BOSTON–(BUSINESS WIRE)–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, today 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.”
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 nesvategrast (OTT166) versus placebo for 24 weeks in 225 adult patients with moderately severe to severe NPDR or mild PDR 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 events, amount of delayed time to intravitreal injection and/or laser treatment, and exploratory imaging endpoints. More information about this trial is available at ClinicalTrials.gov.
About Diabetic Retinopathy
Diabetic retinopathy is the most common diabetic eye disease and the leading cause of vision loss and blindness in American working age adults, which affects nearly 10 million people in the US1. The current standard of care for diabetic retinopathy is active surveillance or “watch-and-wait”2 until a sight threatening complication arises. When vision deteriorates further due to complications, the patient must undergo injections of medication directly into the back of their eye (intravitreal injection) or undergo destructive laser procedures to help stop the growth of new blood vessels and decrease fluid buildup.
Nesvategrast (OTT166) is an investigational, novel, patented, potent and selective small molecule RGD integrin inhibitor designed with purpose engineering to have an optimum balance of physiochemical properties to allow it to distribute to the retina in high concentrations after topical (eye drop) administration to the eye. In preclinical studies, nesvategrast selectively inhibited key RGD integrin subtypes, including αvβ3, to regulate cellular responses to VEGF and other growth factors known to contribute to development and progression of diabetic retinopathy and other ocular diseases. In early clinical trials in patients with diabetic retinal disease, nesvategrast eye drops have demonstrated preliminary evidence of tolerability and biological activity.
About OcuTerra Therapeutics
OcuTerra Therapeutics, Inc. is developing innovative drugs for ophthalmic diseases for which the current standard of care does not prevent or control the [early] progression of disease. Our initial therapeutic candidate, nesvategrast (OTT166), administered as an eye drop containing a novel, potent and selective integrin-inhibitor, is in clinical development as an early, non-invasive intervention for diabetic retinopathy, a chronic, progressive disease that is one of the leading causes of vision loss globally. Our goal is to bring transformative treatments to patients and their clinicians who are currently consigned to watch and wait as disease progresses, ultimately requiring medically intensive and invasive therapy. www.ocuterratx.com