FDA approves avacincaptad pegol for geographic atrophy secondary to AMD
The U.S. Food and Drug Administration has approved IZERVAY (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), according to a press release.
The FDA approved IZERVAY based on the positive outcomes of the GATHER1 and GATHER2 trials, where it demonstrated efficacy in slowing the progression of GA in patients with AMD over a 12-month period. This is the only approved GA treatment with a statistically significant reduction (P < 0.01) in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials.
“We are thrilled to receive FDA approval of IZERVAY and to offer a new therapy to physicians and appropriate patients in the U.S. Time matters, vision matters, and safety matters in this devastating progressive disease. We would like to thank everyone involved in reaching this milestone and helping us deliver on our commitment to pioneer transformational therapies for retinal diseases,” said Pravin U. Dugel, MD, President, Iveric Bio, An Astellas Company in the press release.
Read the full press release here.