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Luminate meets primary endpoint in phase 2 study
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The phase 2 study evaluating the safety and efficacy of Luminate in patients with vitreomacular traction or vitreomacular adhesion has met its primary endpoint, Allegro Ophthalmics announced in a press release.
The prospective, double-masked, placebo-controlled study included 106 patients randomized to receive 2 mg, 2.5 mg or 3.2 mg Luminate (ALG-1001) or a balanced salt solution placebo.
The primary endpoint of vitreomacular traction or vitreomacular adhesion release was achieved by day 90 in 65% of eyes treated with the 3.2 mg dose of Luminate compared with 9.7% of eyes in the placebo group. Luminate was well-tolerated and no drug toxicity or intraocular inflammation occurred with repeated intravitreal injections, according to the release.
“The vitreolytic properties confirmed in this study and the antiangiogenic properties demonstrated in earlier diabetic macular edema and neovascular age-related macular edema studies continue to validate our clinical development approach of advancing Luminate across multiple vitreoretinal indications,” Vicken Karageozian, MD, chief technical officer of Allegro, said in the release.
Luminate has not been approved by the FDA for commercial sale in the U.S.