第3期OCU400 liMeliGhT临床试验目前正在进行,目标是在2026年上半年提交BLA。 https://www.globenewswire.com/news-release/2025/01/13/3008252/0/en/Ocugen-Inc-Announces-Positive-2-Year-Data-Across-Multiple-Mutations-from-Phase-1-2-Clinical-Trial-of-OCU400-A-Novel-Modifier-Gene-Therapy-for-Retinitis-Pi...
“We are encouraged by the EMA’s recognition of OCU400 as the Phase 3 liMeliGhT clinical trial advances,” said Dr. Huma Qamar, Chief Medical Officer at Ocugen. “I look forward to working collaboratively with the EMA to address the unmet medical need that remains for nearly 98% of...
We report the safety and efficacy of OCU400 gene modifier therapy from the phase 1/2 clinical trial for NR2E3 and RHO associated RP (NCT05203939). Methods : The multicenter phase 1/2 open-label trial was a 3+3 dose escalation and dose expansion study. Participants included adults with ...
Ocugen, Inc. today announced that the Data Safety and Monitoring Board (DSMB) for the OCU400 clinical trial recently convened and established high dose as the maximum tolerable dose (MTD) in the dose-escalation phase of the study. Continued Po...
today announced that the Independent Data and Safety Monitoring Board (DSMB) for the OCU400 Phase 1/2 clinical trial completed a review of safety data for subjects enrolled in Cohort 2 and recommends proceeding to enroll subjects in Cohort 3. The Company expects to complete Cohort 3 e...