{"title":"临床试验和现实世界研究检查法利昔单抗和大剂量阿非利西普湿性年龄相关性黄斑变性和糖尿病性黄斑水肿。","authors":"Meghana Kalavar, Jayanth Sridhar","doi":"10.1097/ICU.0000000000001129","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose of review: </strong>The goal of this review is to summarize emerging clinical trial and real world evidence for faricimab and high dose aflibercept (8 mg), two recently approved treatments for wet age-related macular degeneration and diabetic macular edema.</p><p><strong>Recent findings: </strong>Faricimab, a bispecific monoclonal antibody targeting vascular endothelial growth factor (VEGF) and angiopoietin-2, and high-dose aflibercept have demonstrated significant potential for extending treatment intervals while maintaining efficacy. Pivotal clinical trials such as YOSEMITE, and RHINE established faricimab to be noninferior to standard anti-VEGF therapy with superior durability. Real-world data corroborated these results, demonstrating improved anatomic outcomes with extended treatment intervals, though improvements in best corrected visual acuity (BCVA) remains varied. High-dose aflibercept has similarly demonstrated noninferiority in landmark clinical trials such as PHOTON and PULSAR, with extended dosing intervals. However, comprehensive real-world data for high dose aflibercept remains limited and warrants further investigation.</p><p><strong>Summary: </strong>Both faricimab and high-dose aflibercept show promise in reducing treatment burden for wet age-related macular degeneration and diabetic macular edema through extended dosing intervals while maintaining or improving clinical outcomes compared to standard anti-VEGF therapy. Faricimab has demonstrated this both in clinical trials as well as real-world studies, while high-dose aflibercept has demonstrated similar durability in trials but requires additional real-world evidence.</p>","PeriodicalId":50604,"journal":{"name":"Current Opinion in Ophthalmology","volume":" ","pages":"189-198"},"PeriodicalIF":2.6000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Clinical trials and real-world studies examining faricimab and high-dose aflibercept for wet age-related macular degeneration and diabetic macular edema.\",\"authors\":\"Meghana Kalavar, Jayanth Sridhar\",\"doi\":\"10.1097/ICU.0000000000001129\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose of review: </strong>The goal of this review is to summarize emerging clinical trial and real world evidence for faricimab and high dose aflibercept (8 mg), two recently approved treatments for wet age-related macular degeneration and diabetic macular edema.</p><p><strong>Recent findings: </strong>Faricimab, a bispecific monoclonal antibody targeting vascular endothelial growth factor (VEGF) and angiopoietin-2, and high-dose aflibercept have demonstrated significant potential for extending treatment intervals while maintaining efficacy. Pivotal clinical trials such as YOSEMITE, and RHINE established faricimab to be noninferior to standard anti-VEGF therapy with superior durability. Real-world data corroborated these results, demonstrating improved anatomic outcomes with extended treatment intervals, though improvements in best corrected visual acuity (BCVA) remains varied. High-dose aflibercept has similarly demonstrated noninferiority in landmark clinical trials such as PHOTON and PULSAR, with extended dosing intervals. However, comprehensive real-world data for high dose aflibercept remains limited and warrants further investigation.</p><p><strong>Summary: </strong>Both faricimab and high-dose aflibercept show promise in reducing treatment burden for wet age-related macular degeneration and diabetic macular edema through extended dosing intervals while maintaining or improving clinical outcomes compared to standard anti-VEGF therapy. Faricimab has demonstrated this both in clinical trials as well as real-world studies, while high-dose aflibercept has demonstrated similar durability in trials but requires additional real-world evidence.</p>\",\"PeriodicalId\":50604,\"journal\":{\"name\":\"Current Opinion in Ophthalmology\",\"volume\":\" \",\"pages\":\"189-198\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2025-05-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current Opinion in Ophthalmology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/ICU.0000000000001129\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/2/12 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Opinion in Ophthalmology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/ICU.0000000000001129","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/12 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
Clinical trials and real-world studies examining faricimab and high-dose aflibercept for wet age-related macular degeneration and diabetic macular edema.
Purpose of review: The goal of this review is to summarize emerging clinical trial and real world evidence for faricimab and high dose aflibercept (8 mg), two recently approved treatments for wet age-related macular degeneration and diabetic macular edema.
Recent findings: Faricimab, a bispecific monoclonal antibody targeting vascular endothelial growth factor (VEGF) and angiopoietin-2, and high-dose aflibercept have demonstrated significant potential for extending treatment intervals while maintaining efficacy. Pivotal clinical trials such as YOSEMITE, and RHINE established faricimab to be noninferior to standard anti-VEGF therapy with superior durability. Real-world data corroborated these results, demonstrating improved anatomic outcomes with extended treatment intervals, though improvements in best corrected visual acuity (BCVA) remains varied. High-dose aflibercept has similarly demonstrated noninferiority in landmark clinical trials such as PHOTON and PULSAR, with extended dosing intervals. However, comprehensive real-world data for high dose aflibercept remains limited and warrants further investigation.
Summary: Both faricimab and high-dose aflibercept show promise in reducing treatment burden for wet age-related macular degeneration and diabetic macular edema through extended dosing intervals while maintaining or improving clinical outcomes compared to standard anti-VEGF therapy. Faricimab has demonstrated this both in clinical trials as well as real-world studies, while high-dose aflibercept has demonstrated similar durability in trials but requires additional real-world evidence.
期刊介绍:
Current Opinion in Ophthalmology is an indispensable resource featuring key up-to-date and important advances in the field from around the world. With renowned guest editors for each section, every bimonthly issue of Current Opinion in Ophthalmology delivers a fresh insight into topics such as glaucoma, refractive surgery and corneal and external disorders. With ten sections in total, the journal provides a convenient and thorough review of the field and will be of interest to researchers, clinicians and other healthcare professionals alike.