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# Astellas Eye Drug Approved by FDA
- URL: https://www.fdaweb.com/astellas-eye-drug-approved-by-fda/
- Published: 2023-08-07T12:00:00.000Z
- Updated: 2026-09-14T18:48:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155040

FDA has approved Astellas Pharma’s Izervay (avacincaptad pegol intravitreal solution) for treating geographic atrophy (GA) secondary to age-related macular degeneration (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.”

Approval was based on data from the [GATHER1](https://c212.net/c/link/?t=0&l=en&o=3937369-1&h=3265072395&u=https%3A%2F%2Fwww.aaojournal.org%2Farticle%2FS0161-6420%252820%252930845-9%2Ffulltext%3Fdgcid%3Draven%5Fjbs%5Faip%5Femail&a=GATHER1&ref=fdaweb.com) and [GATHER2](https://c212.net/c/link/?t=0&l=en&o=3937369-1&h=3072926612&u=https%3A%2F%2Finvestors.ivericbio.com%2Fnews-releases%2Fnews-release-details%2Fiveric-bio-announces-positive-topline-data-zimurar-gather2-phase&a=GATHER2&ref=fdaweb.com) Phase 3 clinical trials, which evaluated the safety and efficacy of monthly 2 mg intravitreal administration of Izervay in patients with GA secondary to AMD. Data showed a statistically significant reduction (p<0.01) in the rate of GA progression at the 12-month primary endpoint across the two trials, according to the company.