Ocugen, a biotechnology company, announced positive safety data from the first cohort of its Phase 1 clinical trial for OCU200, a novel fusion protein designed to treat diabetic macular edema (DME). The Data and Safety Monitoring Board approved the trial’s progression to the second cohort after finding no serious adverse events related to OCU200. The trial is evaluating the safety and tolerability of three different doses of OCU200 administered via intravitreal injection.
This development is a crucial step for Ocugen and potentially for DME patients. A significant portion of DME patients don’t respond to current anti-VEGF treatments, creating a substantial need for alternative therapies. OCU200’s unique mechanism of action, targeting integrin receptors on active endothelial cells, offers a different approach and could expand treatment options for these individuals. The positive safety profile from the first cohort is encouraging, suggesting the treatment is well-tolerated and paving the way for further investigation of its efficacy.
The Phase 1 trial is a multicenter, open-label, dose-escalation study involving three cohorts receiving low (0.025 mg), medium (0.05 mg), and high (0.1 mg) doses of OCU200. Each participant receives two doses six weeks apart and is monitored for up to six months. OCU200 combines tumstatin, with anti-inflammatory and anti-VEGF properties, and transferrin, which targets the drug to the choroid and retina. This targeted approach could allow for effective treatment at lower doses compared to existing therapies.
The positive safety data from the first cohort strengthens the potential of OCU200 as a viable treatment option for DME, diabetic retinopathy, and wet age-related macular degeneration. Continued positive results could significantly impact the treatment landscape for these conditions, offering hope for patients who haven’t responded to current therapies. Ocugen anticipates completing the Phase 1 trial in the latter half of 2025 and will provide updates on safety and efficacy throughout the year. These forthcoming updates will be critical in determining the next steps for OCU200’s development and its potential to address the unmet needs of millions affected by these debilitating eye diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
