DENVER, CO — MAY 4, 2015 — Allegro Ophthalmics, LLC, today announced that it has begun enrolling patients in a Phase 2 clinical trial that will evaluate the safety and efficacy of Allegro’s first-in-class integrin peptide therapy candidate Luminate® (ALG-1001) in inducing posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (DR).
“We have already seen good evidence that Luminate can induce PVD in patients with diabetic macular edema,” says Baruch Kuppermann, M.D., Ph.D., Professor of Ophthalmology and Biomedical Engineering, Chief of the Retina Service, and Vice-Chair of Academic Affairs at the Gavin Herbert Eye Institute, University of California Irvine School of Medicine, and member of Allegro’s Scientific Advisory Board. “I am pleased to participate in this important study to broaden and confirm our understanding of this non-surgical option for patients with mild to moderate non-proliferative diabetic retinopathy who may potentially proceed to vision threatening disease over time. In early phase clinical studies to date, Luminate has been shown to be effective as monotherapy treatment and to meaningfully reduce the burden of intravitreal injections in DME and wet AMD.”
“The initiation of this Phase 2 trial is an important step in advancing our clinical development plan,” says Vicken Karageozian, M.D., Chief Technical Officer, Allegro Ophthalmics. “Given the lack of practical treatment options currently available for PVD induction in non-proliferative DR, there is a significant need for novel, non-surgical treatments that optimize long-term clinical outcomes. We are optimistic that Luminate will continue to show efficacy and provide meaningful therapeutic benefit to patients with diabetic retinopathy and other vitreoretinal diseases.”
This Phase 2 study is a randomized, double-masked, placebo-controlled, multi-center dose-ranging trial to evaluate the safety and efficacy of intravitreal injections of Luminate in patients with non-proliferative DR. Patients will be randomized to one of four treatment groups that include three Luminate groups (1.0 mg, 2.0 mg, or 3.0 mg) and a placebo group. All study subjects will return for examinations every four weeks for three months. Total planned enrollment for the trial is 100 subjects.
Luminate, a first-in-class integrin peptide therapy, treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels. By utilizing two mechanisms of action (anti-angiogenesis and vitreolysis), Luminate has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision. Currently in Phase 2 clinical trials for multiple indications, including diabetic macular edema (DME) and vitreomacular traction (VMT), Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S. Allegro maintains commercial rights to Luminate in all territories outside of Japan, Korea and China.
About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is working to establish integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases. Allegro’s lead investigational drug, Luminate, is currently in Phase 2 studies and has the potential to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema, diabetic retinopathy, and wet age-related macular degeneration. By quickly, safely and cost-effectively bringing to market new and improved treatment options for leading causes of blindness, Allegro is committed to offering patients an improved quality of life sustained by self-sufficient, functional vision. For more information, visit stg.allegroeye.com.
Luminate® is a registered trademark of Allegro Ophthalmics, LLC.
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