IZERVAY™ (avacincaptad pegol intravitreal solution) Showed Increased Benefit in Reducing Geographic Atrophy Progression Over Time and Consistent Long-Term Safety

In GATHER2 open-label extension study, IZERVAY reduced GA growth 37-40.5% vs. projected sham, with earlier intervention resulting in greater protection of retinal tissue area  

Study results found no new safety signals and no cases of retinal vasculitis or occlusive vasculitis after IZERVAY treatment of up to 3.5 years

New U.S. real-world data from more than 10,000 GA patients support safety and tolerability of IZERVAY with  low rates of discontinuation and adverse events

TOKYO, Oct. 19, 2025 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the first results from the open-label extension trial of the Phase 3 GATHER2 study, which demonstrated monthly treatment with IZERVAY™ (avacincaptad pegol intravitreal solution) in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) continued to reduce GA lesion growth for up to 3.5 years, with earlier intervention resulting in greater protection of retinal tissue area. IZERVAY was well tolerated, with no cases of retinal vasculitis or occlusive vasculitis. These findings, which indicate a cumulative treatment benefit with IZERVAY, were presented at the American Academy of Ophthalmology 2025 Annual Meeting (AAO 2025) during the Retina Subspeciality Day in Orlando, Fla.

During the 18-month open-label extension (OLE) trial, GA patients who previously completed the GATHER2 study switched from IZERVAY monthly (EM) or every-other-month (EOM) treatment to IZERVAY EM, or from sham to IZERVAY EM.

In the OLE study, disease progression, as measured by mean change in GA lesion growth area was reduced by 40.5% from month 24 (mm2/year) vs. projected sham in participants who switched from IZERVAY EM or EOM to IZERVAY EM at 3.5 years, and by 37% vs. projected sham in the IZERVAY EM group who previously received sham (p