Astellas Reports Long-Term Benefits and Strong Safety Profile for IZERVAY™ in Geographic Atrophy
GATHER2 extension data show sustained efficacy and no new safety concerns after 3.5 years of treatment.
Astellas Pharma Inc. (TSE: 4503) announced promising long-term data for its therapy IZERVAY™ (avacincaptad pegol intravitreal solution), demonstrating continued benefit in slowing the progression of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Results from the open-label extension of the Phase 3 GATHER2 study, presented at the American Academy of Ophthalmology (AAO) 2025 Annual Meeting in Orlando, showed that IZERVAY reduced GA lesion growth by up to 40.5% versus projected sham over 3.5 years of treatment. Importantly, the findings revealed that earlier initiation of IZERVAY therapy resulted in greater protection of retinal tissue, underscoring the importance of early intervention in GA management.
IZERVAY continued to demonstrate a strong safety profile, with no new safety signals and no cases of retinal vasculitis or occlusive vasculitis reported during the 18-month open-label extension period.
“These findings corroborate the favorable efficacy and safety outcomes previously observed in the two-year GATHER2 trial,” said Dr. Arshad M. Khanani, Director of Clinical Research at Sierra Eye Associates. “IZERVAY maintains a consistent safety profile and offers meaningful long-term reductions in disease progression, particularly when started earlier.”
In parallel, real-world data from more than 10,000 GA patients in the American Academy of Ophthalmology IRIS® Registry supported the drug’s safety and tolerability. The analysis found low discontinuation rates, low incidence of adverse events (3.6%), and an average treatment interval of seven weeks between injections, confirming that IZERVAY’s benefits in clinical studies are reflected in everyday clinical practice.
“IZERVAY continues to be a trusted treatment option for countless patients living with GA and the fear of vision loss,” said Marci English, Senior Vice President, Biopharma and Ophthalmology Development at Astellas. “Our ongoing research underscores the need for early detection and intervention to preserve vision for as long as possible.”
Additional findings presented at AAO 2025 linked structural changes in the retina to functional outcomes in GA patients treated with IZERVAY. Astellas researchers demonstrated that treatment slowed photoreceptor loss, reinforcing the structure-function relationship between ellipsoid zone (EZ) integrity and visual function, as measured by low luminance deficit (LLD). These biomarkers could help clinicians track disease progression and treatment impact more precisely.
IZERVAY is approved for the treatment of geographic atrophy in the United States, Australia, and conditionally in Japan, with Astellas continuing to work with regulatory agencies worldwide to expand access to patients globally.
About IZERVAY™ (avacincaptad pegol intravitreal solution)
IZERVAY is an intravitreal therapy designed to slow the progression of geographic atrophy, the advanced form of dry AMD. It is administered by eye injection and works by targeting complement protein C5, a key component in the inflammatory pathway implicated in GA progression.
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BioFocus Newsroom