Vantage Biosciences has initiated a Phase 2 clinical trial of VX-01, an oral therapy for non-proliferative diabetic retinopathy (NPDR). This trial is evaluating VX-01’s potential as the first oral treatment for NPDR, targeting the inflammatory mechanisms driving the disease’s progression. Diabetic retinopathy affects over 100 million people globally and is a leading cause of blindness in working-age adults, underscoring the need for effective early interventions.
This Phase 2 trial represents a substantial advancement in addressing the significant unmet medical need for NPDR treatment. Current treatment options for later stages of diabetic retinopathy can be invasive, highlighting the potential of VX-01 as an earlier, less invasive intervention. Successful development of an oral therapy could dramatically improve patient care and reduce the overall burden of this widespread disease. Early intervention could help preserve vision for millions and potentially lessen the long-term healthcare costs associated with managing advanced diabetic eye diseases.
The Phase 2 study is a double-masked, randomized, placebo-controlled trial involving patients with moderate to severe NPDR without center-involved diabetic macular edema. Participants will receive either VX-01 or a placebo twice daily for 52 weeks, followed by a 12-week observation period. The trial is being conducted across 27 sites in the US, Australia, and several Southeast Asian countries, with results anticipated in 2027. VX-01 is a small molecule designed to target the neurovascular inflammation linked to diabetic eye disease. By addressing these underlying mechanisms, VX-01 aims to slow or halt disease progression before irreversible vision loss occurs.
Positive results from this Phase 2 trial would be a significant catalyst for Vantage Biosciences. It could pave the way for further clinical development, ultimately leading to a new, readily accessible treatment option for NPDR. This could reshape the landscape of diabetic eye disease management, offering a more convenient and potentially preventative approach for millions of patients. Furthermore, positive clinical data would strengthen Vantage Biosciences’ position in the ophthalmology market and attract further investment and partnerships.
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.