Ocugen doses first patient in OCU410 Phase 3; OCU410ST interim shows negative treatment effect

Ocugen, Inc.

First patient dosed in global Phase 3 registrational trial of OCU410 (AAV5-hRORA) for geographic atrophy secondary to dry AMD.
FDA granted RMAT designation for OCU410 in July 2026; CBER EOP2 aligned on endpoints, dose, adaptive design, single pivotal BLA path.
OCU410ST DMC interim (26 subjects: 16 treated, 10 control) at 8 months showed negative direction of treatment effect; futility noted.
DMC recommended obtaining 8-month follow-up of entire population despite baseline lesion size imbalance in interim sample.
Company will follow DMC recommendation to continue OCU410ST study per existing protocol.

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