MALVERN, PA — Ocugen, Inc. (NASDAQ: OCGN) this week announced the dosing of the first patient in its Phase 1 clinical trial for OCU200, a potential treatment for diabetic macular edema (DME).
The ongoing study is an open-label, multicenter trial designed to evaluate the safety of OCU200, delivered through intravitreal injections in low, medium, and high doses. Each participant will receive two injections six weeks apart, with follow-up extending three months after the final dose.
“OCU200 has the potential to change the treatment landscape for DME, diabetic retinopathy, and wet age-related macular degeneration,” said Dr. Shankar Musunuri, Ocugen’s CEO and Co-Founder. He highlighted the drug’s unique mechanism of action, which targets key integrin receptors, and its promise for patients who do not respond to current anti-VEGF therapies.
OCU200 is a recombinant fusion protein that combines anti-inflammatory and anti-VEGF properties. By targeting the retina and choroid with precision, the therapy aims to address vascular permeability, inflammation, and neovascularization, core contributors to vision loss in conditions like DME.
Globally, more than 130 million people are affected by DME, diabetic retinopathy, or wet AMD, all of which can lead to progressive vision loss. With current treatments failing to meet the needs of up to 40% of patients, Ocugen sees OCU200 as a potential first-line therapy to address unmet medical needs.
Dr. Huma Qamar, Chief Medical Officer at Ocugen, expressed optimism about advancing clinical trials and generating both safety and early efficacy data. “OCU200 brings an innovative biologic candidate to our ophthalmology portfolio targeting blindness diseases,” she said.
The trial marks a significant step forward in developing novel therapies for vision-threatening conditions.
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