SAN JUAN CAPISTRANO, Calif.--(BUSINESS WIRE)--Allegro Ophthalmics, LLC, today announced that the Phase 2 clinical trial of Luminate® (ALG-1001) in patients with vitreomacular traction (VMT) or vitreomacular adhesion (VMA) met its primary endpoint. In the phase 2, prospective, randomized, double-masked, placebo-controlled trial evaluating the safety and efficacy of intravitreal injections of Luminate in 106 study subjects, 65 percent of eyes treated with the 3.2 mg dose of Luminate achieved release of VMT or VMA by Day 90 (end of study), compared to 9.7 percent of those in the placebo control group (p=0.0129).
The study, which included three Luminate groups (2.0 mg, 2.5 mg, or 3.2 mg) and a balanced salt solution (BSS) placebo group, also found that Luminate was well-tolerated with no drug toxicity or intraocular inflammation noted with repeated intravitreal injections. These safety results are consistent with previously conducted Luminate studies on human subjects where there were no rod or cone photoreceptor dysfunction on full-field electroretinogram testing, no afferent pupillary defects, and no evidence of retinal tears or detachments.
Luminate, a first-in-class integrin peptide therapy, 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 two mechanisms of action (vitreolysis and anti-angiogenesis), Luminate has been shown in clinical studies to date to effectively regress and inhibit new blood vessel formation, as well as reduce vascular leakage to maintain and restore vision. Currently in Phase 2 clinical trials for multiple indications, including diabetic macular edema (DME) and non-proliferative diabetic retinopathy (NPDR), Luminate is an investigational drug not approved by the FDA for commercial sale in the U.S. Allegro maintains commercial rights to Luminate in all territories outside of Japan, Korea and China.
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