Allegro Ophthalmics, LLC announced yesterday positive topline results of its U.S. Phase 2 study of risuteganib (Luminate®) for the treatment of intermediate nonexudative age-related macular degeneration (dry AMD). The clinical trial met its primary endpoint with 48 percent of patients in the risuteganib arm gaining ≥ 8 letters of vision at week 28 compared to baseline.
The primary endpoint of the Phase 2 study was the proportion of subjects with a ≥ 8 letters of vision gain with two risuteganib injections versus one sham treatment. The 40-patient trial was a prospective, randomized, double-masked, placebo-controlled, multi-center U.S. study that evaluated the safety and efficacy of risuteganib in patients with intermediate dry AMD.
The primary endpoint was met with 48 percent of patients in the risuteganib arm at week 28 and 7 percent of patients in the sham group at week 12 gaining ≥ 8 letters from baseline (p=0.013). Risuteganib was found to be safe with no reported drug related serious adverse events (SAEs). Secondary outcomes, including microperimetry, color vision, and low luminance visual acuity, are currently being evaluated; results of which will be released in the upcoming weeks.
“Allegro’s anti-integrin portfolio continues to show great progress,” said Vicken Karageozian, M.D., President and CEO of Allegro Ophthalmics, LLC. “This progress is supported by recent findings released last month establishing that our ALG-1007 drug candidate for dry eye disease performed well in an ex-U.S. proof-of-concept clinical trial and now by these positive topline U.S. Phase 2 results of risuteganib for intermediate dry AMD. It is very encouraging to see such robust visual acuity gains in patients with dry AMD, a sight-threatening disease for which there is currently no available treatment. It is also exciting to see that these initial clinical findings in dry AMD confirm our extensive preclinical findings and earlier clinical studies that suggested risuteganib could restore visual function.”
The full study results, including primary and secondary outcomes, will be presented by Dr. Kaiser at the American Society of Retina Specialists (ASRS) Annual Meeting 2019 in Chicago, IL on Saturday, July 27th.
News source: https://www.allegroeye.com/allegro-ophthalmics-expands-its-anti-integrin-portfolio-with-new-front-of-the-eye-drug-candidate-alg-1007-for-the-treatment-of-dry-eye-disease-3-2-2/
Source: Allegro Ophthalmics