Dive Brief:
- Allegro Ophthalmics said Thursday its integrin peptide therapy, Luminate (ALG-1001), improved vision acuity in a Phase 2b trial of patients with diabetic macular edema.
- According to top-line results, Luminate hit both its primary and secondary endpoints in the study, the San Juan Capistrano, CA-based company said.
- Luminate is part of a new class of treatments various eye diseases, including diabetic macular edema, a leading cause of irreversible blindness which affects 750,000 people, according to the National Institutes of Health.
Dive Insight:
Luminate demonstrated promising visual acuity gains for people with diabetic macular edema, and a reduction in central macular thickness equivalent to Avastin (bevacizumab), a standard treatment used to slow vision loss, Allegro said.
Diabetic macular edema (DME) is caused by a complication of diabetes called diabetic retinopathy. Diabetic retinopathy is the most common diabetic eye disease and the leading cause of irreversible blindness in working-age Americans.
The primary endpoint in the Phase 2b trial was non-inferiority to bevacizumab in best-corrected visual acuity (BCVA) at 20 weeks. The company said the Luminate results were achieved after 3 injections and 12 weeks of treatment, compared to 6 injections given every 4 weeks with bevacizumab. The study also found that Luminate was well tolerated with no drug toxicity or intraocular inflammation.
“With half the number of injections and a unique mechanism of action, Luminate has demonstrated non-inferiority to anti-VEGF injections and appears to be extremely well-tolerated,” said Peter K. Kaiser, a professor of ophthalmology at Cleveland Clinic Lerner College of Medicine and a member of Allegro’s scientific advisory board.
“Luminate may potentially provide physicians and DME patients with a completely new option that improves visual and anatomic outcomes while reducing the burden of intravitreal injections,” he said.
Luminate is in clinical trials for a number of other indications, including non-proliferative diabetic retinopathy, which has not yet been approved by the FDA.