SAN JUAN CAPISTRANO — January 5, 2016 — Allegro Ophthalmics, LLC, a biotechnology company focused on the development of therapies to treat vitreoretinal diseases, today announced completion of enrollment in its DEL MAR Phase 2b trial that is evaluating the safety and efficacy of Luminate® (ALG-1001) in patients with diabetic macular edema (DME). The company expects to report top-line data by third quarter 2016.
DEL MAR is a double masked, placebo-controlled, randomized, multi-center, 6-month Phase 2b trial designed to evaluate the safety and efficacy of intravitreal injections of Luminate compared to the current standard of care for patients with DME. The trial enrolled 120 patients who were randomized to one of four treatment groups that included three Luminate groups (1.0 mg, 2.0 mg, or 3.0 mg) and a bevacizumab group. The trial is being conducted in approximately 40 sites across the U.S.
“Completing the last patient enrollment in the DEL MAR trial on schedule represents another significant clinical development milestone for this drug candidate, and moves us a step closer to potentially bringing this new category of treatment forward to help DME patients,” says Vicken Karageozian, MD, Chief Technical Officer, Allegro Ophthalmics, LLC. “The protocol follows the prospective analysis of the Phase 1 DME study, which demonstrated strong safety and efficacy in monotherapy treatment with Luminate. We are cautiously optimistic that Phase 2b data will show similar outcomes.”
- See more at: http://www.allegroeye.com/press-release/allegro-ophthalmics-announces-last-patient-enrolled-in-del-mar-phase-2b-clinical-trial-of-luminate-for-the-treatment-of-diabetic-macular-edema/#sthash.7Af2ry0Q.dpuf
Read more: http://www.allegroeye.com/press-release/allegro-ophthalmics-announces-last-patient-enrolled-in-del-mar-phase-2b-clinical-trial-of-luminate-for-the-treatment-of-diabetic-macular-edema/