August 8, 2023
TOKYO — Astellas Pharma Inc. announced the U.S. Food and Drug Administration (FDA) approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Izervay, a new complement C5 inhibitor, 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.,” said Pravin U. Dugel, MD, president, Iveric Bio, an Astellas Company. “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.”
The FDA approval was based on the GATHER1 and GATHER2 Phase 3 clinical trials, which evaluated the safety and efficacy of monthly 2 mg intravitreal administration of Izervay in patients with GA secondary to AMD. The rate of GA growth was evaluated at baseline, six months, and 12 months. In each registrational trial, over a 12-month period, the primary analysis showed a statistically significant reduction in the rate of GA growth in patients treated with Izervay compared to sham. Slowing of disease progression was observed as early as six months with up to a 35% reduction in the first year of treatment.
“Geographic atrophy has a devastating impact on patients’ lives and can lead to irreversible vision loss,” said Arshad M. Khanani, MD, MA, FASRS, director of clinical research at Sierra Eye Associates, Reno, Nev. “As a C5 inhibitor, Izervay has shown to slow GA progression by targeting the source of retinal cell death and may preserve the upstream benefits of the complement system. The FDA approval of Izervay is great news for the retina community and our patients suffering from GA.”
“Geographic atrophy can severely limit people’s ability to drive, read, and see the faces of their family and friends,” said Jason Menzo, chief executive officer, Foundation Fighting Blindness. “This new treatment offers our patient community an important therapeutic option to potentially extend their ability to maintain independence.”
