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Allegro Ophthalmics Completes Enrollment in DEL MAR Phase 2b, Stage 2 Clinical Trial of Luminate® for the Treatment of Diabetic Macular Edema

December 15, 2016

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SAN JUAN CAPISTRANO — December 15, 2016 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of novel therapies to treat vitreoretinal diseases, today announced completion of enrollment in the second stage of its DEL MAR trial that is evaluating the safety and efficacy of Luminate® in combination and as an adjunctive therapy with anti-VEGFs in patients with diabetic macular edema (DME).  Topline results from the DEL MAR Stage 1 monotherapy trial, in which Luminate met its primary and secondary endpoints, demonstrating equivalence to bevacizumab monotherapy with half the number of injections, were released in October.

DEL MAR Stage 2 is a double masked, placebo-controlled, randomized, multi-center, 5-month Phase 2b trial designed to evaluate the safety and efficacy of intravitreal injections of Luminate 0.5 mg or 1.0 mg in combination with bevacizumab 1.25 mg and as an adjunctive therapy after treatment with a single treatment with bevacizumab 1.25 mg in patients with DME.  The trial enrolled 75 patients and is being conducted at approximately 14 sites across the U.S.  The company expects to report top-line data in the first half of 2017.

“With the recent readout of the topline results of DEL MAR Stage 1 and now the completion of the last patient enrollment in DEL MAR Stage 2, Allegro has achieved another clinical development milestone for this drug candidate,” says Vicken Karageozian, MD, President and Chief Medical Officer, Allegro Ophthalmics. “DEL MAR Stage 1 met its primary and secondary endpoints demonstrating strong efficacy and safety in monotherapy treatment with Luminate.  We are cautiously optimistic that DEL MAR Stage 2 data will show similar outcomes.”

“DEL MAR Stage 1 results appear to be very promising,” said Peter K. Kaiser, M.D., Chaney Family Endowed Chair in Ophthalmology Research and Professor of Ophthalmology, Cleveland Clinic Lerner College of Medicine, and member of Allegro’s Scientific Advisory Board.  “I am hopeful that Luminate in combination or as an adjunctive therapy with anti-VEGFs may prove to be as efficacious as monotherapy treatment with Luminate.  A new option with a completely novel mechanism of action that improves visual and anatomic outcomes would be a welcome addition to doctors and our patients.”

About Luminate
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 2 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 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, 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 www.allegroeye.com.

Luminate® is a registered trademark of Allegro Ophthalmics, LLC.

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