Trials & Filings

Allegro Begins Vitreomacular Traction Trial

Tests Integrin Peptide Therapy in VMT

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Allegro Ophthalmics has begun a Phase II study of ALG-1001 in patients with vitreomacular traction (VMT). ALG-1001 is a first-in-class Integrin Peptide Therapy targeting integrins, which play a key role in cell signaling and regulating cellular shape, motility, and the cell cycle.

The study is a placebo-controlled, randomized, double-masked, dose-ranging trial to evaluate the safety and efficacy of intravitreal injections of ALG-1001 in patients with VMT. Patients are currently being enrolled at multiple sites outside the U.S., with the primary efficacy endpoint of release of VMT being determined by optical coherence tomography (OCT) images read by Duke Reading Center. Secondary endpoints include the observation of non-surgical closure of full thickness macular holes, BCVA improvement over baseline, and forgone need for pars plana vitrectomy.

ALG-1001 approaches multiple indications by collectively turning off the production, reducing the leakage, and inhibiting the growth of aberrant blood vessels. In addition to its anti-angiogenic effects, ALG-1001 targets the key integrin receptor site at the vitreoretinal interface to release the cellular adhesion between the vitreous and the retina. Accordingly, inducing this separation has the potential to resolve VMT.

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