Roche’s VOYAGER study shows real-world visual and anatomical improvements with Vabysmo in nAMD, DME and RVO across previously treated and untreated eyes.
Written By: Malavatu Satvika, PharmD
Reviewed By: Pharmacally Editorial Team
Roche presented new data from the VOYAGER study at the EURETINA 2026 Annual Meeting in Vienna, Austria, 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).
The global prospective, non-interventional study has enrolled more than 5,000 patients across 28 countries and regions. The findings showed improvements in vision and retinal anatomy among previously untreated eyes, while previously treated eyes generally maintained or improved vision alongside anatomical improvements.
A Global Real-World Evidence Study
VOYAGER (NCT05476926) is a prospective, non-interventional, multinational study designed to collect long-term real-world data on Roche ophthalmology products in routine clinical practice. The study includes patients with nAMD, DME and RVO and evaluates treatment outcomes, safety and treatment patterns.
Vabysmo is a bispecific antibody that neutralizes angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), two signaling pathways associated with abnormal blood vessel formation and vascular leakage in retinal disease.
Visual and Anatomical Outcomes in nAMD and DME
After 12 months of Vabysmo treatment, previously untreated eyes with nAMD showed a mean improvement of 4.6 Early Treatment Diabetic Retinopathy Study (ETDRS) letters and a 110.5 µm reduction in central subfield thickness (CST). In previously treated eyes, visual acuity was essentially maintained, with a mean change of −0.1 ETDRS letters, while CST decreased by 26.1 µm.
In DME, previously untreated eyes showed a mean gain of 8.2 ETDRS letters and a 127.8 µm reduction in CST after 12 months. Previously treated eyes showed a mean gain of 2.7 letters and a 71.3 µm reduction in CST.
Reductions in subretinal fluid (SRF) and intraretinal fluid (IRF) were also observed across the nAMD and DME cohorts, providing additional evidence of anatomical improvement. Fewer Vabysmo injections were administered during months 7–12 than during months 1–6 in the nAMD and DME cohorts, suggesting that treatment intervals may be extended for some patients in routine clinical practice.
Findings in Retinal Vein Occlusion
In branch RVO, previously untreated eyes showed a mean improvement of 10.0 ETDRS letters and a 171.3 µm reduction in CST after six months of Vabysmo treatment. Previously treated eyes showed a mean gain of 2.0 letters, while CST decreased by 59.0 µm.
In central or hemi-RVO, previously untreated eyes showed a mean gain of 16.6 ETDRS letters and a 287.4 µm reduction in CST. Previously treated eyes showed a mean gain of 3.9 letters and a 63.4 µm reduction in CST after six months.
Reductions in SRF and IRF were also observed across the RVO cohorts, supporting the anatomical improvements reported with treatment.
AI-Enabled Retinal Imaging
VOYAGER incorporates artificial intelligence and deep-learning algorithms to analyse spectral-domain optical coherence tomography (SD-OCT) images collected during routine clinical practice.
The AI-enabled analysis showed rapid anatomical drying across the evaluated retinal conditions. Reductions in the presence of SRF and IRF were observed in both previously untreated and previously treated eyes, providing additional information on the anatomical response to Vabysmo in real-world clinical settings.
Safety Profile Consistent with Previous Studies
The safety profile of Vabysmo in VOYAGER was generally consistent with the safety profile established in previous Phase III studies in nAMD, DME and RVO. No new safety signals were reported in the VOYAGER data presented at EURETINA 2026.
Roche Perspective
Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said the real-world findings demonstrate how the efficacy and safety observed in pivotal Vabysmo studies translate into routine clinical practice globally.
The VOYAGER findings add to the real-world evidence supporting the use of Vabysmo across nAMD, DME and RVO, including in patients who had received previous treatment.
Path Forward
With more than 5,000 patients enrolled across 28 countries and regions, VOYAGER provides real-world information on visual outcomes, retinal anatomy, safety and treatment patterns across major retinal conditions.
Further follow-up from the ongoing study is expected to provide additional information on the longer-term effectiveness, safety and treatment patterns associated with Vabysmo in routine clinical practice.
Reference
Roche presents new data at EURETINA, highlighting Vabysmo’s real-world effectiveness and safety across major retinal conditions, Roche, 01 October 2026
A Real-World Study to Gain Clinical Insights into Roche Ophthalmology Products (VOYAGER), ClinicalTrials.gov ID NCT05476926
About the Writer
Malavatu Satvika (Linkedin) is a Pharm.D professional and aspiring healthcare medical writer with clinical exposure and research experience. Her interests include medical writing, drug safety, pharmaceutical research, and evidence-based healthcare communication. She has contributed to two research publications in pharmaceutical journals and has gained practical experience in prescription review, patient counselling, medication review, adverse drug reaction monitoring, drug information services, literature review, and clinical documentation through regular hospital training.
She has completed certifications in clinical research, ICH-GCP E6(R3), data management for clinical research, and congenital hypothyroidism. With a strong foundation in pharmacy, clinical practice, and scientific research, she aims to translate complex medical and pharmaceutical information into accurate, clear, and evidence-based healthcare content. She is also preparing to pursue a PhD and further develop her expertise in medical writing and pharmaceutical research.