Astellas Presents Long-Term Data Supporting Sustained Efficacy and Safety of Izervay in Geographic Atrophy

安斯泰来展示了支持Izervay在地理性萎缩中持续有效性和安全性的长期数据

October 21, 2025

2025年10月21日

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..

安斯泰来制药宣布了来自第 3 期 GATHER2 研究的开放标签扩展 (OLE) 试验的新发现，结果显示，长期每月使用 Izervay（阿伐辛肽玻璃体内注射液）治疗可持续减缓因年龄相关性黄斑变性 (AMD) 引发的地理性萎缩 (GA) 进展，最长可达 3.5 年。

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.

在奥兰多举行的美国眼科学会（AAO）2025年年会视网膜亚专科日上提交的数据证实了Izervay在长期使用中的持续有效性和良好的安全性。

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

GATHER2 OLE试验：长期疗效维持长达3.5年

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:

在此为期18个月的开放标签延长期试验中，之前完成GATHER2研究的患者不论之前的治疗分配如何，均转为每月接受Izervay治疗。关键结果表明：

• 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

• 与最初接受Izervay（每月或隔月一次）治疗后转为每月一次给药的患者相比，GA病灶增长减少了40.5%，相对于预计的假手术组

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

• 与最初接受假手术后转为每月使用Izervay的患者相比，减少37%（两者P<0.001）

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

值得注意的是，较早开始治疗的患者视网膜组织的保存更为完好：

• 2.92 mm² preserved in the continuous Izervay group

• 连续Izervay组中保留了2.92平方毫米

• 1.83 mm² preserved in those who began treatment later

• 1.83 mm² 在较晚开始治疗的人中得以保留

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.

Izervay继续显示出良好的耐受性，没有新的安全信号，没有视网膜或闭塞性脉管炎的病例，并且在延长期内没有增加眼内炎症的风险。

“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.”.

“这项开放标签扩展研究的首批报告结果证实了此前在为期两年的GATHER2试验中展示的良好疗效和安全性，”塞拉眼科协会临床研究主任阿尔沙德·M·卡汗尼博士表示。“治疗越早开始，患者获益越显著。”

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

真实世界数据证实Izervay在临床实践中的安全性和耐受性

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:

补充试验结果，一项使用AAO IRIS注册数据库的真实世界观察性研究评估了10,181名患者（13,391只眼），这些患者在美国临床使用的首年接受了Izervay治疗。分析支持了Izervay的安全性和耐受性：

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

• 平均治疗间隔：7.0周（在注射次数≥2次的眼中；n=11,799）

• 87.1% of patients had bilateral GA

• 87.1%的患者患有双侧GA

• 68.5% received treatment in only one eye

• 68.5%的患者仅单眼接受治疗

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

• 22.7%的治疗眼还接受了抗VEGF治疗（近90%曾有抗VEGF暴露史）

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

• 3.6% 的患者（2.9% 的眼睛）在 25 周内经历了不良事件，相当于每 10,000 次注射发生 103 次事件。

“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.'.

“伊泽维（Izervay）仍然是无数患有地理性萎缩（GA）和面临失明恐惧的患者信赖的治疗选择，”安斯泰来（Astellas）生物制药和眼科开发高级副总裁马西·英格利希（Marci English）表示。“持续的研究和数据继续表明，早期检测和干预对于帮助患者尽可能长时间地保护视力至关重要。”

Post Hoc Analysis Links Structural Preservation to Functional Outcomes

事后分析将结构保存与功能结果联系起来

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.

在AAO 2025的另一场报告中，安斯泰来分享了对GATHER1和GATHER2试验数据进行事后分析的结果，探讨了GA患者视网膜结构与视觉功能之间的关系。

Key findings:

主要发现：

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

• 在18个月内，Izervay减缓了椭圆体带（EZ）信号强度的下降，这是光感受器健康的一项指标。

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

• 对于基线低亮度缺失（LLD）较大的患者，获益更为显著。

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

• 结果强化了EZ完整性和LLD作为GA进展的有价值生物标志物

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

• 在评估GA治疗时，LLD可能比最佳矫正视力（BCVA）更为敏感。

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

Izervay目前已在美国、澳大利亚以及日本（有条件地）获批用于GA的治疗。