Diabetic retinopathy eye drop trial fails to meet primary efficacy endpoint

Key Takeaways

  • The phase 2 DR:EAM clinical trial investigating nesvategrast eye drops for the treatment of diabetic retinopathy did not meet the endpoint of the percentage of patients with a two-step or greater improvement in Diabetic Retinopathy Severity Score (DRSS).
  • Nesvategrast was safe and well tolerated.

OcuTerra Therapeutics is evaluating strategic alternatives after the phase 2 DR:EAM trial failed to meet its primary efficacy endpoint, according to a press release. The trial investigated the use of nesvategrast (OTT166 5%) eye drops in patients with diabetic retinopathy. Trial data showed that nesvategrast was safe and well tolerated. However, it failed to meet the primary efficacy endpoint of the percentage of patients with a two-step or greater improvement in Diabetic Retinopathy Severity Scale (DRSS), a 12-step standardized scale that classifies diabetic retinopathy severity, as well as the secondary endpoint of impact on the progression of disease as measured by DRSS.

“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 the release. “We plan to review the full data set from the DR:EAM study to evaluate the future of the nesvategrast program.”

Source: Healio Ocular Surgery News, March 15, 2024; see source article