Ocugen Bags DSMB Approval To Initiate Dosing in Phase 1/2 ArMaDa Trial

The biotechnology firm Ocugen, Inc., specializes in finding, creating, and bringing to market innovative gene and cell therapies as well as vaccines. Recently, the Data and Safety Monitoring Board (DSMB) for the phase 1/2 ArMaDa clinical trial of OCU410 met and gave the go-ahead to start dosing with the medium dose of OCU410 during the study's dose-escalation phase.

The phase 1/2 clinical trial to date has dosed three participants with geographic atrophy (GA). During the dose-escalation phase, three more individuals (Cohort 2) and three patients (Cohort 3) will receive doses of OCU410, one at a medium dose and one at a high dose, respectively.

“The DSMB has recommended moving forward to medium dose for dosing subjects with GA,” said Dr. Peter Chang, MD, FACS, DSMB chair for the OCU410 clinical trial. “No serious adverse events (SAEs) related to OCU410 have been reported to date. I believe that this marks a critical next step towards determining the optimal dosing regimen and an important milestone for the clinical development of OCU410.”

“The positive DSMB review for the first modifier gene therapy for GA significantly builds on the favorable safety and tolerability profile exhibited by OCU410,” said Huma Qamar, M.D., MPH, chief medical officer of Ocugen. “We are very enthusiastic about the potential of OCU410 as a one-time treatment for life with a single sub-retinal injection.”

Currently licensed GA treatments have severe limitations because they require many injections per year and only target one route that contributes to GA. OCU410 controls several disease-related processes, including lipid metabolism, inflammation, oxidative stress, and the membrane assault complex (complement).