- Topline results from study expected in Q1 2024
- Nesvategrast is a novel small molecule, potential first-in-class selective RGD integrin inhibitor specifically engineered for ocular delivery
- Addresses critical need for non-invasive, more accessible therapy for millions of patients worldwide suffering from diabetic retinopathy, a progressive, vision-threatening eye disease
January 03, 2024 - BOSTON-- OcuTerra Therapeutics, Inc. (“OcuTerra”), a clinical stage ophthalmology company developing innovative drugs to treat ophthalmic diseases for which the current standard of care of “watch-and-wait” does not prevent or control the progression of disease, announced the completion of the last patient’s final visit in the Phase 2 DR:EAM (Diabetic Retinopathy: Early Active Management) clinical trial of nesvategrast (OTT166). Nesvategrast, OcuTerra’s novel, selective RGD integrin inhibitor delivered via eye drop, is being developed as a possible treatment for the millions of patients with diabetic retinopathy who currently have no active, non-invasive therapies approved for this potentially devastating disease.
“The final patient visit in OcuTerra’s Phase 2 DR:EAM clinical trial brings us one step closer to providing an acceptable, non-invasive, active treatment to patients with diabetic retinopathy who are not actively managed due to the invasive nature of approved therapies, namely injections and/or laser,” said David Tanzer, M.D., board-certified ophthalmologist and Chief Medical Officer of OcuTerra Therapeutics. “We are incredibly pleased that this study has been a smooth process from start to finish. I would like to thank all of the clinical trial site staff, investigators, and study participants for their support of our work, and I am proud of the amazing clinical team that has achieved this latest study milestone.”
Topline data for the DR:EAM study are expected in the first quarter of 2024. These data will show the percentage of patients that have a ≥2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) when treated with nesvategrast vs. placebo. The 24-week study enrolled 225 adult patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) with minimal vision loss.
“The forthcoming data from the DR:EAM trial represents a significant step forward in our mission. We look forward to reviewing the data from the DR:EAM clinical trial and sharing our insights on how nesvategrast could benefit millions of patients living with DR,” said Kerrie Brady, President and CEO of OcuTerra Therapeutics. “Nesvategrast epitomizes our commitment to patient-centric innovation. This achievement marks a significant advancement in the development of what could be the first non-invasive therapy for diabetic retinopathy, a condition that currently lacks proactive, patient-friendly treatment options. We are excited to begin planning the next phase of development for nesvategrast.”... OcuTerra Therapeutics' Press Release -
