Trial for diabetic retinopathy treatment gets underway

Allegro Ophthalmics announced that it has begun enrolling patients in a Phase 2 clinical trial to evaluate the safety and efficacy of its integrin peptide therapy candidate, Luminate (ALG-1001), for inducing posterior vitreous detachment (PVD) in patients with nonproliferative diabetic retinopathy.

The Phase 2 study is a randomized, double-masked, placebo-controlled, multi-center trial in which 100 nonproliferative diabetic retinopathy patients will be randomized to receive intravitreal injections of Luminate 1.0 mg, 2.0 mg or 3.0 mg or placebo. They will be followed for 3 months.

Luminate is currently in Phase 2 clinical trials for diabetic macular edema and vitreomacular traction.

It is a first-in-class integrin peptide therapy that treats vitreoretinal diseases by targeting integrin receptors involved in cell signaling and regulation and in the construction of new and aberrant blood vessels. By utilizing 2 mechanisms of action (anti-angiogenesis and vitreolysis), Luminate has been shown in clinical studies to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision.

“We have already seen good evidence that Luminate can induce PVD in patients with diabetic macular edema,” says Baruch Kuppermann, MD, PhD, professor of ophthalmology and biomedical engineering and chief of the Retina Service at the Gavin Herbert Eye Institute at the University of California Irvine School of Medicine, and member of Allegro’s Scientific Advisory Board. “In early phase clinical studies to date, Luminate has been shown to be effective as monotherapy treatment and to meaningfully reduce the burden of intravitreal injections in DME and wet AMD.”