Roche: VOYAGER real‑world data confirm Vabysmo effectiveness and safety in nAMD, DME and RVO

Study scope

VOYAGER is a global, prospective, non‑interventional real‑world study of faricimab (Vabysmo) that captured data from more than 5,000 patients across 28 countries/regions and six continents, covering neovascular AMD (nAMD), diabetic macular edema (DME) and retinal vein occlusion (RVO). The study used AI and deep‑learning analysis of routine SD‑OCT imaging to evaluate anatomical outcomes.

Clinical outcomes

At 12 months, previously untreated nAMD and DME eyes showed vision gains and marked central subfield thickness (CST) reductions, while previously treated eyes had stable or improved vision with anatomical improvement. Key results included nAMD untreated +4.6 ETDRS letters (−110.5 µm CST) and DME untreated +8.2 letters (−127.8 µm CST). In RVO cohorts at six months, branch RVO untreated eyes gained +10.0 letters (−171.3 µm CST) and central/hemi‑RVO untreated eyes gained +16.6 letters (−287.4 µm CST).

Durability and imaging

Across cohorts the presence of subretinal fluid (SRF) and intraretinal fluid (IRF) was consistently reduced in both untreated and treated eyes. In the nAMD and DME groups, fewer Vabysmo injections were administered during months 7–12 versus months 1–6, suggesting extension of treatment intervals. AI‑enabled imaging analysis supported rapid and meaningful anatomical drying.

Safety

The Vabysmo safety profile in VOYAGER was generally consistent with Phase III studies in nAMD, DME and RVO, with no new safety signals reported in the dataset.