Allegro’s Luminate Posts Positive Results in Phase IIb Stage 2 Trial for Diabetic Macular Edema

August 11, 2017: By Jon Swedien

Allegro logoAllegro Ophthalmics on Aug. 9 reported positive results from its Phase IIb Stage 2 clinical trial for Luminate.

Luminate—a first-in-class integrin peptide therapy that treats neovascular retinal diseases—met its primary endpoint when used as a sequential therapy in patients with diabetic macular edema (DME) in the DEL MAR Stage 2 study, according to the San Juan Capistrano, California, company.

The primary endpoint was non-inferiority to bevacizumab in mean change in best-corrected visual acuity (BCVA) at 20 weeks when Luminate was used with a single bevacizumab pretreatment (sequential therapy) or in combination with bevacizumab.

The Luminate results were achieved after one treatment of 1.25 mg bevacizumab (week zero) followed by three 1 mg Luminate injections (weeks one, four, and eight) and 12 weeks off treatment, compared with five injections given every four weeks with bevacizumab.

The data showed the mean gain in BCVA was 7.1 letters for patients in the Luminate with bevacizumab pretreatment (sequential) group compared with 6.7 letters for patients in the bevacizumab control group.

The double-masked, placebo-controlled, randomized, multicenter, five-month Phase IIb, Stage 2 trial, conducted at 14 US sites, included five arms:

— Luminate 0.5 mg or 1.0 mg as a sequential therapy after a single treatment of 1.25 mg bevacizumab (week zero) followed by three Luminate injections (weeks one, four, and eight), and 12 weeks off treatment;

— Luminate 0.5 mg or 1.0 mg given in direct combination with bevacizumab 1.25 mg at weeks one, four, and eight, and 12 weeks off treatment;

— A 1.25 mg bevacizumab control arm of five monthly injections.

The trial also found that Luminate was well-tolerated with no drug toxicity or intraocular inflammation. These safety results are consistent with previously conducted Luminate studies on human subjects where there were no reports of significant inflammation and no evidence of retinal tears or detachments.

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