Astellas announces FDA approval for Izervay for GA treatment
Betsy Goodfellow | August 7, 2023 | News story | Medical Communications | AMD, Astellas Pharma, FDA, Izervay, Opthalmology, geographic atrophy
Astellas Pharma has announced that the US Food and Drug Administration (FDA) has approved Izervay (avacincaptag pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Izervay is now the only approved GA treatment with a statistically significant reduction in the rare of GA progression at the 12-month primary endpoint, demonstrated in two phase 3 clinical trials.
This approval was based on results from the GATHER1 and GATHER2 phase 3 clinical trials, both of which evaluated the safety and efficacy of monthly 2mg intravitreal administration of the drug in patients with GA secondary to AMD. In both trials, showing of disease progression was observed at six months with up to 35% reduction within a year of treatment.
Pravin U Dugel, MD, president of Iveric Bio, an Astellas company, commented: “We are thrilled to receive FDA approval of Izervay and to offer a new therapy to physicians and appropriate patients in the US. 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.”
Arshad M Khanani, MD MA FASRS, director of clinical research at Sierra Eye Associates, added: “Geographic atrophy has a devastating impact on patients’ lives and can lead to irreversible vision loss. 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.”
Betsy Goodfellow
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