OcuTerra Therapeutics, Inc. (“OcuTerra”), a clinical stage ophthalmology company developing innovative drugs to treat ophthalmic diseases, today 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 (OTT166 5%) 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,” said Kerrie Brady, CEO and president of OcuTerra. “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).
“OcuTerra’s work is based on scientific rigor and commitment to identifying the best possible opportunity to improve the lives of patients living with serious ophthalmic diseases,” said David Tanzer, MD, chief medical officer of OcuTerra Therapeutics. “While our phase 2 topline data did not show the efficacy we had hoped, we had advanced the program with substantial preclinical and clinical data and will use learnings to help inform the ophthalmic community and their future work.”
About the DR:EAM Clinical Trial
DR:EAM is a multicenter, randomized, double-masked clinical trial designed to assess the safety and efficacy of a high and low dose of daily topical administration of nesvategrast (OTT166) versus placebo for 24 weeks in 225 adult patients with moderately severe to severe NPDR or mild PDR with minimal vision loss.
The primary efficacy endpoint of the clinical trial is the percentage of patients that have a ≥2-step improvement in the diabetic retinopathy Severity Scale (DRSS). Additional endpoints of the clinical trial include measuring the prevention of progression to vision-threatening events, amount of delayed time to intravitreal injection and/or laser treatment, and exploratory imaging endpoints. More information about this trial is available at ClinicalTrials.gov.