Phase 2 DR:EAM Trial Results: Nesvategrast for Diabetic Retinopathy

OcuTerra Therapeutics, a company focused on developing treatments for ophthalmic diseases, has reported the results of its Phase 2 clinical trial for nesvategrast (OTT166), an eye drop medication intended to treat diabetic retinopathy. The trial, known as DR:EAM, did not achieve its primary or key secondary efficacy goals, though the drug proved to be safe and well tolerated by patients.

The primary objective of the DR:EAM trial was to assess the impact of nesvategrast on the severity and progression of diabetic retinopathy. Despite this setback, the company has noted a statistically significant improvement in preventing vision-threatening events in patients with certain levels of disease severity at the start of the trial.

Kerrie Brady, CEO of OcuTerra, expressed disappointment over the trial's outcomes but emphasized the importance of reviewing the full data set to consider the future of the nesvategrast program. The company is now exploring strategic options and will provide further updates in due course.

The DR:EAM trial was a randomized, double-masked study involving 225 adult patients with varying degrees of diabetic retinopathy. It aimed to evaluate the safety and efficacy of nesvategrast in comparison to a placebo. The trial's primary efficacy endpoint was the proportion of patients showing a significant improvement on the Diabetic Retinopathy Severity Scale (DRSS).

Diabetic retinopathy is a prevalent condition, affecting nearly 10 million people in the United States and is a leading cause of vision loss among working-age adults. The standard treatment involves monitoring and waiting for sight-threatening complications before administering more invasive procedures.

Nesvategrast is a novel, patented small molecule that inhibits RGD integrins, which are implicated in the development and progression of diabetic retinopathy. Preclinical and early clinical trials have shown that the drug can be distributed to the retina in high concentrations when administered as an eye drop.

OcuTerra Therapeutics is committed to developing innovative treatments for ophthalmic diseases where current care does not effectively manage early disease progression. The company's goal is to offer transformative treatments for patients and healthcare providers who are currently limited to monitoring the disease as it progresses to a point where more intensive and invasive therapies are required.

The company's focus on scientific rigor and dedication to improving patient outcomes, as stated by David Tanzer, M.D., Chief Medical Officer, will guide future efforts in the ophthalmic field, despite the recent trial's results.