ARVO and RWC abstracts feature analyses on biomarkers, mechanism of disease,

ARVO 和 RWC 摘要包括对生物标志物、疾病机制的分析，

patient experience and other data from IZERVAY

来自IZERVAY的患者体验和其他数据

TM

商标

(avacincaptad pegol intravitreal solution) pivotal studies

（玻璃体注射用阿瓦辛卡普塔德聚乙二醇溶液）关键研究

TOKYO, May 1, 2025

东京，2025年5月1日

– Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), maker of IZERVAY

– 安斯泰来制药株式会社（东京证券交易所代码：4503，总裁兼首席执行官：冈村直树，“安斯泰来”），IZERVAY 的制造商

TM

商标

(avacincaptad pegol intravitreal solution), a C5 inhibitor for the treatment of geographic atrophy (GA)

（阿伐辛卡普塔德聚乙二醇玻璃体内注射液），一种用于治疗地图状萎缩（GA）的C5抑制剂

*

*

, will highlight new data that enhances continued understanding of the science of GA, and the experience of patients living with the progressive disease at the Association for Research in Vision and Ophthalmology Annual Meeting (ARVO), May 4-8, Salt Lake City, Utah, and Retina World Congress (RWC), May 8-11, Fort Lauderdale, Florida..

，将在视觉与眼科研究协会年会（ARVO）和视网膜世界大会（RWC）上重点展示增强对地理萎缩（GA）科学理解的新数据，以及患有这种进行性疾病患者的体验。ARVO会议将于5月4日至8日在犹他州盐湖城举行，RWC会议将于5月8日至11日在佛罗里达州劳德代尔堡举行。

The data comprises nine abstracts, including two oral presentations, featuring analyses on biomarkers, patient experience, mechanism of disease and other insights from the GATHER Phase 3 studies of IZERVAY for the treatment of GA secondary to age-related macular degeneration (AMD).

数据包括九份摘要，其中两份为口头报告，内容涵盖生物标志物、患者体验、疾病机制以及 IZERVAY 治疗与年龄相关性黄斑变性（AMD）继发的 GA 的 GATHER 3 期研究中的其他见解。

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

马西·英格利希，安斯泰来制药公司高级副总裁，生物制药与眼科开发部门

“Recognizing the early indicators and disease pathways of geographic atrophy are critical to helping patients preserve their existing vision for longer. We look forward to engaging with the retina community at ARVO and RWC to discuss the latest scientific insights in early diagnosis and effective management of GA.”.

“识别地理性萎缩的早期指标和疾病途径对于帮助患者更长时间地保留现有视力至关重要。我们期待在ARVO和RWC与视网膜社区交流，讨论关于GA早期诊断和有效管理的最新科学见解。”

Research highlights include:

研究亮点包括：

An oral presentation on the structure-function relationship between baseline central subfield ellipsoid zone (EZ) integrity and visual acuity at baseline and future vision loss

关于基线中央子区椭球带（EZ）完整性与基线及未来视力丧失之间的结构-功能关系的口头报告

An oral presentation on baseline EZ integrity features linked to GA progression in eyes with differential shifts in GA growth rate

关于与GA进展相关的眼部基线EZ完整性特征的口头报告，这些特征与GA生长速率的差异变化有关。

Multiple posters evaluating imaging data from the GATHER1 and GATHER2 studies, which link structure and function in GA

多张海报评估了来自GATHER1和GATHER2研究的成像数据，这些数据将GA中的结构和功能联系起来。

Two preclinical posters with structural insights refining the mechanism of action, as well as pharmacokinetics and pharmacodynamics, of avacincaptad pegol (ACP)

两份临床前海报提供了对阿瓦辛卡普特聚乙二醇（ACP）作用机制、药代动力学和药效学的结构见解。

Data from qualitative studies assessing the experience of patients with GA in the U.S., Spain, Germany and France, including the impact of disease symptoms on health-related quality of life (HRQoL) and coping mechanisms used to manage symptoms of GA

评估美国、西班牙、德国和法国GA患者经历的定性研究数据，包括疾病症状对健康相关生活质量（HRQoL）的影响以及用于管理GA症状的应对机制。

Astellas Presentations at 2025 ARVO Annual Meeting

安斯泰来在2025年ARVO年会上的演讲

Presentation Title

标题页

Presenter

主持人

Presentation Details

演示详情

Association of baseline central subfield ellipsoid zone integrity with baseline visual acuity and future vision loss in the GATHER clinical trials

基线中央子区椭球带完整性与基线视力和未来视力丧失在GATHER临床试验中的关联

R. Amine

R. 阿明

Type:

类型：

Oral

口服

Presentation Number:

演示编号：

4594

4594

Date:

日期：

May 7, 2025 3:30-3:45 PM MT

2025年5月7日 下午3:30-3:45（山地时间）

Understanding the experience of people living with geographic atrophy in the United States, Spain, France and Germany

了解生活在美国、西班牙、法国和德国的地理性萎缩患者的经历

N. Genova

热那亚

Type:

类型：

Poster

海报

Posterboard Number:

海报板编号：

807 - B0259

807 - B0259

Date:

日期：

May 4, 2024 1:00-2:45 PM MT

2024年5月4日 下午1:00-2:45（山地时间）

Structural insights into the mechanism of inhabitation of C5 activation by avacincaptad pegol, an aptamer approved for the treatment of geographic atrophy secondary to age-related macular degermation

关于阿瓦辛卡普特聚乙二醇（avacincaptad pegol）抑制C5激活机制的结构学见解，该适配体已被批准用于治疗与年龄相关性黄斑变性相关的地理萎缩。

G. Musada

穆萨达

Type:

类型：

Poster

海报

Presentation Posterboard Number:

展示海报板编号：

2522 - B0235

2522 - B0235

Date:

日期：

May 5, 2025 3:00 – 4:45 PM MT

2025年5月5日 下午3:00 – 4:45（山地时间）

Nonclinical pharmacology and pharmacokinetic properties of avacincaptad pegol, an aptamer against C5 approved for the treatment of geographic atrophy secondary to age-related macular degeneration

针对C5的适配体药物Avacincaptad Pegol的非临床药理学和药代动力学特性，该药物已被批准用于治疗与年龄相关性黄斑变性继发的地图样萎缩。

N. Lombardi

N. 伦巴第

Type:

类型：

Poster

海报

Posterboard Number:

海报板编号：

2539 - B0252

2539 - B0252

Date:

日期：

May 5, 2025 3:00 – 4:45 PM MT

2025年5月5日 下午3:00 – 4:45（山地时间）

iRORA phenotype characterization using fundus autofluorescence: GATHER2 post-hoc analysis for geographic atrophy secondary to AMD

使用眼底自发荧光对iRORA表型进行特征分析：针对AMD继发性地理萎缩的GATHER2事后分析

G. Corradetti

G. 科拉代蒂

Type:

类型：

Poster

海报

Posterboard Number:

海报板编号：

3468 - B0031

3468 - B0031

Date:

日期：

May 6, 2025 1:15 – 3:00 PM MT

2025年5月6日 下午1:15 – 3:00（山地时间）

Association of ellipsoid zone integrity features with diffuse trickling fundus autofluorescence patterns in the GATHER1/GATHER2 clinical trials

GATHER1/GATHER2临床试验中椭球带完整性特征与弥漫性渗漏眼底自发荧光模式的关联

L. Della Vecchia

L. 德拉·维基亚

Type:

类型：

Poster

海报

Posterboard Number:

海报板编号：

3512 - B0075

3512 - B0075

Date:

日期：

May 6, 2025 1:15 – 3:00 PM MT

2025年5月6日 下午1:15 – 3:00（山地时间）

Structure-function link between ellipsoid zone integrity features and visual acuity in eyes with geographic atrophy in the GATHER1 and GATHER2 clinical trials

GATHER1和GATHER2临床试验中椭球区完整性特征与地理萎缩眼视力之间的结构功能联系

K. Matar

K. 马塔尔

Type:

类型：

Poster

海报

Posterboard Number:

海报板编号：

4123 - A0121

4123 - A0121

Date:

日期：

May 7, 2025 10:15 AM – 12:00 PM MT

2025年5月7日 上午10:15 - 中午12:00（山地时间）

Ellipsoid zone integrity features linked to differential shifts in geographic atrophy growth rate in the GATHER1 and GATHER2 clinical trials

GATHER1和GATHER2临床试验中，椭球体区域完整性特征与地理萎缩增长率的差异变化相关

A. Indurkar

A. Indurkar

Type:

类型：

Poster

海报

Posterboard Number:

展板编号：

4220 - A0218

4220 - A0218

Date:

日期：

May 7, 2025

2025年5月7日

10:15 AM – 12:00 PM MT

上午10:15 - 中午12:00（山地时间）

Astellas Presentations at RWC 2025 Meeting

安斯泰来在RWC 2025会议上的演讲

Presentation Title

演示标题

Presenter

主持人

Presentation Details

演示详情

Ellipsoid zone integrity features linked to differential shifts in geographic atrophy growth rate in the GATHER1 and GATHER2 clinical trials

在GATHER1和GATHER2临床试验中，椭球区完整性特征与地理萎缩增长率的差异变化相关

R. Downes

R. 唐斯

Type:

类型：

Oral

口服

Date:

日期：

May 9, 2025 2:38 – 2:43 pm ET

2025年5月9日 下午2点38分至2点43分（美国东部时间）

*

*

avacincaptad pegol intravitreal solution (ACP) is approved for use as IZERVAY

avacincaptad pegol玻璃体内注射溶液（ACP）被批准作为IZERVAY使用。

TM

商标

only in the U.S.

仅限美国。

About IZERVAY

关于IZERVAY

TM

商标

(avacincaptad pegol intravitreal solution)

（阿瓦辛卡普塔德聚乙二醇玻璃体内注射液）

INDICATION AND IMPORTANT SAFETY INFORMATION

适应症和重要的安全信息

What is IZERVAY

什么是IZERVAY

TM

商标

?

？

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（玻璃体内注射用阿伐辛卡肽）是一种处方眼注射剂，用于治疗地理性萎缩（GA），即干性年龄相关性黄斑变性（AMD）的晚期形式。

What is the most important information I should know about IZERVAY?

我应该了解的关于IZERVAY的最重要的信息是什么？

Do NOT receive IZERVAY if you:

如果您：请勿接受IZERVAY

Have an infection in or around your eye

眼睛或眼睛周围有感染

Have active swelling in or around your eye that may include pain and redness

眼睛或眼睛周围有活动性肿胀，可能伴有疼痛和发红。

IZERVAY can cause serious side effects:

IZERVAY 可能导致严重的副作用：

Eye injections like the one for IZERVAY can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment).

像IZERVAY这样的眼部注射可能会导致眼部感染（眼内炎）或视网膜层分离（视网膜脱离）。

Call your healthcare provider right away if you have redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small specks floating in your vision, flashes of light, or increased sensitivity to light.

如果出现眼睛红肿、眼痛、不适感加重、眼睛红肿恶化、视力模糊或下降、视野中出现更多小斑点、光闪或对光敏感度增加，请立即联系您的医疗保健提供者。

There is a risk of developing wet AMD with IZERVAY. You should report any symptoms (visual distortions such as straight lines seeming bent, deterioration in vision, dark spots, loss of central vision) to your healthcare provider to monitor.

使用IZERVAY有发展为湿性AMD的风险。你应该向你的医疗保健提供者报告任何症状（如直线看起来弯曲的视觉扭曲、视力恶化、暗点、中央视力丧失），以便进行监测。

IZERVAY may cause a temporary increase in eye pressure after the injection. Your healthcare provider will monitor this after each injection.

IZERVAY 注射后可能会导致眼压暂时升高。您的医疗保健提供者将在每次注射后对此进行监测。

Before receiving IZERVAY tell your healthcare provider about all of your medical conditions including if you:

在使用IZERVAY之前，请告知您的医疗保健提供者您的所有健康状况，包括：

Have a history of seeing flashes of light or small specks floating in your vision and if you have a sudden increase of size and number of these specks.

有看到闪光或小斑点在视野中漂浮的历史，如果这些斑点的大小和数量突然增加。

Have high pressure in the eye or if you have glaucoma.

眼压高或患有青光眼。

Are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

如果您怀孕或哺乳，认为自己可能怀孕，或计划生孩子，请在服用此药前咨询医生。

Are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your healthcare provider about any medicine you take.

正在服用任何药物，包括处方药和非处方药、维生素以及草药补充剂。告诉您的医疗保健提供者您所服用的任何药物。

What should I avoid while receiving IZERVAY?

我在接受IZERVAY治疗时应该避免什么？

Your vision may be impaired after receiving an eye injection or after an eye exam. Do not drive or use machinery until your vision has recovered sufficiently.

接受眼部注射或眼科检查后，您的视力可能会受到影响。在视力充分恢复之前，请勿驾驶或使用机械。

What are the most common side effects of IZERVAY?

IZERVAY最常见的副作用是什么？

Blood in the white of the eye

眼白出血

Increase in eye pressure

眼压升高

Blurred vision

视力模糊

Wet age-related macular degeneration

湿性年龄相关性黄斑变性

These are not all the possible side effects of IZERVAY. Tell your healthcare provider about any side effect that bothers you or that does not go away.

这些并非 IZERVAY 的所有可能副作用。如果出现任何困扰您或持续不消退的副作用，请告知您的医疗保健提供者。

Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit

如需了解有关副作用的医疗建议，请咨询您的医疗服务提供者。我们鼓励您向 FDA 报告处方药的负面副作用。访问

www.fda.gov/medwatch

www.fda.gov/medwatch

, or call 1-800-FDA-1088.

，或者拨打1-800-FDA-1088。

Please see full

请查看完整内容

Prescribing Information

处方信息

for more information.

欲了解更多信息。

About Geographic Atrophy

关于地理萎缩病变

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) 是导致老年成人中度至重度中心视力丧失的主要原因，在大多数患者中会影响双眼。黄斑是视网膜中央部分负责中心视力的一小块区域。随着 AMD 的进展，黄斑区视网膜细胞和下方血管的丧失会导致视网膜组织显著变薄和/或萎缩。

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

与AMD相关的地理萎缩会导致这些患者进一步不可逆的视力丧失。

About the GATHER Clinical Trials

关于GATHER临床试验

IZERVAY met its primary endpoint in the GATHER1 (

IZERVAY在GATHER1中达到了主要终点 (

NCT02686658

NCT02686658

) clinical trial and the GATHER2 (

) 临床试验和 GATHER2 (

NCT04435366

NCT04435366

) clinical trial, both of which were randomized, double-masked, sham-controlled, multicenter Phase 3 clinical trials. These trials evaluated the safety and efficacy of monthly 2 mg intravitreal administration of IZERVAY in patients with GA secondary to AMD. For the first 12 months in both trials, patients were randomized to receive either IZERVAY 2 mg or sham monthly.

）临床试验，这两项试验均为随机、双盲、假对照、多中心的三期临床试验。这些试验评估了每月2毫克玻璃体内注射IZERVAY在因AMD继发GA患者中的安全性和有效性。在两项试验的前12个月中，患者被随机分配每月接受IZERVAY 2毫克或假注射治疗。

There were 286 participants enrolled in GATHER1 and 448 participants enrolled in GATHER2. The primary efficacy endpoints in both pivotal studies were based on GA area measured by fundus autofluorescence at three time points: baseline, month 6, and month 12. Safety was evaluated in over 700 patients with GA across the two trials..

GATHER1 试验入组了 286 名参与者，GATHER2 试验入组了 448 名参与者。这两项关键研究的主要疗效终点基于通过眼底自荧光测量的 GA 区域，评估的时间点为基线、第 6 个月和第 12 个月。两项试验中超过 700 名 GA 患者的安全性得到了评估。

In year 2 of the GATHER2 study, patients treated with IZERVAY in year 1 were re-randomized to receive either IZERVAY 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GATHER2研究的第二年，第一年接受IZERVAY治疗的患者被重新随机分配接受每月一次（EM，n=96）或每隔一月一次（EOM，n=93）的IZERVAY治疗；第一年接受假手术的患者在第二年继续接受假手术（n=203）。IZERVAY正在一项开放标签延展研究中继续评估。

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.

安斯泰来是一家全球生命科学公司，致力于将创新科学转化为对患者的 VALUE。我们在肿瘤学、眼科、泌尿科、免疫学和妇女健康等疾病领域提供变革性疗法。通过我们的研究和开发项目，我们正在为那些存在高度未满足医疗需求的疾病开拓新的医疗解决方案。

Learn more at .

了解更多，请访问。

www.astellas.com

www.astellas.com

.

。

Cautionary Notes

注意事项

In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties.

在本新闻稿中，关于当前计划、估算、策略和信念的陈述以及其他非历史事实的陈述是关于安斯泰来未来业绩的前瞻性陈述。这些陈述基于管理层当前的假设和信念，并结合其目前可获得的信息，涉及已知和未知的风险与不确定性。

A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.

可能导致实际结果与前瞻性陈述中讨论的结果存在重大差异的因素包括但不限于：(i) 与医药市场相关的总体经济状况、法律法规的变化，(ii) 汇率波动，(iii) 新产品发布的延迟，(iv) 安斯泰来无法有效销售现有和新产品，(v) 安斯泰来无法在竞争激烈的市场中继续有效研发客户认可的产品，以及 (vi) 第三方侵犯安斯泰来的知识产权。

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice..

本新闻稿中包含的关于药品（包括正在开发中的产品）的信息，不旨在构成广告或医疗建议。

Click below for a copy of the full press release

点击下方获取完整新闻稿的副本