Astellas Pharma Inc. announced the U.S. Food and Drug Administration (FDA) approved IZERVAY? (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on August 4, 2023. IZERVAY, a new complement C5 inhibitor, is the only approved GA treatment with a statistically significant reduction (p<0.01) in the rate of GA progression at the 12-month primary endpoint across two Phase 3 clinical trials.

The FDA approval was based on the GATHER1 and GATHER2 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. The rate of GA growth was evaluated at baseline, 6 months, and 12 months. In each registrational trial, over a 12-month period, the primary analysis showed a statistically significant reduction in the rate of GA growth in patients treated with IZERVAY compared to sham.

Slowing of disease progression was observed as early as 6 months with up to a 35% reduction in the first year of treatment. Across the GATHER clinical trial program, the most common adverse reactions (= 5%) reported at 12 months in patients who received IZERVAY 2 mg were conjunctival hemorrhage (bleeding beneath the clear lining of the eye: 13%), intraocular pressure (increased fluid pressure of the eye: 9%) and blurred vision (8%). IZERVAY is anticipated to be available in the U.S. in 2-4 weeks.

Astellas is reviewing potential financial impacts of this approval for the fiscal year ending March 31, 2024.