Izervay™ Approved to Treat Geographic Atrophy, Secondary to Age-Related Macular Degeneration
Astellas Pharma Inc. has announced that 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) on August 4, 2023. 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.
GA impacts an estimated 1.5 million people in the U.S. However, approximately 75% of people living with GA in the U.S. are believed to be undiagnosed. Without timely treatment, an estimated 66% of people with GA may become blind or severely visually impaired.
Izervay is contraindicated in patients with ocular or periocular infections and in patients with active intraocular inflammation. Izervay is anticipated to be available in the U.S. in 2-4 weeks.
