An Open-label Extension (OLE) Phase 3 Trial to Assess the Safety of Intravitreal Administration of Avacincaptad Pegol (Complement C5 Inhibitor) in Patients With Geographic Atrophy Who Previously Completed Phase 3 Study ISEE2008 (GATHER2)

The purpose of this study is to assess long-term safety of avacincaptad pegol intravitreal administration for patients with geographic atrophy (GA) who completed Study ISEE2008 (GATHER2) through the Month 24 visit on study treatment (either avacincaptad pegol or Sham).

开始日期2022-09-26

申办/合作机构

Astellas Pharma Global Development, Inc.

NCT04435366 / Completed临床3期

A Phase 3 Multicenter, Randomized, Double Masked, Sham- Controlled Clinical Trial to Assess the Safety and Efficacy of Intravitreal Administration of Zimura (Complement C5 Inhibitor) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

The objectives of this study are to evaluate the safety and efficacy of Zimura (avacincaptad pegol) intravitreal administration in patients with geographic atrophy secondary to age-related macular degeneration (AMD)

开始日期2020-06-22

申办/合作机构

IVERIC bio, Inc.

NCT03374670 / Withdrawn临床2期

A Phase 2A Open-Label Trial to Assess the Safety of ZIMURA™ (Anti-C5) in Combination With EYLEA® in Treatment Experienced Subjects With Idiopathic Polypoidal Choroidal Vasculopathy

To asses the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Eylea® in treatment experienced subjects with idiopathic polypoidal choroidal vasculopathy

开始日期2018-11-01

申办/合作机构

Ophthotech Corp. (New Jersey)

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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193

项与 Avacincaptad pegol 相关的文献（医药）

2024-03-01·Progress in Retinal and Eye Research

Investing in vision: Innovation in retinal therapeutics and the influence on venture capital investment

Review

作者: Luneborg, Nanna ; Lohoff, Tim ; Mulder, Geert-Jan ; Hristodorov, Dmitrij ; Clark, Simon J

Since the groundbreaking approval of the first anti-VEGF therapy in 2004, the retinal therapeutics field has undergone a remarkable transformation, witnessing a surge in novel, disease-modifying therapeutics for a broad spectrum of retinal diseases, extending beyond exudative VEGF-driven conditions. The surge in scientific advancement and the pressing, unmet, medical need have captured the attention of venture capital investors, who have collectively invested close to $10 billion in research and development of new retinal therapeutics between 2004 and 2023. Notably, the field of exudative diseases has gradually shifted away from trying to outcompete anti-VEGF therapeutics towards lowering the overall treatment burden by reducing injection frequency. Simultaneously, a new era has emerged in the non-exudative field, targeting prevalent conditions like dry AMD and rare indications such as Retinitis pigmentosa. This has led to promising drug candidates in development, culminating in the landmark approval of Luxturna for a rare form of Retinitis pigmentosa. The validation of new mechanisms, such as the complement pathway in dry AMD has paved the way for the approvals of Syvovre (Apellis) and Izervay (Iveric/Astellas), marking the first two therapies for this condition. In this comprehensive review, we share our view on the cumulative lessons from the past two decades in developing retinal therapeutics, covering both positive achievements and challenges. We also contextualize the investments, strategic partnering deals, and acquisitions of biotech companies, pharmaceutical companies venture capital investors in retinal therapeutics, respectively. Finally, we provide an outlook and potentially a forward-looking roadmap on novel retinal therapeutics, highlighting the emergence of potential new intervention strategies, such as cell-based therapies, gene editing, and combination therapies. We conclude that upcoming developments have the potential to further stimulate venture capital investments, which ultimately could facilitate the development and delivery of new therapies to patients in need.

2024-01-01·Lancet (London, England)1区 · 医学

Complement in human disease: approved and up-and-coming therapeutics

1区 · 医学

Review

作者: Woodruff, Trent ; Kemper, Claudia ; West, Erin E ; Fremeaux-Bacchi, Veronique

The complement system is recognised as a protector against blood-borne pathogens and a controller of immune system and tissue homoeostasis. However, dysregulated complement activity is associated with unwanted or non-resolving immune responses and inflammation, which induce or exacerbate the pathogenesis of a broad range of inflammatory and autoimmune diseases. Although the merit of targeting complement clinically has long been acknowledged, the overall complement drug approval rate has been modest. However, the success of the humanised anti-C5 antibody eculizumab in effectively treating paroxysmal nocturnal haemoglobinuria and atypical haemolytic syndrome has revitalised efforts to target complement therapeutically. Increased understanding of complement biology has led to the identification of novel targets for drug development that, in combination with advances in drug discovery and development technologies, has resulted in a surge of interest in bringing new complement therapeutics into clinical use. The rising number of approved drugs still almost exclusively target rare diseases, but the substantial pipeline of up-and-coming treatment options will possibly provide opportunities to also expand the clinical targeting of complement to common diseases.

2023-12-01·Acta Ophthalmologica

Genetic and molecular biomarkers for geographic atrophy

Review

作者: Huh, Hannah ; Shen, Jie ; den Hollander, Anneke I ; Riley-Gillis, Bridget

Abstract:

Geographic atrophy (GA) is characterized by atrophy of the retina, retinal pigment epithelium and choriocapillaris, causing a gradual loss of vision over time. Treatment options to prevent initiation or progression of GA are limited; two recently FDA‐approved inhibitors of the complement system (pegcetacoplan, avacincaptad pegol) showed a modest decrease in GA lesion growth in phase 3 clinical trials. Exploration of genetic and molecular biomarkers in GA plays a critical role in our battle against this blinding disease to improve early disease detection, to find more effective therapies, and to provide personalized care to patients. In this review, we provide a comprehensive overview of the current literature investigating genetic and molecular biomarkers for GA. Genetic studies identified multiple genes and variants that play a role in progression to GA and GA lesion growth, involving pathways such as complement activation, extracellular matrix interaction and lipid metabolism. The number of published studies assessing molecular biomarkers for GA initiation and progression in ocular matrices is limited. Several studies evaluated molecular biomarkers in the systemic circulation, showing higher levels of complement activation and a causal role of lipid subfractions in GA. Larger, well‐powered studies are needed to identify novel and validate existing biomarkers, and to investigate the potential of combining genetic and molecular markers with imaging techniques for more accurate diagnosis and monitoring of GA. The development of personalized medicine approaches based on individual genetic and molecular profiles could hold promise for more effective and targeted treatments for this devastating disease.

157

项与 Avacincaptad pegol 相关的新闻（医药）

2024-05-01

·BioSpace

Apellis Announces 11 Oral Presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting

WALTHAM, Mass., May 01, 2024 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that 14 abstracts, 11 of which are oral presentations, will be presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting to be held May 5 - 9 in Seattle. The data continue to reinforce the robust efficacy and safety pro SYFOVRE® (pegcetacoplan injection) for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). “The 11 oral presentations at ARVO speak to the continued excitement surrounding SYFOVRE, which is the most chosen GA treatment by retina specialists,” said Caroline Baumal, M.D., chief medical officer, Apellis. “We are excited to share data that continue to highlight SYFOVRE’s ability to slow disease progression with increasing effects over time and its potential to preserve visual function longer.” Oral presentations: Long-term efficacy and safety of pegcetacoplan over 36 months: results from 12 months of the GALE open-label extension study – Ashkan Abbey, M.D. – Sunday, May 5 – 1:45‑2:00 PM PDT (encore) Pegcetacoplan vs avacincaptad pegol in geographic atrophy: an anchored matching-adjusted indirect comparison of three phase 3 trials – Marco Zarbin, M.D., Ph.D. – Thursday, May 9 – 2:15‑2:30 PM PDT (encore) Pegcetacoplan delays time to loss of central macular sensitivity: a microperimetry analysis of the phase 3 OAKS study – Rishi Singh, M.D., FASRS – Thursday, May 9 – 3:30‑3:45 PM PDT (encore) The SD-OCT correlates of fundus autofluorescence in geographic atrophy: a comprehensive point-to-point analysis of fundus autofluorescence with SD-OCT using phase 3 trials DERBY and OAKS – Konstantinos Balaskas, M.D. – Sunday, May 5 – 2:15‑2:30 PM PDT Variability of perilesional FAF patterns associated with automated OCT-based PR/RPE loss ratios in GA progression in the phase 3 OAKS/DERBY trials – Julia Mai, M.D. – Sunday, May 5 – 4:45‑5:00 PM PDT Contrast sensitivity function using a prototype gaze tracking-based virtual reality headset in age-related macular degeneration (AMD) – Deepayan Kar, Ph.D., MS – Monday, May 6 – 8:30‑8:45 AM PDT A deep-learning approach to identifying quantitative OCT biomarkers predictive of visual deficit measured by microperimetry at 24 months in OAKS trial – Dun Jack Fu, Ph.D., BMBCh – Tuesday, May 7 – 9:30‑9:45 AM PDT AI-based qOCT analysis of phase 3 trials OAKS & DERBY data on the effect of pegcetacoplan on geographic atrophy – Pallavi Bagga, Ph.D. – Tuesday, May 7 – 2:15‑2:30 PM PDT Predictive value of the photoreceptor/RPE loss ratio on OCT in the management of geographic atrophy (GA) for patient selection and monitoring of therapeutic efficacy – Ursula Schmidt‑Erfurth, M.D. – Tuesday, May 7 – 2:30‑2:45 PM PDT Rate of response to treatment in eyes with geographic atrophy treated with Pegcetacoplan in a within-patient comparison using automated AI-based OCT biomarker quantifications in OAKS, DERBY and GALE – Gregor S. Reiter, M.D., Ph.D. – Thursday, May 9 – 2:30‑2:45 PM PDT IRIS® Registry analysis of anti-VEGF treatment in patients with coexisting neovascular age-related macular degeneration and geographic atrophy – Theodore Leng, M.D., FACS – Thursday, May 9 – 3:15‑3:30 PM PDT Poster presentations: Prevalence of outer retinal tubulation (ORT) and association with geographic atrophy (GA) growth among patients in the OAKS and DERBY trials – Kensington Hatcher, O.D., FAAO – Monday, May 6 – 3:00‑4:45 PM PDT Loss of independence in geographic atrophy (GA) - results from the MOSAIC study among patients and caregivers in Europe – Beverly Lui, PharmD – Thursday, May 9 – 8:00‑9:45 AM PDT Deep learning-based segmentation of geographic atrophy in fundus autofluorescence: external validation in imaging acquired in a clinical trial – Souvick Mukherjee, Ph.D. – Thursday, May 9 – 8:00‑9:45 AM PDT About SYFOVRE® (pegcetacoplan injection) SYFOVRE® (pegcetacoplan injection) is the first-ever approved therapy for geographic atrophy (GA). By targeting C3, SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system. SYFOVRE is approved in the United States for the treatment of GA secondary to age-related macular degeneration. About Geographic Atrophy (GA) Geographic atrophy (GA) is an advanced form of age-related macular degeneration and a leading cause of blindness worldwide, impacting more than one million Americans and five million people worldwide.1,2 It is a progressive and irreversible disease caused by the growth of lesions, which destroy the retinal cells responsible for vision. The vision loss caused by GA severely impairs independence and quality of life by making it difficult to participate in daily activities. On average, it takes only 2.5 years for GA lesions to start impacting the fovea, which is responsible for central vision.3 U.S. Important Safety Information for SYFOVRE® (pegcetacoplan injection) CONTRAINDICATIONS SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation WARNINGS AND PRECAUTIONS Endophthalmitis and Retinal Detachments Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments. Proper aseptic injection technique must always be used when administering SYFOVRE to minimize the risk of endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. Retinal Vasculitis and/or Retinal Vascular Occlusion Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE. Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay. Neovascular AMD In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration. Intraocular Inflammation In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves, patients may resume treatment with SYFOVRE. Increased Intraocular Pressure Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed. ADVERSE REACTIONS Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, conjunctival hemorrhage. Please see accompanying full Prescribing Information for more information. About Apellis Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. We believe we have only begun to unlock the potential of targeting C3 across serious retinal, rare, and neurological diseases. For more information, please visit or follow us on Twitter and LinkedIn. Apellis Forward-Looking Statement Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the Securities and Exchange Commission on February 27, 2024 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Media Contact: Lissa Pavluk media@apellis.com 617.977.6764 Investor Contact: Meredith Kaya meredith.kaya@apellis.com 617.599.8178 1Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571–580. 2Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116. 3Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.

临床3期上市批准

2024-04-29

·BioSpace

Inflammasome Therapeutics Announces First Patient Dosed in Geographic Atrophy (GA) Clinical Trial

Phase 1 investigator-sponsored clinical trial “Evaluation of Kamuvudine-8 in Subjects with Geographic Atrophy (K8 for GA)” for a blinding condition resulting from dry age-related macular degeneration (dry AMD). Open label 26-week study designed to evaluate the safety and treatment efficacy of K8, a novel neuroprotectant that will target the underlying cause of vision loss in GA. Expected to treat up to five subjects with intravitreous injection of intraocular implant designed to last for three months. Marks second clinical trial underway for Inflammasome Therapeutics that uses the company’s proprietary new class of drugs. Trial for DME also recruiting (ClinicalTrials.gov ID NCT05699759). Kamuvudines are shown in pre-clinical research to inhibit the underlying cause of vision loss in GA. NEWTON, Mass.--(BUSINESS WIRE)-- Inflammasome Therapeutics ( ), a private company developing a new class of inflammasome inhibitor drugs, Kamuvudines, as therapies for prevalent, degenerative diseases, announced the first patient has been dosed in a first-in-class clinical trial for dry AMD. The Phase 1 trial (ClinicalTrials.gov ID NCT06164587) is sponsored by the University of Kentucky and expected to enroll up to five patients with GA due to age-related macular degeneration (AMD). This press release features multimedia. View the full release here: Inflammasome's K8, a tiny sustained release implant that provides slow, consistent release of the drug K8 (inflammasome inhibitor drug Kamuvudine) directly in the back of the eye for a period of three months. (Photo: Business Wire) Trial participants will receive a tiny, sustained release implant (illustration is available) that will provide slow, consistent release of the drug K8 directly into the back of the eye. K8 was specifically designed for retinal delivery and the implants and injector system were crafted to deliver this particular drug. This combined drug and delivery strategy allows high therapeutic doses to be maintained in the eye while the drug is undetectable in systemic circulation. “This marks the second trial underway with our Kamuvudines in ophthalmology,” said Dr. Paul Ashton, President and CEO of Inflammasome Therapeutics, developers of both the compounds and delivery systems for administration. GA affects approximately one million individuals in the US and more than eight million worldwide. In GA, multiple toxic substances (such as complement, amyloid beta, retrotransposons, iron, and reactive oxygen species) build up in the eye and trigger inflammasome activation that then causes cells in the macula to slowly die (atrophy). This is a very similar process to what goes on in the brain and nervous system in patients with ALS, Alzheimer’s disease and multiple sclerosis. Last year, two drugs (Syfovre and Izervay) were approved for GA that target one of these toxic substances, complement. The drugs do not target other toxic elements and only modestly slow progression of the disease. Unfortunately, they also increase the risk of developing wet AMD. Furthermore, the drugs require an intraocular injection every four to eight weeks. There is tremendous interest in developing potential GA treatments. There are 38 other interventional clinical trials for GA registered in clinicaltrials.gov., almost all of which target individual toxic substances, but not the underlying cause of the atrophy, inflammasome activation. “That’s where we believe we provide a distinctive and significant difference,” said Dr. Ashton. “Our Kamuvudines have been shown in pre-clinical studies to block inflammasome activation caused by multiple toxic pathways – complement, amyloid beta, iron overload, retrotransposons, etc. If we can block inflammasome activation in the clinic, we believe we can have a profound effect on the disease by blocking multiple pathways.” Dr. Ashton confirmed that the implications for treatments in other neuroinflammatory diseases like Alzheimer’s Disease, ALS and Multiple Sclerosis are “extremely interesting. We have Kamuvudines specifically designed for neurological diseases that penetrate into the brain and Central Nervous System from a simple oral tablet. Inflammasome Therapeutics is expected to begin clinical trials in some of these diseases soon as well,” he affirmed. Inflammasome Therapeutics’ co-founder, Dr. Jayakrishna Ambati, has spent more than a decade developing Kamuvudines and identifying their role in the inhibition of inflammasome activity that is being found to be the underlying cause of many diseases. In a series of publications in journals such as Science and Nature, he has described the basic research on GA and pre-clinical development of Kamuvudines: Dr. Ambati and Dr. Ashton co-founded Inflammasome Therapeutics in 2016 to develop therapies for prevalent, degenerative diseases and to develop novel delivery technologies for the sustained release of therapeutic agents and compounds. The company combines scientific excellence with proven development expertise and works to develop products via a mixture of licensing agreements and internal development, including work with Boehringer Ingelheim and the Gates Foundation.

临床1期上市批准

2024-04-27

·医药笔记

补体赛道：2款潜在重磅炸弹冉冉升起

▎Armstrong2024年4月25日，安斯泰来发布2023年财报（日本财年为4月1日至次年3月31日）。2024年一季度，恩杂鲁胺销售额12.05亿美元，Nectin-4 ADC销售额1.88亿美元（另有辉瑞部分未计入），C5靶向Aptamer销售额0.44亿美元。2023年8月5日，Iveric Bio宣布FDA批准Avacincaptad pegol上市，用于治疗地图样萎缩（GA），商品名为Izervay。此前的5月，安斯泰来以59亿美元收购Iveric Bio，获得Izervay。Izervay为一款靶向补体C5的aptamer。Avacincaptad Pegol在两项三期临床中证实可以显著改善地图样萎缩（GA）的疾病进展。安斯泰来预计Izervay 2024年的销售额将达到464亿日元，约合2.93亿美元。Apellis靶向补体C3的环肽药物更早获批治疗GA，商品名为Syfovre，2023年因为视网膜血管炎副作用问题，销售一度受阻，到四季度已经恢复增长态势，四季度销售额1.14亿美元，2023年全年销售额2.75亿美元。总结阿斯利康两款补体C5抗体年销售额超过60亿美元，后来者Apellis、Iveric通过GA这一常见病适应症实现破局，有望成为补体领域的两款重磅炸弹药物。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

财报抗体药物偶联物临床3期并购医药出海

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

适应症	最高研发状态	国家/地区	公司
地图样萎缩	批准上市	美国更多	Astellas Pharma US, Inc. 更多
年龄相关性黄斑变性	临床3期	加拿大更多	IVERIC bio, Inc. 更多
黄斑变性	临床3期	-	Archemix Corp. 更多
斯塔加特病	临床2期	-	IVERIC bio, Inc. 更多
干性年龄相关性黄斑病变	无进展	克罗地亚更多	IVERIC bio, Inc. 更多

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临床结果

适应症

分期

评价

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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


NCT04435366 (CTgov)	临床3期	年龄相关性黄斑变性 \| 地图样萎缩	448	Avacincaptad Pegol (Avacincaptad Pegol Treatment Group)	齋繭鹹窪廠窪窪鬱願蓋(鹹膚窪鏇鏇鏇願構淵淵) = 製築艱鏇鬱蓋繭醖醖夢築獵築範壓衊衊襯繭艱 (選糧築積艱構製夢顧鏇, 餘醖繭選襯餘構獵衊選 ~ 齋憲鬱廠齋繭膚淵餘遞) 更多	-	2023-12-28
				Sham (Sham Treatment Group)	齋繭鹹窪廠窪窪鬱願蓋(鹹膚窪鏇鏇鏇願構淵淵) = 築淵願獵選鹽積範觸夢築獵築範壓衊衊襯繭艱 (選糧築積艱構製夢顧鏇, 餘夢鬱構積餘糧範鬱醖 ~ 糧餘鹽築憲顧膚鏇簾製) 更多
GATHER2 (PRNewswire) 人工标引	临床3期	年龄相关性黄斑变性	-	IZERVAY	積醖淵鹽鏇糧積鏇襯餘(鬱廠繭範鬱餘鑰範鏇窪) = 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. 鑰蓋廠糧遞襯顧憲膚淵 (膚選衊餘構醖艱鏇襯壓 ) 更多	积极	2023-11-04
				IZERVAY
NCT02686658 \| NCT04435366 (GATHER1 \| GATHER2, FDA) 人工标引	临床2/3期	地图样萎缩	624	IZERVAY (GATHER1)	糧鹽範鏇鏇鏇製網衊襯(遞餘壓選繭夢糧觸選觸) = 夢築齋壓願簾夢餘鑰鏇繭觸繭艱襯艱齋範艱夢 (齋衊艱餘獵餘簾顧糧壓 )	积极	2023-08-04
				Sham (GATHER1)	糧鹽範鏇鏇鏇製網衊襯(遞餘壓選繭夢糧觸選觸) = 壓遞鹽願鑰願鏇襯壓糧繭觸繭艱襯艱齋範艱夢 (齋衊艱餘獵餘簾顧糧壓 )
NCT05571267 (CTgov)	临床2期	年龄相关性黄斑变性	1	Zimura+avastin (Zimura and Avastin)	鬱鬱鏇衊築簾遞憲壓積(簾窪夢遞糧願積鹽鏇餘) = 積鏇選積艱築廠遞鹽積襯築顧壓糧觸製構膚鑰 (艱窪網鑰壓鏇築襯構艱, 願鏇獵積願鹽鹽積廠齋 ~ 積膚夢醖構餘獵顧糧顧) 更多	-	2023-04-03
				Zimura+Lucentis (Zimura and Lucentis)	觸鏇積齋醖壓鬱願醖鹽(製艱觸膚蓋鑰蓋壓餘網) = 觸繭鹽鹽鹽餘繭鏇積憲鑰衊簾網齋鹹齋醖繭壓 (簾夢糧鏇糧憲廠簾鬱壓, 鹽壓鹽夢鑰鹽艱艱廠夢 ~ 範顧範鬱鏇繭範鹹鹹鹽) 更多
NCT04435366 (GATHER2, Corporate Publications) 人工标引	临床3期	地图样萎缩	447	Avacincaptad pegol	鹽艱壓醖醖鑰獵膚製淵(範願積選鑰廠獵繭遞鏇) = 蓋積窪壓顧衊願醖鏇積願窪齋鹹淵糧蓋窪壓遞 (鬱醖製網網艱鑰壓築艱 ) 更多	积极	2022-09-06
				Sham	鹽艱壓醖醖鑰獵膚製淵(範願積選鑰廠獵繭遞鏇) = 鏇製範廠網選蓋窪膚鑰願窪齋鹹淵糧蓋窪壓遞 (鬱醖製網網艱鑰壓築艱 ) 更多
GATHER1 (ARVO2022)	临床2/3期	地图样萎缩	-	Avacincaptad pegol 2 mg	鏇艱鹹糧鹹醖艱製憲壓(簾顧衊夢獵鏇糧築艱鹽) = 鬱憲壓鏇蓋糧膚鹹糧積遞膚壓鹹鏇齋醖醖餘獵 (壓憲範築繭鏇顧築夢製 )	-	2022-05-01
				avacincaptad pegol	鏇艱鹹糧鹹醖艱製憲壓(簾顧衊夢獵鏇糧築艱鹽) = 簾範築繭壓艱醖窪鏇遞遞膚壓鹹鏇齋醖醖餘獵 (壓憲範築繭鏇顧築夢製 )
NCT03362190 (CTgov)	临床2期	湿性年龄相关性黄斑变性	64	Zimura+Lucentis (Cohort 1)	壓簾選鏇獵壓築廠糧網(鹹窪艱衊艱艱廠壓夢鹹) = 夢鹹齋齋網蓋鑰艱艱鹹糧願糧蓋鹹鏇遞顧憲鑰 (築築觸淵蓋積繭憲膚製, 憲遞夢襯淵範顧壓鬱製 ~ 築餘鑰積製襯窪夢鹹製) 更多	-	2022-02-02
				Zimura+Lucentis (Cohort 2)	壓簾選鏇獵壓築廠糧網(鹹窪艱衊艱艱廠壓夢鹹) = 鏇窪遞窪夢衊夢糧選構糧願糧蓋鹹鏇遞顧憲鑰 (築築觸淵蓋積繭憲膚製, 構餘鬱糧製簾獵壓夢鑰 ~ 壓選鬱鑰壓餘製積鹽選) 更多
GATHER1 (AAO2021)	N/A	-	286	Avacincaptad Pegol 2mg	鹽壓窪顧選蓋鬱鹽範壓(鬱顧遞鹽窪願窪觸夢構) = 窪蓋遞鏇窪廠繭淵築餘願糧獵構蓋齋簾製襯鹹 (艱製餘願製憲獵窪壓顧 )	-	2021-11-13
				Avacincaptad Pegol 4mg	鹽壓窪顧選蓋鬱鹽範壓(鬱顧遞鹽窪願窪觸夢構) = 壓簾餘鏇鏇襯夢醖構築願糧獵構蓋齋簾製襯鹹 (艱製餘願製憲獵窪壓顧 )
ARVO2021	N/A	地图样萎缩	-	Avacincaptad pegol 2 mg	願網鹽簾餘範醖糧簾壓(鑰獵鑰餘鑰選餘廠積獵) = There were no significant differences in best-corrected visual acuity or low-luminance visual acuity between avacincaptad and sham-treated patients 壓遞憲構簾網願鑰顧夢 (醖積鹹鏇鬱齋廠鹹鏇艱 ) 更多	积极	2021-06-01
				Avacincaptad pegol 4 mg
NCT02686658 (GATHER1, Pubmed \| Ophthalmology)	临床2/3期	年龄相关性黄斑变性	286	Avacincaptad pegol 2 mg	窪鬱艱鬱膚襯製構鑰衊(襯範憲獵憲憲鏇鏇鹹餘) = There were no avacincaptad pegol-related adverse events (AEs) or inflammation 艱醖蓋衊遞壓壓願蓋淵 (艱餘窪網網壓艱願選糧 ) 更多	-	2020-09-01
				Avacincaptad pegol 4 mg