OcuTerra Therapeutics moves forward with OTT166 eye drops in Phase 2 trial

OcuTerra Therapeutics, a clinical-stage ophthalmology company, announced the successful full enrollment in its Phase 2 DR:EAM (Diabetic Retinopathy: Early Active Management) clinical trial.

The trial aims to assess the safety and efficacy of the company’s OTT166 eye drops in adult patients diagnosed with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) with minimal vision loss.

The DR:EAM study is a multicenter, randomized, and double-masked clinical trial. It compares the outcomes from a high and low daily dose of topically applied OTT166 against a control group. 225 adult patients were enrolled and randomly assigned to receive either one of two doses of OTT166 or placed in one of the two control groups. OTT166 is a small molecule RGD integrin inhibitor, engineered purposefully to be delivered topically as an eye drop, targeting the retina with therapeutic concentrations.

The trial’s primary efficacy endpoints include the proportion of patients experiencing treatment-emergent adverse events (TEAEs) and those who show improvement of at least two steps from baseline in the Diabetic Retinopathy Severity Scale (DRSS) at 24 weeks.

“The full enrollment of the DR:EAM clinical trial marks a crucial step in the development of OTT166 as a topical therapeutic that could benefit millions of patients with DR and transform the standard of care for this potentially devastating condition,” stated Kerrie Brady, President and CEO of OcuTerra Therapeutics.

OTT166 is a novel, patented, potent, and selective small molecule RGD integrin inhibitor. It has been purpose-engineered to distribute to the retina in high concentrations following topical (eye drop) administration.