Allegro Ophthalmics 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,” Vicken Karageozian, MD, President and Chief Medical Officer, Allegro Ophthalmics, said in a company news release. “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. Topline 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,” Baruch Kuppermann, MD, PhD, 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, said in the news release. “There is a significant body of evidence that suggests inducing a PVD may inhibit the progression of retinal disease. 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, multicenter, 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.