Allegro Ophthalmics, LLC, a company dedicated to establishing Integrin Peptide Therapy as the next-generation pharmaceutical category for the treatment of vascular eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application to begin two Phase II clinical studies of ALG-1001. These Phase II clinical trials will be conducted in patients with wet age-related macular degeneration (wet AMD) and in patients with symptomatic vitreomacular traction (VMT).
"We are extremely pleased with the FDA's approval, which validates our preclinical data, multiple Phase I study results, and Phase II clinical study design," said Vicken Karageozian, M.D., Co-Founder and Chief Technical Officer, Allegro Ophthalmics. "In just over three years, we've rapidly and methodically gone from compound discovery to Phase II clinical trials. We are optimistic that this drug will continue to show efficacy and provide meaningful therapeutic benefit to patients with vascular eye diseases such as wet AMD and VMT."
These Phase II studies will be the fifth and sixth studies of ALG-1001. Completed already are two Phase I studies - one monotherapy study in each of diabetic macular edema (DME) and wet AMD. Additionally, two Phase Ib/IIa studies are in progress, with one being a combination study in DME. To date, all data from human studies, as well as studies in animals, show Integrin Peptide Therapy to be safe, well-tolerated and efficacious, including the fact that the benefit of monotherapy is holding at least three months off-treatment in both wet AMD and DME patients.