Genentech: VOYAGER shows Vabysmo effective and safe across wet AMD, DME and RVO
- VOYAGER enrolled more than 5,000 patients across 28 countries/regions and six continents as a prospective, non‑interventional real‑world study.
- Treatment‑naïve wet AMD at 12 months: +4.6 ETDRS letters and −110.5 µm CST; treatment‑naïve DME at 12 months: +8.2 ETDRS letters and −127.8 µm CST.
- Central/hemi‑RVO treatment‑naïve at 6 months showed the largest gains: +16.6 ETDRS letters and −287.4 µm CST.
- Safety profile was generally consistent with Phase III studies and no new safety signals were reported; AI imaging confirmed rapid anatomical drying and suggested interval extension.
Study scope and methods
VOYAGER is a global, prospective, non‑interventional real‑world study capturing data from more than 5,000 patients treated with Vabysmo across 28 countries/regions and six continents. The study uses AI and deep‑learning algorithms to evaluate SD‑OCT images collected in routine clinical practice.
Efficacy in wet AMD and DME (12 months)
In previously untreated wet AMD eyes mean change in visual acuity was +4.6 ETDRS letters with a CST reduction of −110.5 µm; previously treated wet AMD eyes showed stable vision (−0.1 letters) and CST −26.1 µm. In treatment‑naïve DME eyes mean VA improved by +8.2 letters with CST −127.8 µm, while previously treated DME eyes improved +2.7 letters with CST −71.3 µm. Presence of subretinal and intraretinal fluid declined across these cohorts, and fewer injections were delivered during months 7–12 versus months 1–6 in wet AMD and DME.
RVO outcomes (6 months)
Branch RVO treatment‑naïve eyes improved +10.0 ETDRS letters with CST −171.3 µm; previously treated branch RVO eyes improved +2.0 letters with CST −59.0 µm. Central/hemi‑RVO treatment‑naïve eyes improved +16.6 letters with CST −287.4 µm; previously treated central/hemi‑RVO eyes improved +3.9 letters with CST −63.4 µm. SRF and IRF frequencies declined across RVO subtypes.
Safety and clinical implications
The Vabysmo safety profile in VOYAGER was generally consistent with Phase III studies and no new safety signals were identified. AI‑enabled imaging analysis demonstrated rapid and meaningful anatomical drying, supporting Vabysmo’s utility in routine practice and suggesting potential for extended treatment intervals.
Source: Genentech