partner Al-Dhow International, for the exclusive rights to OCU400, Ocugen's novel modifier gene therapy for Retinitis Pigmentosa, in the Middle East and North Africa region. Pursuant to the term sheet, under the license agreement, Ocugen is expected to receive upfront license fees and near-term development milestone payments totaling up to $4M. The company would be entitled to sales milestone payments up to $255M, in addition to a 22% royalty on net sales of OCU400 generated by Ocugen's partner. Additionally, Ocugen would manufacture commercial supply of OCU400 under the terms of a related supply agreement. Additional details will be available once the definitive agreement between the parties is executed, which is expected to occur within the next 90 days. Ocugen continues to advance OCU400 through its Phase 3 liMeliGhT clinical development with a topline readout expected in Q1 2027 and BLA submission to follow.