> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Astellas Wins Revised Label for Izervay
- URL: https://www.fdaweb.com/astellas-wins-revised-label-for-izervay/
- Published: 2025-02-13T12:00:00.000Z
- Updated: 2026-09-14T14:53:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158655

FDA has approved an Astellas Pharma supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) that revises the labeling for the drug’s use in treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The approval cover’s Izervay’s use without a limitation on duration of dosing, according to the company. It was based on positive two-year data from the [GATHER2](https://www.astellas.com/en/news/28646?ref=fdaweb.com) Phase 3 clinical trial, which evaluated the efficacy and safety of monthly and every other month dosing through two years, it says.

In 11/2024, FDA issued Astellas a complete response letter on the supplemental NDA, which at the time the company said the concerns were “unrelated to the safety and benefit/risk of the use of Izervay; rather, the comments \[in the CRL\] focused on a statistical matter related to labeling language proposed by Astellas.”

Izervay was originally approved 8/2023 for treating GA secondary to AMD. As AMD progresses, retinal cell loss and the underlying blood vessels in the macula results in “marked thinning and atrophy of retinal tissue,” the company says. “Geographic atrophy, associated with AMD, leads to further irreversible loss of vision in these patients.”