OcuTerra Announces Publication of Safety and Biological Activity Data of OTT166 from Phase 1b Study in Diabetic Eye Disease

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BOSTON–(BUSINESS WIRE)–OcuTerra Therapeutics, Inc. (“OcuTerra”), a clinical-stage ophthalmology company developing innovative medicines to treat ophthalmic diseases for which the current standard of care of “watch and wait” does not prevent or control the disease progression, today announced the publication of a paper entitled “The Safety and Biological Activity of OTT166, a Novel Topical Selective Integrin Inhibitor for the Treatment of Diabetic Eye Disease: A Phase 1b Study” in Ophthalmic Surgery, Lasers and Retina Imaging (OSLI Retina). The data show that OTT166 eye drops were well tolerated and demonstrated biological activity, warranting further evaluation for the treatment of diabetic eye disease.

In this Phase 1b study, the first in humans, 44 patients with diabetic retinopathy (DR) who presented with the sight-threatening complication of diabetic macular edema (DME) received a concentration of 2.5% or 5 % OTT166 as eye drops twice daily for 28 days. . Subjects were then followed for an additional 28 days without further treatment (observation phase), with 40 subjects completing the trial. As a phase 1 study, no formal statistical hypotheses have been tested. OTT166 was well tolerated with no evidence of ocular or systemic toxicity, no serious drug-related adverse events were reported, and generally stable BCVA throughout the study. There was a clinically significant reduction in mean and median central retinal thickness (CRT) in both groups combined at the end of the study (-22/-28 microns, respectively) and 37% was considered clinical responders as judged by three specialist retinas reviewing each patient’s OCT scans.). Based on these results, the Phase 2 DR:EAM study is underway to evaluate the safety and efficacy of OTT166 in diabetic retinopathy.

“Data reported from OcuTerra’s Phase 1 DR/DME study clearly showed that OTT166 eye drops were well tolerated and demonstrated a robust biological activity signal worthy of continued evaluation,” said Jeffrey Heier, MD, Director of Vitreoretinal Service and Director of Retina Research. at Ophthalmic Consultants of Boston (OCB), one of the largest multi-specialty ophthalmology practices in the United States, and lead author and study investigator. “I am encouraged that we are developing a non-invasive treatment alternative which, if approved, I could potentially start my patients earlier in their disease course and possibly delay or even prevent disease progression. retinopathy to the point that repeated injections and/or laser would be indicated. As a member of OcuTerra’s Scientific Advisory Board and investigator of the DR:EAM Phase 2 study, I look forward to participating in the next phases of development.

“Current treatments available to people with severe diabetic eye disease leave significant unmet medical needs, with most patients having to wait until their disease progresses to the advanced stage, at which time their only options are often invasive and binding,” said David Tanzer, MD, chief medical officer of OcuTerra Therapeutics. “The opportunity to provide non-invasive therapy to treat DR earlier has the potential to transform the standard of care. We are pleased to share these positive results from the completed study, and look forward to continued work in the ongoing DR:EAM Phase 2 (Ddiabetic Retinopathy: Eearly Aasset Mmanagement ) study by OTT166.

About OTT166

OTT166 is an investigational, novel, patented, potent and selective small molecule RGD integrin inhibitor designed with specific engineering to have an optimal balance of physiochemical properties to enable it to deliver to the retina at high concentrations after topical administration (eye drops) to the eye. In preclinical studies, OTT166 selectively inhibited major RGD integrin subtypes, including αvβ3, to regulate cellular responses to VEGF and other growth factors known to contribute to the development and progression of retinopathy diabetic and other eye diseases. In early clinical trials in patients with diabetic retinal disease, OTT166 eye drops demonstrated preliminary evidence of tolerability and biological activity.

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, affecting more than 8 million people in the United States.1. The current standard of care for diabetic retinopathy is active surveillance or “watch and wait”2 until a sight-threatening complication occurs. When vision deteriorates further due to complications, the patient usually must have injections of drugs directly into the back of the eye (intravitreal injection) or undergo destructive laser procedures to help stop the growth of new blood vessels and reduce fluid buildup.

About the Phase 1b Clinical Trial

The Phase 1b clinical trial in DR/OMD (NCT02914613) was a prospective, randomized, double-blind, first-in-human study of OTT166 eye drops (formerly designated SF0166) in patients with DR/OMD, it is ie diabetic retinopathy with central diabetic macular edema, conducted at six clinical sites in the United States. The study population included male and female subjects, 18 years of age or older, with diabetic macular edema (i.e. spectral domain optical coherence tomography [OCT]) and no treatment with anti-vascular endothelial growth factor (VEGF) therapy in the study eye within 60 days of study entry. The primary objective was to determine the safety of two different strengths of OTT166 eye drops when self-administered twice daily for 28 days. There was a post-treatment follow-up period of 28 days.

About the DR:EAM clinical trial

DR:EAM is a multicenter, randomized, double-blind clinical trial designed to evaluate the safety and efficacy of high and low dose 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 who show a two-step improvement on the Diabetic Retinopathy Severity Scale (DRSS). Additional clinical trial endpoints include measurement of prevention of progression to vision-threatening complications, time to intravitreal injection and/or laser treatment, and treatment endpoints. exploratory imagery. More information about this trial is available at ClinicalTrials.gov.

About OcuTerra Therapeutic

OcuTerra Therapeutics, Inc. develops innovative medicines for ophthalmic diseases for which the current standard of care does not prevent or control the [early] disease progression. Our initial therapeutic candidate, OTT166, administered as eye drops 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 l one of the leading causes of vision loss in the world. Our goal is to bring transformative treatments to patients and their clinicians who are currently forced to watch and wait for disease progression, ultimately requiring medically intensive and invasive therapy. www.oterratx.com

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1
Market Scope, Retinal Pharmaceuticals Market Report, 2021

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

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