The US Food and Drug Administration (FDA) has approved an expanded label for Izervay (avacincaptad pegol intravitreal solution; Astellas Pharma), removing limitations on treatment duration for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The decision provides physicians and patients with greater flexibility in managing the progressive disease, Astellas said in a press release.

The approval follows Astellas’s resubmission of a supplemental New Drug Application (sNDA) in December 2024, shortly after addressing concerns raised in the FDA’s Complete Response Letter issued the previous month. The label expansion was supported by data from the GATHER2 phase 3 trial, which demonstrated that Izervay slowed GA lesion growth over 2 years compared to sham.

Since its launch in 2023, Izervay has become a widely used treatment for GA, with over 210,000 vials distributed by the end of 2024. A permanent J-code, J2782, became effective on April 1, 2024. Safety data from postmarketing reports remain consistent with clinical trial findings, with no new safety concerns identified. Izervay is the only FDA-approved treatment to show statistically significant slowing of GA progression in 2 pivotal studies.