Ocugen 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. "The DSMB has recommended moving forward to dose subsequent subjects with NR2E3 and RHO gene mutations associated with Retinitis Pigmentosa and CEP290 gene mutations associated with Leber Congenital Amaurosis at the targeted dose in the expansion phase of the study," said Dr. Peter Chang, MD, FACS, Massachusetts Eye Research & Surgery Institution, DSMB Chair for the OCU400 clinical trial. "No serious adverse events related to OCU400 have been reported to date." 10 patients with NR2E3 and RHO gene mutations associated with RP have been dosed in the Phase 1/2 clinical trial to date. An additional eight patients with these RP gene mutations, along with three patients with CEP290 gene mutations associated with LCA, will be dosed at MTD and enrollment is expected to be complete by the end of Q1 2023. Data from the MTD has the potential to navigate strategy for the planned Phase 3 study in the U.S. and other major markets. The Company plans to file a Biologics License Application for OCU400 in 2025.
Published first on TheFly
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