Ocugen Announces Data and Safety Monitoring Board Approves Enrollment in High Dose Cohort 3 in GARDian Study for Stargardt Disease

• Established Medium Dose as Safe and Tolerable Dose in Current OCU410ST Clinical Trial
• DSMB Determination to Proceed with High Dose Cohort Dosing

Excerpt from the Press Release:

MALVERN, Pa., June 21, 2024 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that the Data and Safety Monitoring Board (DSMB) for the OCU410ST GARDian clinical trial recently convened and approved to proceed with dosing the high dose of OCU410ST in the dose-escalation phase of the study. OCU410ST (AAV5-hRORA) is a modifier gene therapy candidate being developed for Stargardt disease. Stargardt disease affects approximately 100,000 people in the U.S. and Europe combined.

Six patients with Stargardt disease have been dosed in the Phase 1/2 clinical trial to date in the low dose cohort and medium dose cohort. An additional three patients will be dosed with the high dose in cohort 3.

“The DSMB has recommended moving forward to dose subsequent subjects with Stargardt disease at the targeted high dose,” said Dr. Peter Y. Chang, MD, FACS, DSMB Chair for the OCU410ST clinical trial. “No serious adverse events (SAEs) related to OCU410ST have been reported to date.

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