Final Patient Visit Concludes in Nesvategrast Phase 2 Trial for Diabetic Retinopathy

OcuTerra Therapeutics, a clinical-stage company specializing in ophthalmology, has recently announced the completion of the final patient visit in its Phase 2 DR:EAM clinical trial for nesvategrast (OTT166). Nesvategrast is a groundbreaking small molecule that represents a potential first-in-class selective RGD integrin inhibitor, tailored for ocular administration. This development is significant as it targets the pressing need for a non-invasive and more accessible treatment for diabetic retinopathy, a progressive eye disease that poses a serious threat to vision and affects millions of patients globally.

The Phase 2 DR:EAM trial focuses on patients with diabetic retinopathy who lack approved non-invasive therapies for this disease. The trial's completion is a milestone that brings OcuTerra closer to offering an alternative to the current standard treatments, which are often invasive and include injections or laser procedures. David Tanzer, M.D., the Chief Medical Officer of OcuTerra, expressed gratitude to all involved in the trial and pride in the clinical team's achievement.

The trial's topline results are anticipated in the first quarter of 2024 and will reveal the proportion of patients who have experienced at least a two-step improvement on the Diabetic Retinopathy Severity Scale (DRSS) when treated with nesvategrast compared to a placebo. The 24-week study involved 225 adult patients with varying degrees of diabetic retinopathy, including moderately severe non-proliferative diabetic retinopathy (NPDR) and mild proliferative diabetic retinopathy (PDR) with minimal vision loss.

Kerrie Brady, President and CEO of OcuTerra Therapeutics, highlighted the importance of the forthcoming data from the DR:EAM trial, stating that it marks a significant advancement in developing the first non-invasive therapy for diabetic retinopathy. Nesvategrast is a testament to OcuTerra's commitment to patient-centric innovation, aiming to provide a proactive and patient-friendly treatment option for a condition that currently lacks such alternatives.

The DR:EAM clinical trial is a multicenter, randomized, double-masked study designed to evaluate the safety and efficacy of nesvategrast at high and low doses compared to a placebo. The primary goal is to measure the percentage of patients showing a significant improvement in the Diabetic Retinopathy Severity Scale (DRSS). Additional objectives include assessing the prevention of progression to vision-threatening events and the delay in the need for intravitreal injections or laser treatments.

Diabetic retinopathy is a prevalent condition, affecting nearly 10 million people in the US alone, and is the leading cause of vision loss among working-age adults. The standard care involves active surveillance until complications arise, at which point more invasive treatments become necessary.

Nesvategrast is an investigational drug with a unique profile, designed to distribute to the retina effectively after topical administration. Preclinical studies have shown that it selectively inhibits key RGD integrin subtypes, which are crucial in regulating cellular responses to growth factors implicated in diabetic retinopathy and other ocular diseases. Early clinical trials have demonstrated its tolerability and biological activity in patients with diabetic retinal disease.

OcuTerra Therapeutics is dedicated to developing innovative treatments for ophthalmic diseases where the current standard of care falls short in preventing or controlling disease progression. The company's lead candidate, nesvategrast, is poised to become an early, non-invasive intervention for diabetic retinopathy, a chronic and progressive condition that is a major cause of vision loss worldwide. OcuTerra aims to revolutionize patient care by providing transformative treatments that move beyond the current "watch-and-wait" approach, which often leads to more invasive and intensive therapies as the disease progresses.