OcuTerra Fails Phase 2 DR:EAM Trial Evaluating Nesvategrast for Diabetic Retinopathy

OcuTerra Therapeutics announced topline results from its phase 2 DR:EAM (Diabetic Retinopathy: Early Active Management) clinical trial of nesvategrast (OTT166), a novel, selective RGD integrin inhibitor developed as an eye drop. The clinical trial did not meet its primary or key secondary efficacy endpoints. Nesvategrast was shown to be safe and well tolerated, meeting its primary safety endpoint.

OcuTerra plans to evaluate its strategic alternatives and will share additional details at a later date.

“We are disappointed that the topline data on nesvategrast from our phase 2 DR:EAM clinical trial did not demonstrate a statistically significant impact on severity or progression of diabetic retinopathy,” Kerrie Brady, CEO and President of OcuTerra, said in a company news release. “We plan to review the full dataset from the DR:EAM study to evaluate the future of the nesvategrast program. I want to wholeheartedly thank the patients and investigators who participated in the DR:EAM trial as well as the OcuTerra team for making this study possible.”

Topline data did show nesvategrast was safe and well tolerated. However, the data failed to demonstrate a statistically significant improvement on the diabetic retinopathy severity scale (DRSS) for patients treated with nesvategrast compared to the placebo group, the primary efficacy endpoint. Data also did not show nesvategrast to have significant impact on the progression of disease as measured by DRSS, a key secondary endpoint. However, analysis of the development of vision threatening events (VTEs), another key secondary endpoint, stratified by level of disease severity at baseline, demonstrated a statistically significant improvement in patients with DRSS level 47 and 53 (moderately severe, and severe non-proliferative diabetic retinopathy respectively) at baseline in preventing the onset of VTEs by week 24 (P=0.045).