Four-Year Outcomes of Faricimab in Diabetic Macular Edema in the RHONE-X Extension Trial: A Podcast.

IF 4.2 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2026-10-01 Epub Date: 2026-08-20 DOI:10.1007/s40123-026-01470-6

Veeral S Sheth, Stela Vujosevic

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引用次数: 0

Abstract

Diabetic macula edema (DME) is a leading cause of vision loss among people with diabetes and requires long-term management strategies that balance efficacy, safety, and durability. Although antivascular endothelial growth factor (VEGF) therapies have improved outcomes, challenges remain in achieving sustained disease control and reducing intravitreal injection frequency. Faricimab is a dual angiopoietin-2/anti-VEGF-A inhibitor designed for intraocular use, which targets the vascular and inflammatory components of DME. The phase 3 YOSEMITE and RHINE clinical trials demonstrated the efficacy, durability, and safety of faricimab throughout 2 years in treatment-naive and previously treated patients with DME. RHONE-X (NCT04432831) was a phase 3, multicenter, nonrandomized, open-label extension trial of the YOSEMITE/RHINE clinical trials that assessed the long-term safety and efficacy of faricimab treat-and-extend (T&E) for an additional 2 years. In this podcast, two retina specialists, Dr. Veeral Sheth (USA) and Dr. Stela Vujosevic (Italy), discuss the outcomes of faricimab after 4 years in DME and the implications on clinical practice. The speakers note that faricimab was well tolerated throughout 2 years of RHONE-X with a safety profile consistent with that observed during 2 years in YOSEMITE/RHINE. Furthermore, vision and anatomical improvements achieved during YOSEMITE/RHINE were maintained through the RHONE-X study, while treatment burden was eased with approximately 80% of patients on a faricimab dosing interval of ≥ every 12 weeks by the end of RHONE-X. Additionally, the proportion of aflibercept-treated patients achieving retinal drying increased after switching to faricimab. The speakers discussed the potential real-world clinical implications of these findings, including improved quality of life for patients and the ability for clinicians to treat more patients due to the reduced treatment burden, while maintaining safety and efficacy. In conclusion, findings from RHONE-X demonstrated the long-term safety, efficacy, and durability of faricimab T&E in DME, all relevant for real-world practice.Trial Registration: ClinicalTrials.gov identifier: NCT04432831. Supplementary material 1 (MP4 1,48,502 kb).

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rone - x扩展试验中Faricimab治疗糖尿病黄斑水肿的四年结果：播客

糖尿病性黄斑水肿（DME）是糖尿病患者视力丧失的主要原因，需要平衡疗效、安全性和持久性的长期管理策略。尽管抗血管内皮生长因子（VEGF）治疗改善了结果，但在实现持续的疾病控制和减少玻璃体内注射频率方面仍然存在挑战。Faricimab是一种双重血管生成素-2/抗vegf - a抑制剂，设计用于眼内使用，靶向DME的血管和炎症成分。YOSEMITE和RHINE的3期临床试验在2年的时间里证明了faricimab在未接受治疗和之前接受过治疗的二甲醚患者中的有效性、持久性和安全性。RHONE-X （NCT04432831）是YOSEMITE/RHINE临床试验的3期、多中心、非随机、开放标签扩展试验，评估法利昔单抗治疗和延长（T&E）的长期安全性和有效性，延长2年。在本播客中，两位视网膜专家Veeral Sheth博士（美国）和Stela Vujosevic博士（意大利）讨论了faricimab在DME治疗4年后的结果及其对临床实践的影响。发言者指出，faricimab在2年的RHONE-X治疗中耐受性良好，其安全性与在YOSEMITE/RHINE治疗中观察到的2年的安全性一致。此外，通过RHONE-X研究，YOSEMITE/RHINE期间获得的视力和解剖改善得以维持，同时治疗负担减轻，约80%的患者在RHONE-X研究结束时每12周服用一次法昔单抗。此外，改用法利西单抗治疗后，阿利西单抗治疗患者视网膜干燥的比例增加。演讲者讨论了这些发现潜在的现实世界临床意义，包括改善患者的生活质量和临床医生治疗更多患者的能力，因为减少了治疗负担，同时保持了安全性和有效性。总之，rone - x的研究结果证明了faricimab T&E治疗DME的长期安全性、有效性和持久性，这些都与现实世界的实践有关。试验注册：ClinicalTrials.gov标识符：NCT04432831。

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of ophthalmic therapies. Open Access All articles published by Ophthalmology and Therapy are open access. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. Digital Features and Plain Language Summaries Ophthalmology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. For examples of digital features please visit our showcase page https://springerhealthcare.com/expertise/publishing-digital-features/ Publication Fees Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of €5250/$6000/£4300. The journal will consider fee discounts and waivers for developing countries and this is decided on a case by case basis. Peer Review Process Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials, and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case-by-case basis and should be sent to the journal editor. 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Please follow the link for further information on preprint sharing: https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550 Copyright Ophthalmology and Therapy''s content is published open access under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0. Contact For more information about the journal, including pre-submission enquiries, please contact christopher.vautrinot@springer.com.