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Roche announced 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). 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.
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. In RVO, both subtypes of the disease showed improvements in efficacy in people treated with Vabysmo. In the central/hemi-RVO cohort, vision and CST improved in both previously untreated and treated eyes after six months of Vabysmo therapy. 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. 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. 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. 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.
VOYAGER is the largest global, prospective, non-interventional real-world study of Vabysmo (faricimab). 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). The study leverages state-of-the-art AI and deep learning algorithms to evaluate SD-OCT images captured during routine clinical practice.
Vabysmo is the first bispecific antibody approved for the eye. 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. 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). Review by other health authorities is ongoing.
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