OcuTerra Therapeutics has reported that its Phase II DR:EAM clinical trial of selective RGD integrin inhibitor nesvategrast (OTT166) eye drops for patients with diabetic retinopathy (DR) failed to meet endpoints.
The trial was designed to evaluate the safety and efficacy of high and low dose of daily topical administration of nesvategrast compared to placebo for 24 weeks.
This multicentre, randomised, double-masked study involved 225 adults with moderate to severe non-proliferative DR (NPDR) or mild proliferative DR (PDR) with minimal vision loss.
The trial’s primary efficacy endpoint was the percentage of subjects achieving a two-step or greater improvement on the DR Severity Scale (DRSS).
Additional objectives included evaluating the prevention of progression to vision-threatening events, the delay in needing intravitreal injections or laser treatment, and exploratory imaging endpoints.
Findings showed that the trial did not meet its primary or key secondary efficacy endpoints.
In the trial, nesvategrast was found to be safe and well-tolerated, fulfilling its primary safety endpoint.
While the topline data confirmed the treatment's safety, it did not show a statistically significant improvement in DRSS scores for patients treated with nesvategrast compared to the placebo group.
The treatment also failed to significantly impact the progression of the disease as measured by DRSS.
Nevertheless, a sub-analysis revealed a statistically significant benefit in preventing the onset of vision-threatening events by week 24 in patients with moderately severe to severe NPDR at baseline.
OcuTerra CEO and president Kerrie Brady said: “We are disappointed that the topline data on nesvategrast from our Phase II DR:EAM clinical trial did not demonstrate a statistically significant impact on severity or progression of diabetic retinopathy.
“We plan to review the full dataset from the DR:EAM study to evaluate the future of the nesvategrast programme.”
Last July, the company completed subject enrolment in Phase II DR:EAM trial of OTT166 eye drops.
