In November 2013, Allegro Ophthalmics, LLC announced the commencement of a Phase II study of ALG-1001 in patients with vitreomacular traction (VMT).
The study evaluated the safety and efficacy of intravitreal injections of ALG-1001 in patients with VMT. Patients were enrolled at multiple sites outside the United States, with the primary efficacy endpoint of non-surgical release of the vitreous gel from the retina. These “adhesions” pull on the retina and can cause sight-threatening damage to the tissue. Researchers also hoped to see non-surgical closure of full thickness macular holes, improvement in visual acuity, and no need for further surgery.
In October 2014, Allegro reported that ALG-1001 was shown to inhibit the growth and leakage of aberrant blood vessels. The company announced that it was enrolling patients in a Phase 2 trial to evaluate the safety and efficacy of ALG-1001 (now named Luminate) in patients with diabetic macular edema (DME).
In August 2017, researchers announced that the DEL MAR Phase 2b Stage 2 clinical trial met its primary endpoint when used as a sequential therapy in patients with diabetic macular edema (DME). The data showed the mean gain in best corrected visual acuity was 7.1 letters for patients in the Luminate with bevacizumab pre-treatment (sequential) group compared to 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,” said Vicken Karageozian, M.D., President and Chief Medical Officer, Allegro Ophthalmics. “What’s more, about 60 percent 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.”