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Astellas company, Iveric Bio receives US FDA approval for Izervay to treat geographic atrophy

Astellas Pharma Inc. announced the US 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.Pravin U. Dugel, MD, president, Iveric Bio, An Astellas company, said: "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."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, 6 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 6 months with up to a 35% reduction in the first year of treatment.Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research at Sierra Eye Associates, Reno, Nevada, said: "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."GA impacts an estimated 1.5 million people in the US. However, approximately 75% of people living with GA in the US are believed to be undiagnosed.  Without timely treatment, an estimated 66% of people with GA may become blind or severely visually impaired.Jason Menzo, chief executive officer, Foundation Fighting Blindness, said: "Geographic atrophy can severely limit people's ability to drive, read, and see the faces of their family and friends. This new treatment offers our patient community an important therapeutic option to potentially extend their ability to maintain independence."Across the GATHER clinical trial program, the most common adverse reactions (= 5%) reported at 12 months in patients who received Izervay 2 mg were conjunctival haemorrhage (bleeding beneath the clear lining of the eye: 13%), intraocular pressure (increased fluid pressure of the eye: 9%) and blurred vision (8%).Izervay is anticipated to be available in the US in 2-4 weeks.Astellas is reviewing potential financial impacts of this approval for the fiscal year ending March 31, 2024.Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, associated with AMD, leads to further irreversible loss of vision in these patients.Izervay met its primary endpoint in the GATHER1 (NCT02686658) clinical trial and the GATHER2 (NCT04435366) clinical trial, both of which were randomized, double-masked, sham-controlled, multicenter phase 3 clinical trials. These trials evaluated the safety and efficacy of monthly 2 mg intravitreal administration of Izervay in patients with GA secondary to AMD. For the first 12 months in both trials, patients were randomized to receive either Izervay 2 mg or sham monthly. There were 286 participants enrolled in GATHER1 and 448 participants enrolled in GATHER2. The primary efficacy endpoints in both pivotal studies were based on GA area measured by fundus autofluorescence at three time points: baseline, month 6, and month 12. Safety was evaluated in over 700 patients with GA across the two trials.Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world.Iveric Bio, An Astellas company, is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs.