CHICAGO, IL — October 16, 2014 — Allegro Ophthalmics, LLC, dedicated to establishing integrin peptide therapy as the next-generation pharmaceutical category for the treatment of vitreoretinal diseases, today announced that it is enrolling patients in a Phase 2 trial that will evaluate the safety and efficacy of Luminate®, previously known as ALG-1001, in patients with diabetic macular edema (DME).
This Phase 2 study is a randomized, controlled, double-masked, multi-center, dose-ranging trial to evaluate the safety and efficacy of intravitreal injections of Luminate® compared to the current standard of care for patients with DME. Patients will be randomized to one of five treatment groups that include three Luminate® groups (1.0 mg, 2.0 mg, or 3.0 mg), a bevacizumab (Genentech) group, and a focal laser photocoagulation group. All study subjects will return for examinations every four weeks for six months. Total planned enrollment for the trial is 150 patients.
“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, M.D., 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 helping a larger patient population. In clinical studies to date, Luminate® has been shown to be effective as monotherapy treatment to meaningfully reduce the burden of intravitreal injections, while also providing a clinical benefit for those patients who either don’t respond to anti-VEGF therapy or plateau with less than excellent vision.
“This Phase 2 clinical study design follows the prospective analysis of the Phase 1 DME study, which demonstrated strong safety and efficacy in monotherapy treatment with Luminate®,” says Vicken Karageozian, M.D., Chief Technical Officer, Allegro Ophthalmics, LLC. “In the Phase 1 study, eight of 15 end-stage DME patients treated with Luminate® experienced a three to five line improvement in visual acuity with a corresponding improvement in macular anatomy as measured three months off treatment.”
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 to be effective at regressing and inhibiting new blood vessel formation, as well as reducing vascular leakage to maintain and restore vision. Luminate® is an investigational drug not approved by the FDA.
About Allegro Ophthalmics, LLC
With more than 100 years of combined experience in ophthalmic drug discovery, development and manufacturing, Allegro Ophthalmics, LLC, is establishing 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 been shown to significantly reduce the current burden of intravitreal injections and to be a viable option for patients with diabetic macular edema 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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