San Juan Capistrano, CA-The FDA has approved Allegro Ophthalmics’ investigational new drug application to begin phase II clinical studies of ALG-1001, an integrin peptide therapy.
The clinical trials will be conducted in patients with wet age-related macular degeneration (AMD) and in patients with symptomatic vitreomacular traction (VMT).
“We are extremely pleased the FDA’s approval, which validates our preclinical data, multiple phase I study results, and phase II clinical study design,” said Vicken Karageozian, MD, co-founder and chief technical officer, Allegro Ophthalmics. “We are optimistic that this drug will continue to show efficacy and provide meaningful therapeutic benefits to patients with vascular eye diseases such as wet AMD and VMT.”
The phase II studies will be the fifth and sixth studies of the drug. Already completed are two phase I studies-one monotherapy study in each 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 in animals-show integrin peptide therapy to be safe, well-tolerated and efficacious.
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