OcuTerra Therapeutics Announces First Patient Dosed in OTT166 Phase 2 DR:EAM Clinical Trial for Diabetic Retinopathy
OcuTerra Therapeutics announced that 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 nonproliferative 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,” Kerrie Brady, Chief Executive Officer and President of OcuTerra Therapeutics, said in a company news release. “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, noninvasive, 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 noninvasive 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,” Carl Regillo, MD, Director, Retina Service, Wills Eye Hospital, Professor of Ophthalmology, Thomas Jefferson University, Philadelphia, said in a company news release. “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.