Avacincaptad pegol(Avacincaptad pegol) - 药物靶点：C5_在研适应症：地图样萎缩，年龄相关性黄斑变性，失明_专利_临床

概要

基本信息

药物类型

RNA aptamer

别名

Anti-C5 aptamer、Avacincaptad pegol sodium (USAN)、Zimura

+ [5]

靶点

C5

作用方式

抑制剂

作用机制

C5抑制剂(补体C5抑制剂)

治疗领域

遗传病与畸形眼部疾病神经系统疾病+ [1]

在研适应症

地图样萎缩年龄相关性黄斑变性失明+ [3]

非在研适应症

特发性息肉样脉络膜血管病湿性年龄相关性黄斑变性

原研机构

Ocular Therapeutix, Inc.

在研机构

IVERIC bio, Inc.Astellas Pharma Global Development, Inc.

Archemix Corp.

+ [3]

非在研机构

Ophthotech Corp. (New Jersey)

权益机构

DelSiTech Oy

Astellas Pharma, Inc.

Archemix Corp.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (2023-08-04),

地图样萎缩

最高研发阶段(中国)-

特殊审评突破性疗法 (美国)、优先审评 (美国)

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结构/序列

Sequence Code 29451050

来源: *****

关联

13

项与 Avacincaptad pegol 相关的临床试验

NCT06961370

/ Recruiting临床1期

A Phase I, Multi-center, Multi-part Study to Investigate Safety, Tolerability, PK, PD, and Immunogenicity of RO7669330 Intravitreal Injections in Participants With GA Secondary to AMD: Part 1A: Open-label, MAD; Part 1B: Randomized PD Pilot; Part 2: Masked, Randomized, Active-comparator-controlled

The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in GA secondary to AMD after multiple unilateral intravitreal (IVT) doses.

开始日期2025-07-16

申办/合作机构

Roche Holding AG

NCT06970665

/ Recruiting临床3期

A Phase 3/4, Multicenter, Single-arm Clinical Study to Assess the Safety of Intravitreal Administration of ASP3021 in Participants in Japan With Geographic Atrophy Secondary to Age-related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease which causes people to lose their vision over time. AMD damages the macula, which is in the middle of the retina - the light sensitive part at the back of the eye. In AMD, the cells in the macula die over time, usually over several years, leading to vision loss. When AMD gets worse, it can turn into either geographic atrophy (GA), neovascular AMD, or both.
This study is for people in Japan of 40 years of age or older, who have geographic atrophy.
The main aim of this study is to collect information about the safety of ASP3021 and how well people tolerate treatment with ASP3021.
During the study, people will receive monthly injections of ASP3021 for 12 months. ASP3021 is given by injection into the affected eye. This procedure is called an intravitreal injection.
People will be in the study for about 1 year. People will visit their study clinic several times for health checks.

开始日期2025-07-08

申办/合作机构

Astellas Pharma, Inc.

NCT06779773

/ RecruitingN/A

A Non-interventional, Observational Study to Evaluate Treatment Patterns and Safety of Avacincaptad Pegol (ACP/IZERVAY™) in Routine Clinical Practice in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

This study is for people who have geographic atrophy due to age-related macular degeneration (AMD). AMD happens when the macula, the light-sensitive layer at the back of the eye called the retina, becomes damaged and causes a person's central vision to worsen. Geographic atrophy is an advanced form of AMD where cells in the retina waste away and die. Over time this can lead to permanent loss of vision.
Avacincaptad pegol can help slow down the worsening or progression of geographic atrophy. Avacincaptad pegol is a treatment approved in the US to treat geographic atrophy.
This study is about collecting information on how people with geographic atrophy are treated in routine clinical practice. This includes recording any medical problems from avacincaptad pegol. This is known as an observational study. Information will be collected from the peoples' medical records during and after treatment. The people in this study will have geographic atrophy in 1 or both eyes and they and their doctor has decided they will be treated with avacincaptad pegol. The individual's doctor decides on treatment, not the study sponsor (Astellas).
People that want to take part in the study will have eye examinations that they would usually have as part of their routine care. People will also be asked to complete surveys about their eye health. These surveys will occur when treatment starts and then every 6 months for the first 2 years. After 2 years the surveys will happen once a year. The people on the study can take part if their doctor provides treatment with avacincaptad pegol and they want to continue with the study. The people on the study can take part for up to 3 years or up to 5 years, depending on when they start the study.

开始日期2025-01-22

申办/合作机构

Astellas Pharma Global Development, Inc.

100 项与 Avacincaptad pegol 相关的临床结果

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100 项与 Avacincaptad pegol 相关的转化医学

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100 项与 Avacincaptad pegol 相关的专利（医药）

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52

项与 Avacincaptad pegol 相关的文献（医药）

2025-08-01·AMERICAN JOURNAL OF OPHTHALMOLOGY

Ocular Adverse Events Associated with Pegcetacoplan and Avacincaptad Pegol for Geographic Atrophy: A Population-Based Pharmacovigilance Study

Article

作者: Kertes, Peter J ; Muni, Rajeev H ; Popovic, Marko M ; Mihalache, Andrew ; Kailani, Zeena

OBJECTIVE:

To evaluate the postmarketing ocular adverse events (AEs) reported for avacincaptad pegol and pegcetacoplan, the only Food and Drug Administration (FDA)-approved treatments for geographic atrophy (GA).

DESIGN:

Retrospective pharmacovigilance analysis.

SUBJECTS:

Ocular AE reports in the FDA Adverse Event Reporting System (FAERS) in which pegcetacoplan or avacincaptad pegol was identified as the primary suspect drug were analyzed.

METHODS:

Using the OpenVigil 2.1 data mining software, we conducted a retrospective pharmacovigilance analysis of the FAERS database from inception to December 2024. We conducted disproportionality analyses to assess reporting odds ratios (RORs) for specific drug-AE combinations compared with all other drugs in the database.

MAIN OUTCOME MEASURES:

Ocular AEs were evaluated.

RESULTS:

A total of 752 and 80 patients with AEs secondary to pegcetacoplan and avacincaptad pegol, respectively, were identified. Ocular AEs disproportionately overreported for pegcetacoplan included anterior segment (iris) hemorrhage (ROR 1767, 95% CI 538-5803), iris neovascularization (ROR 1248, 95% CI 502-3099), choroidal neovascularization (ROR 1328, 95% CI 956-1845), intraocular injection complication (ROR 2552, 95% CI 1607-4053), hemorrhagic occlusive retinal vasculitis (ROR 4606, 95% CI 2000-10,611), retinal occlusive vasculitis (ROR 2352, 95% CI 1313-4212), and bacterial endophthalmitis (ROR 1260, 95% CI 613-2589). Ocular AEs disproportionately overreported for avacincaptad pegol included choroidal neovascularization (ROR 1169, 95% CI 426-3205), vitritis (ROR 782, 95% CI 316-1936), dry age-related macular degeneration (ROR 684, 95% CI 316-1936), and cystoid macular edema (ROR 445, 95% CI 140-1412).

CONCLUSIONS:

Current prescribing patterns indicate that a broader spectrum of ocular AEs were reported for pegcetacoplan than avacincaptad pegol. These findings aim to enhance clinicians' understanding of the safety profiles of these agents, enabling informed patient care and heightened vigilance of these novel GA treatments.

2025-06-01·Ophthalmology and Therapy

Clinical Outcomes of Treatment of Geographic Atrophy: A Narrative Review

Review

作者: Torp, Thomas Lee ; Vergmann, Anna Stage ; Nissen, Anne Helene Køllund

RATIONALE:

In 2023, the U.S. Food and Drug Administration approved pegcetacoplan (SYFOVRE) as the first therapeutic option for geographic atrophy (GA), a previously untreatable condition associated with age-related macular degeneration. Following this, avacincaptad pegol (Izervay) was also approved for GA treatment, further expanding therapeutic options.

OBJECTIVES:

This article aims to give an overview of the clinical outcomes of GA treatment and to discuss which patient groups may benefit most from these therapies.

METHODS:

A review of the literature was conducted using the databases PubMed, Cochrane Library, and ClinicalTrials.gov. The search yielded six relevant studies.

CONCLUSIONS:

The management of geographic atrophy has advanced with therapies like pegcetacoplan and avacincaptad pegol showing clear benefits in slowing lesion growth. However, safety concerns, such as neovascular complications, persist. Photobiomodulation and dietary supplementation provide alternative options with modest benefits, particularly in the early stages. Larger studies are needed to confirm long-term safety, efficacy, and optimal treatment strategies.

2025-05-06·RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES

Silicone oil microdroplets from syringes with intravitreal anti-vascular endothelial growth factor and complement inhibitor injections

Article

作者: Wei, Libby ; Thompson, John T. ; Fan, Xiaoxuan ; Lee, Erica

Purpose::

To quantify the amount of silicone oil in intravitreal anti-vascular endothelial growth factor and complement inhibitor injections in prefilled and commercial syringes (silicone-lubricated and silicone-free).

Methods::

Patients deemed clinically appropriate to receive one of five intravitreal medications received the recommended dose. Syringes were overfilled such that 0.01-0.04mL remained after injection for analysis. Aflibercept and ranibizumab were available in prefilled syringes. Pegcetacoplan, faricimab, and avacincaptad pegol were prepared with Becton Dickinson polycarbonate (BD) syringes. Faricimab was also prepared in Ocuject VitreJect® (OV) silicone-free syringes. Samples were analyzed using spectral flow cytometry.

Results::

Silicone oil was found in all syringes. The lowest amounts of silicone oil were found in the Mili-Q water in OV syringes (4.02±0.3 particles per microliter) and ranibizumab 0.5 mg prefilled syringes (8.33±3.1). Intermediate levels of silicone oil were detected in aflibercept prefilled syringes (35.5±21.8) and faricimab in OV syringes (74.6±10.1), significantly greater than Mili-Q water in OV syringes and ranibizumab. Significantly higher levels of silicone oil were found with faricimab (324.9±30), pegcetacoplan (378.1±379.6), and avacincaptad pegol (113.5±14) in BD syringes than the low or intermediate groups. The filter needles used to draw up medications from vials likely contributed to the amount of silicone oil detected in the samples.

Conclusions::

Commonly used BD polycarbonate syringes for intravitreal injections caused significantly higher levels of silicone oil to be injected into the eye than prefilled or silicone free syringes. Repeated injections with more viscous intravitreal drugs increase the amount of silicone oil in the vitreous, leading to symptomatic floaters.

231

项与 Avacincaptad pegol 相关的新闻（医药）

2025-08-04

·GBIHealth

安斯泰来FY2025Q1：营收34.17亿美元，中国增长57.8%

近日，安斯泰来制药集团（TSE：4503）发布2025财年第一季度（FY2025Q1：2025年4月1日~2025年6月30日）全球财务业绩。报告期内公司录得营业收入5058亿日元（约34.17亿美元，GBI计算，下同），同比增长6.9%；核心营业利润为1423亿日元（9.61亿美元），同比增长61.1%。核心产品组合贡献了稳健的增长，包括：用于治疗尿路上皮癌的ADC维恩妥尤单抗（备思复/Padcev）销售额同比增长44.6%至555亿日元（3.75亿美元），用于治疗与年龄相关的黄斑变性所致地理萎缩的眼科药物Izervay销售额同比增长25.2%至159亿日元（1.07亿美元），用于治疗前列腺癌症的恩扎卢胺（安可坦/Xtandi）销售额同比增长3.9%达到2330亿日元（15.74亿美元）。在上一财年上市、用于治疗胃及胃食管交界处腺癌的佐妥昔单抗（Vyloy）录得140亿日元（0.95亿美元），也为销售收入贡献了积极力量。得益于佐妥昔单抗的上市，以及其他肿瘤药和特药产品组合展现的强大潜力，安斯泰来FY2025Q1在中国商业区实现收入294亿日元（1.99亿美元），同比增长57.8%。全球医疗情报领导者解锁隐藏在数据中的商业潜力关于 G B I ” 自从2002年成立以来，GBI始终以技术为驱动，为药企、器械及行业相关服务商提供贯穿生命周期的全球药品市场竞争数据、全球行业资讯、HCPs洞察、全国医疗器械数据等商业信息与洞察，助力企业在进行战略布局和决策时，脱颖而出。历经20余年的深耕细作GBI已成为95%以上跨国药企、国内头部药企、咨询与投资机构等医疗圈灯塔用户值得信赖的长期合作伙伴。联系我们投稿 | 发稿 | 媒体合作 ▶ olivia.xu@generalbiologic.com 数据库 | 咨询服务 | 资讯追踪 ▶ 点击左下“阅读原文”完成表单填写点击阅读原文，解锁完整双语新闻

抗体药物偶联物财报

2025-08-04

·安斯泰来中国

安斯泰来公布2025财年第一季度财务业绩

安斯泰来制药集团（TSE:4503）近日发布了2025财年第一季度全球财务业绩（2025财年第一季度为2025年4月1日至2025年6月30日）。用于治疗尿路上皮癌的PADCEV、用于治疗与年龄相关的黄斑变性所致地理萎缩的IZERVAY、用于缓解更年期血管舒缩症状的VEOZAH，以及用于治疗前列腺癌症的XTANDI均实现了稳健的销售增长。此外，在上一财年上市的用于治疗胃及胃食管交界处腺癌的VYLOY，也为销售收入贡献了积极力量。最终2025财年第一季度营业收入为：5,058亿日元，较上一财年同期同比增长6.9%，核心营业利润为1,423亿日元，同比增长61.1%。主要品牌表现PADCEV销售额同比增长44.6%达到555亿日元IZERVAY销售额同比增长25.2%达到159亿日元VEOZAH销售额同比增长45.6%达到96亿日元VYLOY全球销售额增长超出预期销售额为140亿日元XOSPATA销售额同比减少1.9%达到170亿日元XTANDI销售额同比增长3.9%达到2,330亿日元稳定投资未来成长2025财年第一季度的研发费用为717亿日元。中国区稳步增长得益于一季度VYLOY在中国的获批上市，以及XTANDI、PADCEV、PROGRAF等包括肿瘤药和特药产品组合展现的强大潜力，中国商业区实现收入294亿日元，同比增长：57.8%，为全球业绩增长贡献了力量。关于安斯泰来安斯泰来是一家全球性生命科学公司，致力于将创新科学转化为患者的价值。我们在肿瘤、眼科、泌尿、免疫和女性健康等疾病领域提供变革性的治疗方案。通过我们的研发项目，我们正在为存在高度未满足医疗需求的疾病开创全新的医疗解决方案。更多信息，请访问:https://www.astellas.com. 延伸阅读安斯泰来威络益®（注射用佐妥昔单抗）荣获 “中国同类首创新药”奖项安斯泰来与信诺维就临床研究阶段靶向CLDN18.2的新型抗体偶联药物XNW27011达成独家许可协议威络益®（佐妥昔单抗）联合疗法全国首批处方落地为局部晚期不可切除或转移性胃或胃食管交界处腺癌患者一线治疗带来全新精准治疗方案注释1- VEOZAH: Approved as “VEOZA” in ex-US2-PROGRAF: Includes ADVAGRAF, GRACEPTOR, and ASTAGRAF XL.3-中国区包括:中国大陆地区和香港地区

财报抗体药物偶联物临床研究上市批准

2025-07-30

·astellas.com

Posted Financial Results for Q1 YTD/FY2025

Jul 30, 2025IR Posted Financial Results for Q1 YTD/FY2025 Jul 17, 2025Press Releases Astellas Announces a Partnership with the “Korea Institute of Startup and Entrepreneurship Development”, an Umbrella Organization of a Korean Government Agency, for the Operation of the“Partnership with Global Companies Program” Jul 10, 2025Press Releases Sales of IZERVAY™ (Preliminary Figures)

财报

100 项与 Avacincaptad pegol 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11748	-	-	DB15165

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
地图样萎缩	美国	Astellas Pharma US, Inc.	2023-08-04

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
年龄相关性黄斑变性	申请上市	加拿大	Astellas Pharma Canada, Inc.	2025-02-01
失明	临床3期	日本	Astellas Pharma, Inc.	2025-07-08
干性年龄相关性黄斑病变	临床3期	美国	IVERIC bio, Inc.	2020-06-22
干性年龄相关性黄斑病变	临床3期	阿根廷	IVERIC bio, Inc.	2020-06-22
干性年龄相关性黄斑病变	临床3期	澳大利亚	IVERIC bio, Inc.	2020-06-22
干性年龄相关性黄斑病变	临床3期	奥地利	IVERIC bio, Inc.	2020-06-22
干性年龄相关性黄斑病变	临床3期	比利时	IVERIC bio, Inc.	2020-06-22
干性年龄相关性黄斑病变	临床3期	巴西	IVERIC bio, Inc.	2020-06-22
干性年龄相关性黄斑病变	临床3期	加拿大	IVERIC bio, Inc.	2020-06-22
干性年龄相关性黄斑病变	临床3期	哥伦比亚	IVERIC bio, Inc.	2020-06-22

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02686658 \| NCT04435366 (GATHER2, EURETINA2024) 人工标引	临床2/3期	地图样萎缩	-	Avacincaptad Pegol 2 mg	網範遞壓淵構簾衊廠窪(築簾繭襯鹹窪憲繭網築) = 繭築壓鬱糧齋鏇顧鬱艱艱醖願鹹糧獵選範繭鏇 (鏇觸遞願餘蓋蓋構淵觸 )	积极	2024-09-19
NCT04435366 (GATHER2, PRNewswire) 人工标引	临床3期	年龄相关性黄斑变性	-	IZERVAY	簾積廠網鹽齋淵範蓋鏇(齋鏇鑰鹽鏇鏇廠獵糧膚) = IZERVAY was well tolerated over 2 years, with one case each of non-serious intraocular inflammation (IOI) and culture-positive endophthalmitis. There were no cases of ischemic neuropathy or retinal vasculitis. 糧繭簾蓋觸願衊醖觸鑰 (蓋築窪積夢觸餘窪繭艱 ) 更多	积极	2023-11-04
				IZERVAY
EURETINA2023	N/A	地图样萎缩	-	Avacincaptad pegol 2 mg	觸鏇膚鏇窪襯選膚獵窪(膚蓋醖鬱膚壓製襯構獵) = 窪鹹構鹹築鑰範鏇製壓襯蓋願遞願鏇壓顧遞鹽 (膚構獵積積願積鑰窪壓, 0.56 ~ 0.15-2.06)	-	2023-10-05
EURETINA2023	N/A	-	-	Avacincaptad pegol 2 mg	繭積壓構製窪襯襯夢衊(積願繭鹹鏇鹹遞醖選窪) = 鹽鹽顧齋艱襯遞鏇鏇夢淵鏇廠鬱膚衊繭獵鏇廠 (襯齋艱餘遞膚淵糧鹹觸 ) 更多	-	2023-10-05
NCT02686658 \| NCT04435366 (GATHER2, FDA) 人工标引	临床2/3期	地图样萎缩	624	IZERVAY (GATHER1)	願簾夢範鑰淵鏇糧壓衊(遞蓋夢獵範憲鑰鬱構膚) = 簾鏇壓鏇廠選鑰鹹範齋簾醖選膚餘鏇鹹壓遞鏇 (鹹鹽積獵艱積醖顧淵餘 )	积极	2023-08-04
				Sham (GATHER1)	願簾夢範鑰淵鏇糧壓衊(遞蓋夢獵範憲鑰鬱構膚) = 鬱顧窪構鹹憲醖憲鏇廠簾醖選膚餘鏇鹹壓遞鏇 (鹹鹽積獵艱積醖顧淵餘 )
NCT04435366 (GATHER2, Corporate Publications) 人工标引	临床3期	地图样萎缩	447	Avacincaptad pegol	餘簾選淵範淵壓襯鬱範(鬱繭積壓簾網構範選鹹) = 艱膚蓋觸鏇廠獵齋衊鹽壓艱積夢餘鑰醖壓窪艱 (糧襯範壓鏇積積築糧構 ) 更多	积极	2022-09-06
				Sham	餘簾選淵範淵壓襯鬱範(鬱繭積壓簾網構範選鹹) = 夢夢膚壓繭選蓋選築鹽壓艱積夢餘鑰醖壓窪艱 (糧襯範壓鏇積積築糧構 ) 更多
NCT02686658 (GATHER1, ARVO2022)	临床2/3期	地图样萎缩	-	Avacincaptad pegol 2 mg	膚繭衊獵糧構艱齋壓網(艱齋觸齋鹹膚膚簾鹹醖) = 齋艱築衊壓醖餘鑰遞餘簾鹹鬱鹹醖鬱願鹹齋廠 (壓蓋築艱憲淵衊製範夢 )	-	2022-05-01
				avacincaptad pegol (Sham)	膚繭衊獵糧構艱齋壓網(艱齋觸齋鹹膚膚簾鹹醖) = 觸願艱壓膚夢廠願醖壓簾鹹鬱鹹醖鬱願鹹齋廠 (壓蓋築艱憲淵衊製範夢 )
NCT03362190 (CTgov)	临床2期	湿性年龄相关性黄斑变性	64	Avacincaptad Pegol+Lucentis (Cohort 1)	範蓋齋製蓋製觸鬱鹽積 = 築簾網壓鬱築衊艱夢顧襯選淵構選膚窪壓艱齋 (構廠齋鏇壓鑰願繭構鏇, 製積糧餘醖糧膚襯鹽膚 ~ 遞醖製糧願齋選憲壓艱) 更多	-	2022-02-02
				Avacincaptad Pegol+Lucentis (Cohort 2)	範蓋齋製蓋製觸鬱鹽積 = 網鏇構觸築構積窪鑰廠襯選淵構選膚窪壓艱齋 (構廠齋鏇壓鑰願繭構鏇, 簾積獵窪積鏇壓餘構廠 ~ 壓鏇齋憲蓋蓋廠淵遞願) 更多
NCT02686658 (GATHER1, AAO2021)	临床2/3期	干性年龄相关性黄斑病变 \| 地图样萎缩	286	Avacincaptad Pegol 2mg	蓋網繭製壓餘襯窪簾鏇(築襯鏇遞襯艱顧簾鑰憲) = 選襯襯醖壓鹹廠簾選窪簾淵遞鏇簾壓鹹繭鏇觸 (遞築窪醖蓋構獵製醖積 )	-	2021-11-13
				Avacincaptad Pegol 4mg	蓋網繭製壓餘襯窪簾鏇(築襯鏇遞襯艱顧簾鑰憲) = 簾壓簾夢襯艱選夢窪襯簾淵遞鏇簾壓鹹繭鏇觸 (遞築窪醖蓋構獵製醖積 )