Astellas Reports Long-Term Efficacy of Izervay in GA

Astellas Pharma has announced new findings from the open-label extension (OLE) trial of the Phase 3 GATHER2 study, showing that long-term monthly treatment with Izervay (avacincaptad pegol intravitreal solution) continues to slow the progression of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) for up to 3.5 years.

The data, presented during Retina Subspecialty Day at the American Academy of Ophthalmology (AAO) 2025 Annual Meeting in Orlando, confirm the sustained efficacy and favorable safety profile of Izervay in long-term use.

GATHER2 OLE Trial: Long-Term Efficacy Maintained Up to 3.5 Years

In this 18-month open-label extension trial, patients who previously completed the GATHER2 study were transitioned to monthly Izervay treatment, regardless of their prior treatment assignment. Key results demonstrated:

• 40.5% reduction in GA lesion growth vs. projected sham in patients originally treated with Izervay (monthly or every-other-month) and switched to monthly dosing

• 37% reduction vs. projected sham in patients initially receiving sham who switched to monthly Izervay (P<0.001 for both)

Notably, patients who began treatment earlier had greater preservation of retinal tissue:

• 2.92 mm² preserved in the continuous Izervay group

• 1.83 mm² preserved in those who began treatment later

Izervay continued to show strong tolerability, with no new safety signals, no cases of retinal or occlusive vasculitis, and no increased risk of intraocular inflammation over the extended period.

“The first reported findings from this open-label extension study corroborate the favorable efficacy and safety outcomes previously demonstrated in the 2-year GATHER2 trial,” said Dr. Arshad M. Khanani, Director of Clinical Research at Sierra Eye Associates. “The most pronounced benefits are seen in patients who begin treatment earlier.”

Real-World Data Confirms Safety and Tolerability of Izervay in Clinical Practice

Complementing the trial results, a real-world observational study using the AAO IRIS Registry evaluated 10,181 patients (13,391 eyes) treated with Izervay during its first year of clinical use in the U.S. The analysis supported Izervay’s safety and tolerability:

• Mean treatment interval: 7.0 weeks (among eyes with ≥2 injections; n=11,799)

• 87.1% of patients had bilateral GA

• 68.5% received treatment in only one eye

• 22.7% of treated eyes also received anti-VEGF therapy (with nearly 90% having prior anti-VEGF exposure)

• 3.6% of patients (2.9% of eyes) experienced an adverse event within 25 weeks, translating to 103 events per 10,000 injections

“Izervay continues to be a trusted treatment option for countless patients living with GA and the fear of vision loss,” said Marci English, Senior VP of Biopharma and Ophthalmology Development at Astellas. “The ongoing research and data continue to suggest the crucial need for earlier detection and intervention to support patients in their journey to preserve their vision for as long as possible."

Post Hoc Analysis Links Structural Preservation to Functional Outcomes

In a separate presentation at AAO 2025, Astellas shared insights from a post hoc analysis pooling data from the GATHER1 and GATHER2 trials, examining the relationship between retinal structure and visual function in GA patients.

Key findings:

• Izervay slowed the loss of ellipsoid zone (EZ) signal intensity, a marker of photoreceptor health, over 18 months

• Benefit was more significant in patients with greater baseline low luminance deficit (LLD)

• Results reinforce EZ integrity and LLD as valuable biomarkers for GA progression

• LLD may be a more sensitive functional measure than best-corrected visual acuity (BCVA) in evaluating GA treatments

Izervay is currently approved for the treatment of GA in the United States, Australia, and conditionally in Japan.