SAN JUAN CAPISTRANO — January 5, 2016 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of therapies to treat vitreoretinal diseases, today announced completion of enrollment in its DEL MAR Phase 2b trial that is evaluating the safety and efficacy of Luminate® (ALG-1001) in patients with diabetic macular edema (DME).
DEL MAR is a double masked, placebo-controlled, randomized, multi-center, 6-month Phase 2b trial designed to evaluate the safety and efficacy of intravitreal injections of Luminate® compared to the current standard of care for patients with DME. The trial enrolled 120 patients who were randomized to one of four treatment groups that included three Luminate® groups (1.0 mg, 2.0 mg, or 3.0 mg) and a bevacizumab group. The trial is being conducted in approximately 40 sites across the U.S.
“Completing the last patient enrollment in the DEL MAR trial on schedule represents another significant clinical development milestone for this drug candidate, and moves us a step closer to potentially bringing this new category of treatment forward to help DME patients,” says Vicken Karageozian, MD, Chief Technical Officer, Allegro Ophthalmics, LLC. “The protocol follows the prospective analysis of the Phase 1 DME study, which demonstrated strong safety and efficacy in monotherapy treatment with Luminate®. We are cautiously optimistic that Phase 2b data will show similar outcomes.”
“I’m pleased to be participating in this important study which has the potential to benefit the millions of diabetics who are at risk of losing their vision,” says David Boyer, MD, Clinical Professor of Ophthalmology at USC/Keck School of Medicine and member of Allegro’s Scientific Advisory Board. “There is a significant need to find better treatment options that reduce the number of intravitreal injections, while improving vision for our diabetic patients. In clinical studies to date, Luminate® has been shown to be an enhanced clinical benefit for those patients who either don’t respond to anti-VEGF therapy or plateau with less than excellent vision.”
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 (vitreolysis and anti-angiogenesis), 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 2b clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), 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 2b 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, wet age-related macular degeneration, and vitreomacular traction. 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 allegroeye.com.
Luminate® is a registered trademark of Allegro Ophthalmics, LLC.
Third party trademarks used herein are trademarks of their respective owners.
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