by: Sydney M Crago
The Phase 1/2 study includes a dose-escalation phase of the study featuring 3 cohorts each one receiving either a low, medium, or high dose of OCU410.
The Data and Safety Monitoring Board (DSMB) for the Phase 1/2 ArMaDa clinical trial for OCU410 by Ocugen, Inc. recently convened and approved to proceed dosing with the medium dose of OCU410 in the dose-escalation phase of the study.1
In the Phase 1/2, 3 patients with geographic atrophy (GA) have been dosed to date. An additional 3 patients will be dosed with the medium dose (Cohort 2) and 3 patients with the high dose (Cohort 3) of OCU410 in the dose-escalation phase.1
According to the company, OCU410 uses an AAV delivery platform for the retinal delivery of the RORA gene. This gene plays an important role in lipid metabolism, reducing lipofuscin deposits and oxidative stress, demonstrates an anti-inflammatory role, and inhibits the complement system in in-vitro and in-vivo (animal model) studies. These different roles may allow OCU410 to target multiple pathways linked with dAMD pathophysiology. Ocugen is developing AAV-RORA as a one-time gene therapy for the treatment of GA.
Read more: https://www.modernretina.com/view/data-and-safety-monitoring-board-dsmb-for-ocugen-s-phase-1-2-armada-clinical-approves-medium-dose-of-ocu410
Source: Modern Retina