Allegro Ophthalmics 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 study evaluated Luminate as a sequential therapy or in combination therapy with anti-VEGF in 80 patients with DME. The 1.0 mg dose of Luminate in sequential therapy demonstrated visual acuity gains equivalent at all time points to bevacizumab monotherapy and again showed 12-week durability after the completion of three loading doses. Results from the DEL MAR Stage 1 trial, in which Luminate met its primary and secondary endpoints as a monotherapy treatment for DME, were released in October 2016.
The primary endpoint of the DEL MAR Phase 2 Stage 2 study 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 pre-treatment (sequential therapy) or in combination with bevacizumab. The Luminate results were achieved after one treatment of 1.25 mg bevacizumab (week 0) followed by three 1.0 mg Luminate injections (weeks 1, 4, and 8) and 12 weeks off treatment, compared to 5 injections given every 4 weeks with bevacizumab. The data showed the mean gain in BCVA 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,” Vicken Karageozian, MD, President and Chief Medical Officer, Allegro Ophthalmics, said in a news release. “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.”
“These study results are very promising,” David S. Boyer, MD, Clinical Professor of Ophthalmology, USC/Keck School of Medicine; Founder, Retina Vitreous Associates Medical Group; and, member of Allegro’s Scientific Advisory Board, said in the news release. “Not only could Luminate be used as an effective monotherapy with fewer injections, but the latest data suggests that this drug, with its unique mechanism of action, when used as a sequential therapy with an anti-VEGF agent, may provide physicians and DME patients with a new treatment paradigm for DME. Used this way, Luminate with an anti-VEGF pre-treatment could be used to clear VEGF, decrease VEGF production, and cut inflammation at the same time. This should be particularly useful for half of the current patient population that doesn’t respond adequately to repeated anti-VEGF treatments alone.”
The double masked, placebo-controlled, randomized, multi-center, 5-month Phase 2b, Stage 2 trial included 5 arms:
• Luminate 0.5 mg or 1.0 mg as a sequential therapy after a single treatment of 1.25 mg bevacizumab (week 0) followed by three Luminate injections (weeks 1, 4, and 8), and 12 weeks off treatment
• Luminate 0.5 mg or 1.0 mg given in direct combination with bevacizumab 1.25 mg at weeks 1, 4, and 8, and 12 weeks off treatment
• A 1.25 mg bevacizumab control arm of 5 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. The study was conducted at 14 U.S. sites.