OcuTerra Therapeutics Announces First Patient Dosed in OTT166 Phase 2 DR:EAM Clinical Trial for Diabetic Retinopathy

OTT166 is a potential first-in-class non-invasive selective RGD integrin inhibitor, delivered as eye drop, for the treatment of diabetic retinopathy

OTT166 has the potential to address an unmet need for an earlier, non-invasive ophthalmic treatment for diabetic retinopathy

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 first patient was dosed in its Phase 2 DR:EAM (Diabetic Retinopathy: Early Active Management) clinical trial evaluating OTT166 in adult patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy with minimal vision loss. OTT166 is a novel small molecule selective integrin inhibitor that is designed with purpose engineering to have the required physiochemical characteristics to be able to reach the retina from eye drop application.

“The initiation of the DR:EAM clinical trial marks an important milestone in our efforts to develop potentially the first, topical eye drop treatment for diabetic retinopathy,” said Kerrie Brady, Chief Executive Officer and President of OcuTerra Therapeutics. “OTT166 has demonstrated tolerability and promising evidence of biological activity in patients in a Phase 1b clinical trial and we believe that it has the potential to dramatically change the treatment paradigm by enabling earlier, non-invasive, active treatment for patients with diabetic retinopathy if approved.”

OTT166 has been specifically designed to be administered as an eye drop by the patient at home before diabetic retinopathy has advanced to a vision-threatening complication, such as diabetic macular edema. By potentially enabling earlier non-invasive treatment, OcuTerra’s goal is to prevent progression, thereby delaying or completely eliminating the need for intravitreal injections and/or destructive laser procedures.

“I have been dedicated to providing treatment options for patients with retinal diseases and am honored to be the Principal Investigator for the DR:EAM clinical trial to evaluate the potential of topical OTT166 in our patients with diabetic retinopathy,” said Carl Regillo, M.D., Director, Retina Service, Wills Eye Hospital, Professor of Ophthalmology, Thomas Jefferson University, Philadelphia, PA. “OTT166 is an investigational integrin inhibitor that is designed to reach the retina via topical administration and represents a potential advancement in how diabetic retinopathy is treated. With its proposed mechanism of action and non-invasive delivery, OTT166 may provide an exciting option for diabetic retinopathy patients and possibly help prevent or slow disease progression. It is gratifying to see the first patient dosed in the DR:EAM study.”

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 approximately 200 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 over 8 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 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 Market Scope, Retinal Pharmaceuticals Market Report, 2021

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

Contacts

MacDougall Advisors

Nicholas Chang

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(781) 235-3060