SAN JUAN CAPISTRANO, CA — October 3, 2016 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of therapies to treat vitreoretinal diseases, today announced completion of enrollment in its PACIFIC Phase 2b clinical trial that is evaluating the safety and efficacy of Luminate® (ALG-1001) in inducing posterior vitreous detachment (PVD) in patients with non-proliferative diabetic retinopathy (DR).
“We are very pleased to have completed patient enrollment in the PACIFIC trial,” said Vicken Karageozian, M.D., President and Chief Medical Officer, Allegro Ophthalmics. “There are currently no practical treatment options available for PVD induction in non-proliferative DR, resulting in 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.”
PACIFIC is the third Phase 2 study of Luminate® to complete enrollment. Top-line results from PACIFIC are anticipated to be available within the first half of 2017, and those from the DEL MAR Phase 2b trials evaluating Luminate® in patients with diabetic macular edema (DME) are expected Q4 2016.
“PACIFIC is an important study that will 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,” said 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, investigator, and member of Allegro’s Scientific Advisory Board. “There is a significant body of evidence that suggests inducing a PVD may inhibit the progression of retinal disease.1-4 An early Phase 1 trial has already demonstrated that Luminate® can induce PVD in patients with DME.”
PACIFIC is a double-masked, placebo-controlled, randomized, multi-center, dose-ranging trial to evaluate intravitreal injections of Luminate® in patients with non-proliferative DR. The trial enrolled 100 patients who were randomized to one of five treatment groups that included four Luminate® groups (1.0 mg, 2.0 mg, 3.0 mg or 4.0 mg) and a balanced salt solution (BSS) placebo group. All study subjects return for examinations every four weeks for five months with the main endpoint being PVD induction based on optical coherence tomography and/or B-scan ultrasound.
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.
Ono R, Kakehashi A, Yamagami H, et al. Prospective assessment of proliferative diabetic retinopathy with observations of posterior vitreous detachment. Int Ophthalmol. 2005;26(1-2):15-19.
Ghazi NG, Ciralsky JB, Shah SM, et al. Optical coherence tomography findings in persistent diabetic macular edema: the vitreomacular interface. Am J Ophthalmol 2007;144(5):747-54.
Ophir A, Trevino A, Fatum S. Extrafoveal vitreous traction associated with diabetic diffuse macular oedema. Eye (Lond) 2010;24(2):347-53.
Tolentino MS, Tolentino AJ, Tolentino MJ. Current and investigational drugs for the treatment of diabetic retinopathy. Expert Opin Investig Drugs 2016;25(9);1011-22.
Luminate® is a registered trademark of Allegro Ophthalmics, LLC.
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