This article is more than 5 years old. Information may no longer be current.
Luminate meets primary endpoint in phase 2b trial for DME
Click Here to Manage Email Alerts
Allegro Ophthalmics’ phase 2b stage 2 DEL MAR study of Luminate for diabetic macular edema has met its primary endpoint, according to a company press release.
The double-masked, placebo-controlled, randomized, multicenter clinical trial had five arms and evaluated Luminate, a first-in-class integrin peptide therapy, as a sequential therapy or in combination with anti-VEGF in 80 patients, the release said.
The primary endpoint was noninferiority to Avastin (bevacizumab, Genentech) regarding mean change in best corrected visual acuity at 20 weeks when Luminate was used with a single bevacizumab pretreatment or in combination with bevacizumab. The mean gain in BCVA was 7.1 letters for patients in the group receiving Luminate with bevacizumab pretreatment compared with 6.7 letters for patients in the bevacizumab control group.
“Positive results in DEL MAR stages 1 and 2 continue to confirm Luminate’s safety and efficacy and its 12-week durability in patients with DME,” Vicken Karageozian, MD, Allegro’s president and chief medical officer, said in the release. “What’s more, about 60% of those treated in the DEL MAR trial had been chronic anti-VEGF users, which suggests that Luminate, with its unique mechanism of action, may successfully treat more patients, including those who don’t respond to anti-VEGF.”