OcuTerra Completes Enrollment in Phase 2 DR:EAM Clinical Trial of Topically Delivered OTT166 in Adults with Diabetic Retinopathy

Topline results expected to be released in Q1 2024

OTT166 could enable earlier non-invasive treatment of diabetic retinopathy, a devastating and prevalent condition that can lead to irreversible vision loss

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 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 non-proliferative 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,” said Kerrie Brady, President and CEO of OcuTerra Therapeutics. “With limited therapeutic options for the treatment of DR on the market, we recognize an immense need for a non-invasive, 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.

“Now that we’ve reached full enrollment for the Phase 2 DR:EAM study, the clinical team looks forward to fully evaluating the data on OTT166’s safety, efficacy and activity early next year,” said David Tanzer, M.D., board-certified ophthalmologist and Chief Medical Officer of OcuTerra Therapeutics. “Through purpose engineering of the molecule and a patient-focused approach, we believe that OTT166 could bring a major shift in how and when DR is treated.”

“OTT166 has demonstrated robust biological activity and the potential to modulate multiple key drivers of DR,” added Carl Regillo, M.D., Director, Retina Service, Wills Eye Hospital; Professor of Ophthalmology, Thomas Jefferson University; and Principal Investigator for the DR:EAM clinical trial. “This is an essential milestone for the development of a treatment that could benefit millions of patients with DR.”

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. 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.

About OTT166

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, OTT166 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, OTT166 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, 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

¹ Lundeen EA et. Al. Prevalence of Diabetic Retinopathy in the US in 2021. JAMA Ophthalmology doi:10.1001/jamaophthalmol.2023.2289 Published online June 15, 2023.

² American Academy of Ophthalmology: Preferred Practice Pattern for Diabetic Retinopathy, 2019

Contacts

MacDougall Advisors

Carolyn Noyes

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