Astellas Announces New Data Demonstrating Long-Term Efficacy of Izervay in Slowing GA Progression
Astellas Pharma announced the first results from the open-label extension (OLE) trial of the phase 3 GATHER2 study, which showed that monthly treatment with Izervay (avacincaptad pegol intravitreal solution) continued to slow disease progression in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) for up to 3.5 years. The findings, presented during Retina Subspecialty Day at the American Academy of Ophthalmology (AAO) 2025 annual meeting in Orlando, highlight sustained efficacy and favorable safety outcomes, reinforcing the long-term benefit of Izervay therapy.
In the 18-month OLE trial, patients who previously completed GATHER2 transitioned to monthly Izervay treatment, regardless of their initial study group assignment. The study demonstrated that disease progression, as measured by mean change in GA lesion growth area, was reduced by:
40.5% versus projected sham in patients who switched from Izervay monthly (EM) or every-other-month (EOM) to Izervay EM at 3.5 years
37% versus projected sham in patients who previously received sham and then switched to Izervay EM (P<0.001 for both comparisons).
Patients who initiated treatment earlier experienced greater protection of retinal tissue, with preserved retinal areas of 2.92 mm² in the continuous Izervay group and 1.83 mm² in those starting treatment later. Izervay was well tolerated, showing no new safety signals, no cases of retinal or occlusive vasculitis, and no increased risk of intraocular inflammation.
“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 Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research at Sierra Eye Associates and Clinical Professor at the University of Nevada, Reno. “Izervay maintains a consistent safety profile and is associated with meaningful reduction in disease progression over time, with the most pronounced benefits observed in patients who initiated treatment at an earlier stage.”
A separate real-world observational study based on data from the AAO IRIS Registry (Intelligent Research In Sight) evaluated 10,181 patients (13,391 eyes) treated with Izervay in routine US clinical practice during its first year following FDA approval. The analysis confirmed low rates of discontinuation and no new safety concerns, supporting the therapy’s safety and tolerability.
Key findings from the real-world analysis include:
Among eyes receiving at least two Izervay injections (n=11,799), the mean treatment interval was 7.0 weeks
87.1% of patients had bilateral GA, while 68.5% received treatment in one eye
22.7% of treated eyes also received anti-VEGF therapy, with nearly 90% of these patients having prior anti-VEGF exposure
3.6% of patients (2.9% of eyes) experienced any adverse event during the 25-week follow-up period, for an event rate of 103 per 10,000 injectio
“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, Astellas Pharma. “Our latest data highlight the importance of early detection and intervention to preserve vision, and we remain committed to deepening our understanding of GA to support patients on their journey.”
Structure-Function Relationship: New Insights from Post Hoc Analysis
Another Astellas presentation at AAO 2025 explored the relationship between retinal structure and visual function in GA using post hoc pooled data from the GATHER1 and GATHER2 studies. The analysis assessed ellipsoid zone (EZ) integrity—a marker of photoreceptor health—and low luminance deficit (LLD), an indicator of visual function. Results demonstrated that:
Treatment with Izervay slowed the loss of EZ signal intensity compared to sham over 18 months
The effect was most pronounced in eyes with greater baseline LLD, suggesting enhanced benefit in patients with more advanced disease
Findings reinforce EZ integrity and LLD as biomarkers for GA progression and indicate LLD may be a more sensitive measure of visual function than best-corrected visual acuity (BCVA)
Izervay is approved for the treatment of GA in the United States, Australia, and conditionally in Japan.