Ocugen, Inc. has announced the first patient dosed in its Phase 1 clinical trial of OCU200 for diabetic macular edema (DME). The trial, a multicenter, open-label, dose-escalation study, is designed to assess the safety of OCU200 administered via intravitreal injection.
The Phase 1 trial includes three cohorts receiving low (0.025 mg), medium (0.05 mg), and high (0.1 mg) doses. Participants will receive two intravitreal injections of OCU200 six weeks apart, with follow-up continuing for three months after the last injection.
OCU200: A Novel Approach to DME Treatment
OCU200 is a recombinant fusion protein comprised of tumstatin, an anti-inflammatory and anti-VEGF agent that binds to integrin receptors, and transferrin, which targets the drug to the choroid and retina. This mechanism of action aims to reduce vascular permeability, inflammation, and neovascularization, key factors in the pathophysiology of DME, diabetic retinopathy (DR), and wet age-related macular degeneration (wet AMD).
According to Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen, OCU200 has the potential to change the treatment landscape for DME, DR, and wet AMD due to its unique mechanism. He noted that OCU200 holds promise for all DME patients, including the 30-40% who do not respond to current anti-VEGF therapies.
Addressing Unmet Needs in DME Treatment
Approximately 12 million people in the United States and 130 million people worldwide are affected by DME, DR, or wet AMD. These conditions share common symptoms, including blurred vision and progressive vision loss, resulting from fluid accumulation caused by fragile and leaky new blood vessels in the retina.
Dr. David Almedia, Vitreoretinal Surgeon and Clinician Scientist, President and CEO of Erie Retina Research, and Founder and President of Case X Global, stated that there remains a considerable unmet medical need for DME and DR patients with currently available anti-VEGF treatments. He expressed eagerness to provide a new therapeutic option to these patients.
Future Development Plans
Ocugen intends to pursue approval to use OCU200 as a first-line therapy for DME, DR, and wet AMD. Dr. Huma Qamar, Chief Medical Officer at Ocugen, expressed enthusiasm about the trial and the potential to share safety and preliminary efficacy data as the study progresses. She added that OCU200 brings an innovative biologic candidate to Ocugen’s ophthalmology portfolio targeting blindness diseases.
