OcuTerra Completes Enrollment in Phase 2 DR:EAM Trial of Topically Delivered OTT166 in Adults with Diabetic Retinopathy
OcuTerra Therapeutics announced full enrollment in the company’s phase 2 DR:EAM (Diabetic Retinopathy: Early Active Management) clinical trial evaluating topically delivered OTT166 eye drops in adult patients with moderately severe to severe nonproliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) with minimal vision loss.
“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,” Kerrie Brady, President and CEO of OcuTerra Therapeutics, said in a company news release. “With limited therapeutic options for the treatment of DR on the market, we recognize an immense need for a noninvasive, earlier intervention. I want to thank the OcuTerra team, the investigators across our 65 trial sites and of course, the patients who have played an essential role in our work.”
The DR:EAM study is a multicenter, randomized, double-masked clinical trial designed to assess the safety and efficacy of a high and low dose of daily topical administration of OTT166 versus vehicle. The trial enrolled 225 adult patients who were randomly assigned one of two doses of OTT166 or to one of two control groups receiving vehicle. OTT166 is a small molecule RGD integrin inhibitor delivered topically in the form of an eye drop and is purpose-engineered to distribute to the retina in therapeutic concentrations.
The primary efficacy endpoints for the trial are the proportion of patients with treatment-emergent adverse events (TEAEs), and the proportion of participants who have improved by ≥ 2 steps from baseline in Diabetic Retinopathy Severity Scale (DRSS), both at 24 weeks. More information about the DR:EAM clinical trial can be found at ClinicalTrials.gov.
About the DR:EAM Clinical Trial
DR:EAM is a multicenter, randomized, double-masked clinical trial designed to assess the safety and efficacy of a high and low dose of daily topical administration of OTT166 versus placebo for 24 weeks in 225 adult patients with moderately severe to severe NPDR or mild proliferative diabetic retinopathy with minimal vision loss. The primary efficacy endpoint of the clinical trial is the percentage of patients that have a 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS). Additional endpoints of the clinical trial include measuring the prevention of progression to vision-threatening complications, amount of delayed time to intravitreal injection and/or laser treatment, and exploratory imaging endpoints.