#Japan #Tokyo #Astellas Pharma #IZERVAY #Geographic Atrophy

Groundbreaking Results from the GATHER2 Extension Study on IZERVAY™

Astellas Pharma Inc. recently unveiled promising data from the open-label extension of its Phase 3 GATHER2 study concerning IZERVAY™ (avacincaptad pegol intravitreal solution). The findings suggest that this treatment significantly slows the progression of geographic atrophy (GA), a serious form of age-related macular degeneration (AMD). The results indicate a robust reduction in GA growth ranging from 37% to 40.5% compared to projected sham treatments. The more proactive the intervention, the greater the protection of retinal tissue, stressing the importance of timely treatment.

Study Highlights

During the 18-month open-label extension trial, those initially involved in the GATHER2 study switched to receiving IZERVAY monthly. Notably, participants who began treatment earlier achieved better outcomes in retinal tissue preservation, showcasing a cumulative benefit over 3.5 years. Importantly, no new safety concerns emerged, and there were no detected cases of retinal vasculitis or occlusive vasculitis—a promising testament to the treatment's long-term safety profile.

Dr. Arshad M. Khanani, a leading clinical researcher, emphasized the results align with previous outcomes from the two-year GATHER2 trial, further affirming IZERVAY's efficacy. He remarked on the significant reduction of disease progression observed with early intervention, reinforcing the critical nature of initiating treatment sooner rather than later.

Real-World Evidence Supports Safety and Efficacy

Complementing the clinical study results, recent real-world data involving over 10,000 GA patients supports IZERVAY's tolerability and safety. According to data compiled from the American Academy of Ophthalmology IRIS® Registry, a mere 3.6% of patients experienced adverse events during the 25-week follow-up period, highlighting its suitability in a routine clinical setting. The study noted an average interval of 7 weeks between injections, with 68.5% of patients receiving treatment in one eye.

Marci English, Senior Vice President of Biopharma and Ophthalmology Development at Astellas, acknowledged the treatment's role as a reliable option for patients grappling with GA and potential vision loss. The evolving research continues to underline the significance of early detection and intervention, emphasizing how strategic treatment can help patients maintain their vision longer.

Structure-Function Link in Geographic Atrophy

Additionally, Astellas presented another revealing study at the American Academy of Ophthalmology 2025 Annual Meeting. This analysis explored the structural integrity of the ellipsoid zone (EZ) and low luminance deficit (LLD) in GA patients treated with IZERVAY. The findings suggest a strong correlation between the health of photoreceptors, indicated by EZ integrity, and overall visual performance, as measured by LLD.

Overall, the studies solidify IZERVAY’s position as a pivotal therapeutic option for individuals dealing with geographic atrophy due to AMD. With approvals granted in the United States and Australia, and ongoing discussions with global regulatory bodies, Astellas aims to expand access and deepen understanding of GA while enhancing patient care.

Conclusion

As our understanding of geographic atrophy deepens, innovations like IZERVAY continue to pave the way for improved outcomes in eye health. The recent data underscores the importance of early intervention and effective treatment strategies in preserving vision and enhancing the quality of life for patients worldwide.