DEL MAR Study Meets Primary and Secondary Endpoints Demonstrating
Equivalence to Anti-VEGF with Half the Number of Injections
SAN JUAN CAPISTRANO, CA — October 13, 2016 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of novel therapies to treat vitreoretinal diseases, today announced that the DEL MAR Phase 2b clinical trial evaluating Luminate® (ALG-1001) in 136 patients with diabetic macular edema (DME) met its primary and secondary endpoints, demonstrating promising visual acuity gains and reduction in central macular thickness (CMT) that were equivalent to bevacizumab monotherapy.
The primary endpoint of the DEL MAR Phase 2 study was non-inferiority to bevacizumab (defined as ≤3-letter difference) in mean change in best-corrected visual acuity (BCVA) at 20 weeks. The Luminate® results were achieved after 3 injections and 12 weeks off treatment, compared to 6 injections given every 4 weeks with bevacizumab. The data showed the mean gain in BCVA was 5.2 letters for patients in the 1.0 mg Luminate® arm 12 weeks off Luminate® loading compared to 7.0 letters for patients in the 1.25 mg bevacizumab arm dosed every 4 weeks. The secondary endpoint was non-inferiority to bevacizumab (defined as ≤30 µm difference) in mean change in CMT as measured by optical coherence tomography (OCT). At week 20, patients in the 1.0 mg Luminate® arm showed a mean reduction of 77µm 12 weeks off Luminate® loading versus 104µm in the 1.25 mg bevacizumab arm dosed every 4 weeks.
The controlled, double-masked, multi-center, dose-ranging study, which included three Luminate® arms (1.0 mg, 2.0 mg, and 3.0 mg) treated with 3 monthly Luminate® loading injections followed by 12 weeks off treatment, and a 1.25 mg bevacizumab arm of 6 monthly injections, also found that Luminate® was well-tolerated with no drug toxicity or intraocular inflammation noted. These safety results are consistent with previously conducted Luminate® studies on human subjects where there were no reports of significant inflammation, no afferent pupillary defects, and no evidence of retinal tears or detachments.
“These positive results continue to affirm the safety and efficacy of Luminate®, and confirm its 12-week monotherapy durability,” said Vicken Karageozian, M.D., President and Chief Medical Officer, Allegro Ophthalmics. “Allegro is deeply committed to developing novel therapies that address vitreoretinal patients’ unmet needs with new mechanisms of action that have the potential to help a larger population.”
“The DEL MAR Phase 2 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. “With half the number of injections and a unique mechanism of action, Luminate® has demonstrated non-inferiority to anti-VEGF injections and appears to be extremely well-tolerated. Luminate® may potentially provide physicians and DME patients with a completely new option that improves visual and anatomic outcomes while reducing the burden of intravitreal injections.”
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 allegroeye.com.
Luminate® is a registered trademark of Allegro Ophthalmics, LLC.
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