OcuTerra Therapeutics’ investigational eye drops failed to improve disease severity or progression in a phase 2 diabetic retinopathy trial, prompting the Boston-based biotech to look at strategic alternatives.
The double-masked phase 2 trial, dubbed DR:EAM for “Diabetic Retinopathy: Early Active Management,” assessed the safety and efficacy of a daily high and low dose of nesvategrast (OTT166), a selective small-molecule RGD integrin inhibitor administered as an eye drop. Nesvategrast is currently the only asset listed in OcuTerra’s pipeline.
The biotech pitted the investigational eye drop against placebo for 24 weeks among 225 adults with moderately severe to severe non-proliferative diabetic retinopathy (NPDR), an early stage of the disease, or mild proliferative diabetic retinopathy with minimal vision loss.
DR:EAM failed to hit the main efficacy goal: a statistically significant percentage of patients that had a greater than two-step improvement on an ophthalmologic disease severity scale known as the Diabetic Retinopathy Severity Scale (DRSS). The trial also missed a secondary endpoint, failing to show nesvategrast had significant impact on the progression of disease as measured by DRSS.
Another secondary endpoint—preventing the onset of vision threatening events stratified by level of disease severity at baseline—did show a statistically significant improvement in patients with DRSS level 47 and 53 (moderately severe and severe NPDR, respectively) by week 24. Data also found nesvategrast to be safe and well tolerated.
“We plan to review the full dataset from the DR:EAM study to evaluate the future of the nesvategrast program," OcuTerra CEO Kerrie Brady said in a March 14 release. The private biotech now plans to assess strategic alternatives, according to the release.
Diabetic retinopathy is caused by blood vessel damage in the retina and can lead to blindness. OcuTerra designed nesvategrast to be a noninvasive treatment option for preserving vision and preventing progression, according to the company’s website.