Roche presents new data at EURETINA, highlighting Vabysmo’s real-world effectiveness and safety across major retinal conditions
2026-10-01
- New real-world results for Vabysmo in nAMD, DME and RVO reinforce robust effectiveness and durability across previously untreated and treated eyes, with no new safety signals1-3
- Advanced AI-enabled analysis of imaging confirms rapid and meaningful anatomical drying supporting Vabysmo as a standard-of-care therapy in routine clinical care4,5
- With more than 5,000 patients enrolled, VOYAGER is the largest, prospective, non-interventional real-world dataset evaluating Vabysmo across diverse clinical practice settings worldwide1-3
Basel, 1 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new data from the VOYAGER study evaluating the effectiveness, durability and safety of Vabysmo® (faricimab) in neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).1-3 Across all study cohorts, results confirm the real-world effectiveness of Vabysmo in line with Phase III trial results, with vision gains and robust anatomical improvements in untreated eyes and stable or improved vision with improved anatomical outcomes in previously treated eyes.1-3
In the nAMD and DME cohorts of the study, vision and central subfield thickness (CST) improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after 12 months of Vabysmo treatment.1,2 In RVO, both subtypes of the disease showed improvements in efficacy in people treated with Vabysmo.3 In the central/hemi-RVO cohort, vision and CST improved in both previously untreated and treated eyes after six months of Vabysmo therapy.3 In the branch RVO cohort, vision and CST improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after six months of Vabysmo treatment.3 The data are being presented at the EURETINA 2026 Annual Meeting in Vienna, Austria.
“These real-world results underscore how the efficacy and safety observed in our pivotal Vabysmo studies translate directly into routine clinical practice globally,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The sustained visual improvements and meaningful anatomical drying seen in the VOYAGER study reinforce the role of Vabysmo in helping to address important unmet needs for patients with retinal conditions.”
“In daily clinical practice, we manage diverse patient populations with complex treatment histories who don’t always mirror the strict entry criteria of controlled Phase III trials.” said Professor Robyn Guymer, Chair of the VOYAGER Steering Committee and Deputy Director of the Centre for Eye Research Australia. “The latest VOYAGER data give physicians from across the world the confidence that Vabysmo delivers sustained visual gains, meaningful anatomical drying, and an established safety profile in everyday practice – whether a patient is starting treatment for the first time or transitioning from another therapy.”
The new VOYAGER real-world data in nAMD, DME and RVO are consistent with previous Phase III study results and demonstrate the effectiveness, durability and safety of Vabysmo across diverse global practices.1-3 Across all cohorts of the study, the presence of subretinal fluid (SRF) or intraretinal fluid (IRF) was consistently reduced in previously untreated and treated eyes.1-3 In the nAMD and DME groups, fewer Vabysmo injections were received during months 7-12 compared with months 1-6, suggesting extension of treatment intervals.1,2
| Mean change in visual acuity (VA) Early Treatment Diabetic Retinopathy Study (ETDRS) letters | Mean change in central subfield thickness (CST) µm | Presence of subretinal fluid (SRF) % of eyes | Presence of intraretinal fluid (IRF) % of eyes | |
| nAMD (after 12 months of Vabysmo treatment)1 | ||||
| No prior treatment | +4.6 | –110.5 | 72.1→25.3 | 48.5→20.6 |
| Previously treated | -0.1 | -26.1 | 61.6→37.9 | 35.4→25.0 |
| DME (after 12 months of Vabysmo treatment)2 | ||||
| No prior treatment | +8.2 | -127.8 | 26.5→6.8 | 87.3→58.1 |
| Previously treated | +2.7 | -71.3 | 22.1→9.3 | 80.5→68.1 |
| Branch RVO (after 6 months of Vabysmo treatment)3 | ||||
| No prior treatment | +10.0 | -171.3 | 36.3→11.8 | 83.8→50.0 |
| Previously treated | +2.0 | -59.0 | 15.9→6.6 | 82.6→80.3 |
| Central/hemi-RVO (after 6 months of Vabysmo treatment)3 | ||||
| No prior treatment | +16.6 | -287.4 | 50.7→9.8 | 85.7→29.4 |
| Previously treated | +3.9 | -63.4 | 14.9→10.3 | 89.4→74.4 |
In VOYAGER, the Vabysmo safety profile was generally consistent with that established in the Phase III studies in nAMD, DME and RVO.1-3
About VOYAGER
VOYAGER is the largest global, prospective, non-interventional real-world study of Vabysmo (faricimab).1-3 It captures real-world data from 28 countries/regions across six continents representing more than 5,000 patients treated for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME) or retinal vein occlusion (RVO).1-3 The study leverages state-of-the-art AI and deep learning algorithms to evaluate SD-OCT images captured during routine clinical practice.4-6
About Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.7-9 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.9,10 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).7,8,11-14 Review by other health authorities is ongoing.
About Roche in Ophthalmology
At Roche, we are on a mission to save and restore eyesight. Over 330 million people around the world are blind, or living with vision loss, creating a profound personal and socioeconomic burden. With the broadest pipeline in Ophthalmology, we continue to invest at scale to redefine what is medically possible in eye care.
Our comprehensive ophthalmology pipeline integrates diverse targets, advanced delivery systems, cell and gene therapies, and AI-augmented imaging capabilities, 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.
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References
[1] Guymer R, et al. One-year Clinical and Anatomical Outcomes of Faricimab Treatment in Eyes With nAMD From the Global, Prospective Observational VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[2] Sheth V, et al. One–Year Clinical and Anatomical Outcomes of Faricimab Treatment in Eyes With DME From the Global, Prospective Observational VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[3] Hattenbach L-O, et al. Real-World Clinical and Anatomical Outcomes With Faricimab in Patients With Retinal Vein Occlusion From a Global, Prospective Observational Study: The VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[4] Bailey C, et al. Anatomical Outcomes of Faricimab in Patients with Neovascular Age-Related Macular Degeneration: 12-Month Real-World Imaging from the VOYAGER Study. Presented at:26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[5] Koh A, et al. Anatomical Outcomes of Faricimab in Patients with Diabetic Macular Edema: 12-Month Real-World Imaging from the VOYAGER Study. Presented at: 26th EURETINA Congress; 1–4 October 2026; Vienna, Austria.
[6] Guymer R, Bailey C, Chaikitmongkol V, et al. Rationale and Design of VOYAGER: Long-term Outcomes of Faricimab and Port Delivery System with Ranibizumab for Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema in Clinical Practice. Ophthalmol Sci. 2024;4(3):100442. doi:10.1016/j.xops.2023.100442.
[7] United States (US) Food and Drug Administration (FDA). Highlights of Prescribing Information, Vabysmo. April 2026. [Internet; cited September 2026]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761235s008lbl.pdf
[8] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. May 17, 2022. [Internet; cited September 2026]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative
[9] 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.
[10] 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.
[11] European Medicines Agency. Summary of Product Characteristics, Vabysmo. August 2026. [Internet; cited September 2026]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
[12] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited September 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
[13] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. [Internet; cited September 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[14] Roche data on file.
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