MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) announced progress in its Phase 1 clinical trial for OCU200, a novel biologic designed to treat diabetic macular edema (DME) and related eye conditions. Following a review by the Data and Safety Monitoring Board (DSMB), dosing in the second cohort has been approved after favorable safety data from the first group.
OCU200 is a fusion protein combining tumstatin and transferrin, administered as an intravitreal injection. The ongoing dose-escalation study evaluates its safety at increasing doses of 0.025 mg, 0.05 mg, and 0.1 mg, with patients receiving two doses six weeks apart and being monitored for up to six months.
“OCU200 is given intravitreally,” said Peter Chang, MD, FACS, Co-President and Partner at MERSI. “No serious adverse events related to OCU200 have been reported to date.”
The results mark an encouraging step forward for OCU200, described as having a “very favorable safety and tolerability profile” by Dr. Huma Qamar, Ocugen’s Chief Medical Officer. She added, “There remains a considerable unmet medical need for the 30% to 40% of DME patients who do not respond to current anti-VEGF therapies. OCU200 holds the promise of potentially benefiting all DME, diabetic retinopathy (DR), and wet age-related macular degeneration (wet AMD) patients.”
Globally, over 130 million people are affected by DME, DR, and wet AMD. These conditions lead to progressive vision loss due to fluid buildup and damage in the retina. OCU200’s unique mechanism of action targets integrin receptors on endothelial cells, addressing the underlying causes of vascular damage in these diseases.
The ongoing trial underscores Ocugen’s commitment to advancing breakthrough therapies for significant unmet medical needs in ophthalmology.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.