– Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the U.S. Food and Drug Administration (FDA) approved expanded U.S. Prescribing information for IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

–Astellas Pharma Inc.（TSE:4503，总裁兼首席执行官：Naoki Okamura，“Astellas”）今天宣布，美国食品和药物管理局（FDA）批准扩大IZERVAY™的美国处方信息（avacincaptad pegol玻璃体内溶液），用于治疗继发于年龄相关性黄斑变性（AMD）的地理萎缩（GA）。

As a result, IZERVAY is now approved without a limitation on duration of dosing—providing physicians and patients with greater flexibility when managing GA..

因此，IZERVAY现在获得批准，不受给药持续时间的限制，为医生和患者在管理GA时提供了更大的灵活性。。

The approval follows Astellas’ resubmission of the supplemental New Drug Application (sNDA) for IZERVAY on December 26, 2024, within days of meeting with the FDA to clarify the Agency’s feedback provided in the

此次批准是在安斯泰来于 2024 年 12 月 26 日重新提交 IZERVAY 的补充新药申请 (sNDA) 之后的几天内进行的，此前安斯泰来曾与 FDA 会面以澄清该机构在2024 年 11 月发布的完整回复函 (CRL)中提供的反馈。

Marci English, Senior Vice President, Biopharma and Ophthalmology Development, Astellas Pharma

Marci English，Astellas Pharma生物制药和眼科发展高级副总裁

“We are pleased with the FDA’s decision to extend the use of IZERVAY for longer-term administration—further solidifying IZERVAY’s status as a trusted choice for thousands of GA patients since its launch in 2023. To date, IZERVAY remains the only FDA-approved treatment to demonstrate a statistically significant slowing of GA across two pivotal studies.”.

“我们很高兴FDA决定延长IZERVAY的长期使用，这进一步巩固了IZERVAY自2023年推出以来作为数千GA患者值得信赖的选择的地位。。

The approved label update was based on positive results from the

批准的标签更新是基于

GATHER2

GATHER2

Phase 3 clinical trial, which evaluated the efficacy and safety of IZERVAY through year 2.

第3阶段临床试验，评估了IZERVAY在第2年的疗效和安全性。

Since receiving a

自收到

permanent J-code

永久J代码

in April 2024, IZERVAY has had month-over-month growth in the U.S. with more than 143,000 vials distributed through the end of September 2024. Post-marketing safety reporting remains consistent with that observed in the clinical trial program, with no new or significant safety signals identified, providing confidence to prescribers in IZERVAY’s safety profile..

2024年4月，IZERVAY在美国的销量环比增长，截至2024年9月底，共销售了143000多瓶。。。

Veeral S. Sheth, MD, MBA, FACS, FASRS, Partner and Director of Clinical Trials University Retina

Veeral S.Sheth，医学博士、MBA、FACS、FASRS，大学视网膜临床试验合作伙伴兼主任

“This is a welcome update for retina specialists, providing continued management options for treatment of this chronic, progressive disease that can lead to irreversible vision loss.”

“这对视网膜专家来说是一个受欢迎的更新，为治疗这种可能导致不可逆转的视力丧失的慢性进行性疾病提供了持续的管理选择。”

The GATHER2 study demonstrated that IZERVAY continued to reduce the rate of GA lesion growth in patients with GA secondary to AMD through 2 years versus sham. The treatment benefit with IZERVAY versus sham was observed as early as 6 months, continued to increase over time through 2 years, and more than doubled over 2 years compared to year 1..

GATHER2研究表明，与假手术相比，IZERVAY在2年内继续降低继发于AMD的GA患者的GA病变增长率。IZERVAY与sham的治疗益处早在6个月时就观察到，随着时间的推移，在2年内持续增加，与第1年相比，在2年内增加了一倍多。。

IZERVAY was well tolerated over 2 years in GATHER2, with one case of non-serious intraocular inflammation and culture-positive endophthalmitis each, and zero cases of ischemic neuropathy or serious intraocular inflammation, including retinal vasculitis. Over 2 years, the incidence of choroidal neovascularization was slightly increased between IZERVAY (11.6%) versus sham (9%)..

GATHER2对IZERVAY的耐受性良好，2年内各有1例非严重眼内炎症和培养阳性眼内炎，0例缺血性神经病或严重眼内炎症，包括视网膜血管炎。超过2年，IZERVAY（11.6%）与sham（9%）之间脉络膜新生血管的发生率略有增加。。

IZERVAY was approved by the U.S. Food and Drug Administration on August 4, 2023, for the treatment of GA secondary to AMD.

IZERVAY 已获批准于2023年8月4日获得美国食品药品监督管理局批准，用于治疗继发于AMD的GA。

The impact of this matter on Astellas’ financial results for the fiscal year ending March 31, 2025, is expected to be minor.

预计此事对安斯泰来截至 2025 年 3 月 31 日的财年的财务业绩影响不大。

About IZERVAY™ (avacincaptad pegol intravitreal solution)

关于IZERVAY™（avacincaptad pegol玻璃体内溶液）

What is IZERVAY?

IZERVAY是什么？

IZERVAY (avacincaptad pegol intravitreal solution) is a prescription eye injection, used to treat geographic atrophy (GA), the advanced form of dry age-related macular degeneration (AMD).

IZERVAY（avacincaptad pegol玻璃体内溶液）是一种处方眼注射剂，用于治疗地理萎缩（GA），这是干性年龄相关性黄斑变性（AMD）的晚期形式。

About Geographic Atrophy

关于地理萎缩

Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue.

年龄相关性黄斑变性（AMD）是老年人中度和重度中央视力丧失的主要原因，影响大多数患者的双眼。黄斑是视网膜中央负责中央视力的一个小区域。随着AMD的进展，黄斑中视网膜细胞和底层血管的丢失会导致视网膜组织明显变薄和/或萎缩。

Geographic atrophy, associated with AMD, leads to further irreversible loss of vision in these patients..

与AMD相关的地理萎缩导致这些患者进一步不可逆转的视力丧失。。

About the GATHER2 Clinical Trial

关于GATHER2临床试验

GATHER2(NCT04435366) was a randomized, double-masked, sham-controlled, multicenter Phase 3 clinical trial to evaluate the safety and efficacy of intravitreal administration of avacincaptad pegol (ACP) in 448 enrolled patients with GA secondary to AMD. ACP met its primary objective at 12 months, for which patients were randomized to receive either ACP or sham procedure monthly.

GATHER2(NCT04435366)是一项随机，双盲，假对照，多中心的3期临床试验，旨在评估448例AMD继发GA患者玻璃体内注射avacincaptad pegol（ACP）的安全性和有效性。ACP在12个月时达到了其主要目标，为此患者被随机分配每月接受ACP或假手术。

In year 2 of the study, patients treated with ACP in year 1 were re-randomized to receive either ACP dosed monthly (EM, n=96) or every other month (EOM, n=93); patients who received sham in year 1 continued to receive sham in year 2 (n=203). IZERVAY is continuing to be evaluated in an open-label extension study..

在研究的第二年，第1年接受ACP治疗的患者被重新随机分配，每月（EM，n=96）或每隔一个月（EOM，n=93）接受ACP给药；。IZERVAY将继续在开放标签扩展研究中进行评估。。

About Astellas

关于安斯泰来

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.

Astellas是一家全球生命科学公司，致力于将创新科学转化为患者的价值。我们在包括肿瘤学、眼科、泌尿学、免疫学和女性健康在内的疾病领域提供变革性疗法。通过我们的研发计划，我们正在为医疗需求未得到满足的疾病开创新的医疗保健解决方案。