FDA expands avacincaptad pegol labeling for geographic atrophy

The U.S. Food and Drug Administration (FDA) has approved an expanded U.S. Prescribing Information for avacincaptad pegol intravitreal solution (Izervay; Astellas) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), according to a press release.  The updated approval removes any limitation on the duration of dosing, offering greater flexibility for physicians and patients managing GA.

The decision follows Astellas’ resubmission of a supplemental New Drug Application (sNDA) on December 26, 2024, after addressing feedback from the FDA’s Complete Response Letter issued in November 2024.

“We are pleased with the FDA’s decision to extend the use of Izervay for longer-term administration—further solidifying Izervay’s status as a trusted choice for thousands of GA patients since its launch in 2023. To date, Izervay remains the only FDA-approved treatment to demonstrate a statistically significant slowing of GA across two pivotal studies,” Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma said.

This content is independent editorial sponsored by Astellas. Astellas had no input in the development of this content.