FDA Approves Extended Dosing for Astellas’ Izervay in Geographic Atrophy Treatment
The FDA has approved expanded prescribing information for Astellas Pharma's Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)17.
Izervay is now approved without a limitation on duration of dosing, providing greater flexibility for physicians and patients in managing GA17.
The approval follows Astellas' resubmission of the supplemental New Drug Application (sNDA) for Izervay on December 26, 202417.
The FDA's decision was based on positive results from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of Izervay through year 237.
Izervay demonstrated continued reduction in GA lesion growth compared to sham treatment, with benefits observed as early as 6 months and increasing over time37.
Since its initial approval in August 2023, Izervay has shown month-over-month growth in the U.S., with over 143,000 vials distributed through September 20247.
Izervay remains the only FDA-approved treatment to demonstrate a statistically significant slowing of GA across two pivotal studies37.
Sources:
1. https://www.thepharmaletter.com/wider-label-approved-for-izervay-by-fda
3. https://www.worldpharmaceuticals.net/news/fda-removes-dosing-limitation-for-astellas-izervay-in-geographic-atrophy-treatment/