罗氏公布Vabysmo在亚洲PCV患者SALWEEN研究两年数据

The SALWEEN study showed significant improvements in vision and retinal health
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More than 60% of Asian patients with polypoidal choroidal vasculopathy (PCV), an aggressive subtype of nAMD, treated with Vabysmo showed no signs of polypoidal lesions
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By the end of year two, more than 60% of patients were on an extended 20-week treatment interval, reducing treatment burden
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Vabysmo was well tolerated with a consistent long-term safety profile
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Basel, 28 August 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new two-year data from the Phase IIIb/IV SALWEEN study of Vabysmo
®
(faricimab), presented at the 19
th
Asia-Pacific Vitreo-retina Society (APVRS) Congress in Australia.
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The results showed significant improvements in vision and retinal health in patients with polypoidal choroidal vasculopathy (PCV), a severe sub-type of neovascular age-related macular degeneration (nAMD), the leading cause of vision loss in people over the age of 60.
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“The two-year SALWEEN results demonstrate the sustained efficacy and durability of Vabysmo in people living with PCV, a difficult-to-treat subtype of nAMD that is common in Asia,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Since its initial approval, Vabysmo continues to demonstrate strong efficacy, durability and a favourable safety profile in treating a range of high-burden eye diseases.”
"PCV is an aggressive subtype of nAMD that accounts for up to 60% of cases in Asian populations — a burden that will only grow as the population ages,” said Professor Gemmy Cheung, MBBS, FRCOphth, MD, PhD, Duke-NUS Medical School, National University of Singapore. “These two-year results show that dual Ang-2/VEGF-A inhibition can change the trajectory of this vision-threatening disease. Achieving polypoidal lesion inactivation in nearly nine out of 10 patients, while allowing most to maintain a 20-week dosing interval, means Vabysmo can provide disease control while also drastically reducing the treatment burden."
The study showed that patients experienced a gain of 7.3 letters in best-corrected visual acuity (BCVA) and a reduction of 127 µm in central subfield thickness (CST) from baseline averaged over weeks 100–108. At year two, 74% of patients had no retinal fluid. Vabysmo also had a clinically meaningful impact on the abnormal, polyp-like blood vessels characteristic of PCV, with complete regression (62%) and inactivation (86%) of polypoidal lesions in the majority of eyes. At the end of the first year, 51% of patients were assigned to extended 20-week dosing, which increased to 61% by the end of year two. Vabysmo was well tolerated, with a safety profile in PCV that was consistent with its known safety profile in nAMD.
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About neovascular age-related macular degeneration
Age-related macular degeneration (AMD) is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. nAMD is an advanced form of the disease that can cause rapid and severe vision loss if left untreated.
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It develops when new and abnormal blood vessels grow uncontrolled under the macula, causing swelling, bleeding and/or fibrosis.
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Worldwide, around 20 million people are living with nAMD – the leading cause of vision loss in people over the age of 60 – and the condition will affect even more people around the world as the global population ages.
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About polypoidal choroidal vasculopathy
Polypoidal choroidal vasculopathy (PCV) is a subtype of nAMD that is more prevalent in people of Asian descent, accounting for up to 60% of nAMD cases in this population and up to 20% in people of European descent.
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PCV is characterised by abnormal blood vessels in the choroid, a thin layer of tissue between the sclera (the whites of the eyes) and the retina. These abnormal vessels can leak fluid or blood, leading to retinal damage and vision loss.
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People with PCV often experience blurred vision or a blind spot in or near the centre of their vision in one or both eyes.
9,10
Early diagnosis and treatment are important to help restore vision and prevent further vision loss.
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About SALWEEN
SALWEEN was a Phase IIIb/IV multicentre, open-label, single-arm study of Vabysmo for the treatment of Asian people with PCV. It enrolled 135 patients aged 50 years and over from 38 sites across nine markets in Asia, including China, Hong Kong SAR, India, Japan, Malaysia, Singapore, South Korea, Taiwan and Thailand. Patients received four loading doses of Vabysmo 6 mg over 12 weeks. After that, their treatment schedule was adjusted based on their progress, with doses given every eight, 12, or 16 weeks. From weeks 44 to 104, patients followed a personalised treatment plan with treatment intervals extended up to 20 weeks. The primary endpoint was the change from baseline in BCVA averaged over weeks 40-48.
1
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.
12-14
It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.
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Vabysmo is approved in more than 100 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema, and in more than 60 countries, including the US, EU and Japan, for people with macular edema following retinal vein occlusion (RVO).
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Review by other health authorities is ongoing.
About Roche in Ophthalmology
Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.
We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit
www.roche.com
.
All trademarks used or mentioned in this release are protected by law.
References
[1] Lai TYY, et al. Faricimab for Polypoidal Choroidal Vasculopathy (PCV): Two-Year Results From the SALWEEN Trial. Presented at: 19
th
Asia-Pacific Vitreo-retina Society (APVRS) Congress; August 28, 2026; Gold Coast, Australia.
[2] Cheung CMG. Macular neovascularization and polypoidal choroidal vasculopathy: phenotypic variations, pathogenic mechanisms and implications in management. Eye (Lond). 2024;38(4):659-667. doi:10.1038/s41433-023-02764-w.
[3] Wong 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(2):e106-e116. doi:10.1016/S2214-109X(13)70145-1.
[4] Macular Degeneration Facts & Figures. BrightFocus Foundation. [Internet; cited August 2026]. Available from:
https://www.brightfocus.org/macular/facts-figures/
.
[5] Pennington KL, DeAngelis MM. Epidemiology of age-related macular degeneration (AMD): associations with cardiovascular disease phenotypes and lipid factors. Eye Vis (Lond). 2016;3:34. doi:10.1186/s40662-016-0063-5.
[6] Little K, Ma JH, Yang N, Chen M, Xu H. Myofibroblasts in macular fibrosis secondary to neovascular age-related macular degeneration - the potential sources and molecular cues for their recruitment and activation. EBioMedicine. 2018;38:283-291. doi:10.1016/j.ebiom.2018.11.029.
[7] Connolly E, Rhatigan M, O'Halloran AM, et al. Prevalence of age-related macular degeneration associated genetic risk factors and 4-year progression data in the Irish population. Br J Ophthalmol. 2018;102(12):1691-1695. doi:10.1136/bjophthalmol-2017-311673.
[8] Cheung CMG, Lai TYY, Ruamviboonsuk P, et al. Polypoidal Choroidal Vasculopathy: Definition, Pathogenesis, Diagnosis, and Management. Ophthalmolog
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[9] Polypoidal Choroidal Vasculopathy. The Foundation of the American Society of Retina Specialists. [Internet; cited August 2026]. Available from:
https://www.asrs.org/patients/retinal-diseases/30/polypoidal-choroidal-vasculopathy
.
[10] Polypoidal Choroidal Vasculopathy. Scott E. Pautler, M.D. Tampa. [Internet; cited August 2026]. Available from:
https://www.scottpautlermd.com/polypoidal-choroidal-vasculopathy/
.
[11] Chawla H, Blair K, Vohra V. Polypoidal Choroidal Vasculopathy. In: Stat Pearls. Stat Pearls Publishing; March 16, 2023. [Internet; cited August 2026]. Available from:
http://www.ncbi.nlm.nih.gov/books/NBK567780/
.
[12] United States (US) Food and Drug Administration (FDA). Highlights of Prescribing Information, Vabysmo. April 2026. [Internet; cited August 2026]. Available from:
https://www.gene.com/download/pdf/vabysmo_prescribing.pdf
.
[13] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. May 17, 2022. [Internet; cited August 2026]. Available from:
https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative
.
[14] Heier JS, Khanani AM, Quezada Ruiz C, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022;399(10326):729-740. doi:10.1016/S0140-6736(22)00010-1.
[15] Wykoff CC, Abreu F, Adamis AP, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022;399(10326):741-755. doi:10.1016/S0140-6736(22)00018-6.
[16] European Medicines Agency. Summary of Product Characteristics, Vabysmo. August 2026. [Internet; cited August 2026]. Available from:
https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf
.
[17] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. March 26, 2024. [Internet; cited August 2026]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html
.
[18] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. March 28, 2022. [Internet; cited August 2026]. Available from:
https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html
.
[19] Roche data on file.
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Media Release SALWEEN APVRS English