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Allegro Ophthalmics LLC has announced the start of a phase II study of ALG-1001 in patients with vitreomacular traction (VMT).
San Juan Capistrano, CA-Allegro Ophthalmics LLC has announced the start of a phase II study of ALG-1001 in patients with vitreomacular traction (VMT).
The study is a placebo-controlled, randomly assigned, double-masked, dose-ranging trial to evaluate the safety and efficacy of intravitreal injections of the drug in patients with VMT.
Patients are currently being enrolled at multiple sites outside the United States, with the primary efficacy endpoint of release of VMT being determined by optical coherence tomography images read by Duke Reading Center.
Secondary endpoints include the observation of non-surgical closure of full thickness macular holes and forgone need for pars plana vitrectomy.
“Current options for treating VMT are limited for the majority of patients,” said David Boyer, MD, clinical professor of ophthalmology at the University of Southern California’s Keck School of Medicine and member of Allegro’s scientific advisory board. “While this is the first human study using (the drug) to treat VMT, the success of it in achieving total resolution of posterior vitreous detachment in earlier studies gives us great optimism for the current study in VMT.”
“We are excited about the initiation of this phase II clinical study with (the drug) for a third indication,” said Vicken Karageozian, MD, co-founder and chief technical officer, Allegro Ophthalmics. “Following study results from other indications-along with allowance from the FDA to proceed with phase II studies-we are confident that this study will continue to affirm the safety and efficacy of (the drug), and are hopeful that it will provide meaningful therapeutic benefits to patients with VMT.”
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