OcuTerra marks last patient’s final visit in Phase 2 DR:EAM study of Nesvategrast for DR

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OcuTerra Therapeutics, Inc. has completed the last patient’s final visit in the Phase 2 DR:EAM (Diabetic Retinopathy: Early Active Management) clinical trial of nesvategrast (OTT166). Nesvategrast is OcuTerra’s novel, selective RGD integrin inhibitor delivered via eye drop and is being developed as a possible treatment for patients with diabetic retinopathy (DR).

In the press release, David Tanzer, MD, a board-certified ophthalmologist and Chief Medical Officer of OcuTerra Therapeutics thanked those who have helped the company to reach this milestone and noted how this non-invasive treatment could impact the future treatment of diabetic retinopathy. He is quoted as saying, “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. 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.”

The company expects to share 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.

Kerrie Brady, President and CEO of OcuTerra Therapeutics noted the importance of this next step, saying, “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. 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.”

Reference:

1. OcuTerra Therapeutics Announces Last Patient Completes Final Visit in Nesvategrast (OTT166) Eye Drop Phase 2 DR:EAM Clinical Trial in Diabetic Retinopathy. OcuTerra Therapeutics Inc. January 3, 2024. Accessed January 4, 2024. https://www.biospace.com/article/releases/ocuterra-therapeutics-announces-last-patient-completes-final-visit-in-nesvategrast-ott166-eye-drop-phase-2-dr-eam-clinical-trial-in-diabetic-retinopathy/