Real-world VOYAGER data on faricimab in nAMD, DME, RVO at EURETINA 2026

New 12-month real-world data from the global VOYAGER study suggest that outcomes with faricimab-svoa (Vabysmo; Genentech) in routine practice are broadly consistent with those reported in its phase 3 trials, with treatment-naive eyes gaining vision and previously treated eyes maintaining or modestly improving vision alongside reductions in retinal thickness and fluid.¹ The findings, which span neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO), were presented at the 26th EURETINA Congress in Vienna, Austria, held October 1–4, 2026.^1-4

The data are of particular interest to retina specialists because much of faricimab's real-world use involves patients switched from other anti-vascular endothelial growth factor (VEGF) agents—a population that was largely excluded from, or underrepresented in, the pivotal trials.^5-7

Study design

VOYAGER (NCT05476926) is a prospective, noninterventional study of more than 5,000 patients initiating faricimab 6 mg for nAMD, DME, or RVO across 28 countries in Asia-Pacific, Europe, North America, and South America.^2-4 Treatment followed usual care, with no mandated visit schedule or imaging protocol.² Investigators collected visual acuity (VA) in Early Treatment Diabetic Retinopathy Study (ETDRS) letters, central subfield thickness (CST), investigator-determined subretinal fluid (SRF) and intraretinal fluid (IRF), and ocular safety events. A subset of spectral-domain optical coherence tomography (SD-OCT) scans was additionally analyzed using an in-house deep learning segmentation algorithm (ROSA) to quantify fluid volumes in the central 1-mm field.^3,4 All analyses were descriptive.^2-4

“The strength of VOYAGER lies in both its pragmatic design and its broad global inclusion,” Robin A. Vora, MD, a retina specialist at Kaiser Permanente Oakland Medical Center, said in an email interview with the Eye Care Network.

“By omitting protocol-driven appointment and imaging schedules, the study closely mirrors real-world community practice, including high-volume integrated health systems like Kaiser Permanente. Furthermore, by enrolling patients across 28 countries, the dataset aligns well with the diverse patient demographics we care for in Northern California.

As a result, the overall real-world outcomes across all three indications—wet AMD, DME, and RVO—closely resemble what we see in our practice, particularly within the previously treated (switch) population. Where real-world U.S. clinical practice differs from global observational trial data, however, is in the treatment-naïve cohort. In the U.S., insurance coverage preferences and mandated first-line step therapy (such as bevacizumab) often make it difficult for practices to immediately initiate newer generation agents in naïve eyes and, as such, not achieve the rapid early gains reported in VOYAGER.”

DME outcomes

In the DME cohort—reported in an abstract by Veeral Sheth, MD, and colleagues—506 treatment-naive and 413 previously treated eyes had at least 12 months of follow-up between November 2022 and January 2026.² Among treatment-naive eyes, mean VA improved from 64.1 to 71.1 letters, and mean CST decreased from 415.2 µm to 292.6 µm at month 12. The proportion of eyes with SRF fell from 17.3% to 2.4%, and IRF from 60.8% to 26.8%.² In previously treated eyes, VA rose from 66.9 to 69.1 letters and CST decreased from 367.6 µm to 314.2 µm; SRF fell from 10.6% to 4.1% and IRF from 46.3% to 39.1%.²

Injection frequency declined in the second half of the year, from a mean of 4.3 injections in months 1–6 to 2.1 in months 7–12 in treatment-naive eyes and from 4.1 to 2.7 in previously treated eyes.² Per-injection rates of intraocular inflammation (0.05%) and endophthalmitis (0.02%) were low and described by the authors as aligned with the phase 3 program.²

Genentech's announcement reported somewhat different DME figures, including a mean gain of 8.2 letters and a CST reduction of 127.8 µm in treatment-naive eyes and a 2.7-letter gain in previously treated eyes; the release did not specify the analysis population or explain the difference from the abstract Sheth presented at EURETINA.¹

A separate abstract led by Adrian Koh, MD, applied machine learning segmentation to DME scans from a smaller subset of 28 treatment-naive and 36 previously treated eyes from 14 countries.³ In treatment-naive eyes, mean total fluid volume decreased from 61.1 nL to 14.3 nL over 12 months, driven by reductions in both SRF and IRF. In previously treated eyes, total fluid fell from 46.7 nL to 26.5 nL, almost entirely through IRF reduction, while SRF volume was minimal and unchanged.³

nAMD outcomes

In nAMD, the company reported a mean VA gain of 4.6 letters and a CST reduction of 110.5 µm in treatment-naive eyes after 12 months and essentially stable VA (−0.1 letters) with a 26.1-µm CST reduction in previously treated eyes.¹ The proportion of treatment-naive eyes with SRF fell from 72.1% to 25.3%, and with IRF from 48.5% to 20.6%.¹

An imaging abstract led by Clare Bailey, MD, analyzed 136 treatment-naive and 174 previously treated nAMD eyes from 17 countries using the same segmentation approach.⁴ Among treatment-naive eyes, mean total fluid volume decreased from 33.1 nL to 3.7 nL and mean pigment epithelial detachment (PED) volume from 43.8 nL to 30.7 nL. In previously treated eyes, which began with lower fluid burden, total fluid decreased from 11.6 nL to 6.4 nL and PED volume from 63.1 nL to 52.7 nL.⁴ According to the release, eyes in both the nAMD and DME cohorts received fewer injections in months 7–12 than in months 1–6.¹

RVO outcomes

RVO results were reported at 6 months and only in the company release.¹ In branch RVO, treatment-naive eyes gained a mean of 10.0 letters with a 171.3-µm CST reduction, while previously treated eyes gained 2.0 letters with a 59.0-µm reduction. In central/hemiretinal RVO, treatment-naive eyes gained 16.6 letters with a 287.4-µm CST reduction, and previously treated eyes gained 3.9 letters with a 63.4-µm reduction.¹ Cohort sizes were not reported.

Context from the phase 3 program

Faricimab is a bispecific antibody that binds both VEGF-A and angiopoietin-2 (Ang-2); the Ang-2 component is thought to promote vascular stability, although its contribution to clinical response has not been established, according to the prescribing information.⁸ The US Food and Drug Administration (FDA) approved faricimab for nAMD and DME in January 2022 as the first bispecific antibody for the eye, followed by approval for macular edema after RVO in October 2023.^8,9

Approval was based on phase 3 trials demonstrating noninferiority to aflibercept 2 mg. In TENAYA and LUCERNE, treatment-naive patients with nAMD gained 5.8 and 6.6 letters, respectively, at the primary end point with dosing up to every 16 weeks.^5,8 In YOSEMITE and RHINE, patients with DME gained approximately 11 to 12 letters at year ^1.6,8 In BALATON (branch RVO) and COMINO (central/hemiretinal RVO), mean gains were 16.9 letters in each trial at week 24 with monthly dosing.^7,8 The 72-week extension of those trials evaluated treat-and-extend dosing, and the US label was updated in April 2026 to address RVO treatment beyond 6 months.^8,10

Direct comparison with the trials is limited. Pivotal-trial patients were newly diagnosed and largely treatment naive, whereas VOYAGER includes switched eyes with variable treatment histories and baseline characteristics. The release quoted Robyn Guymer, MBBS, PhD, chair of the VOYAGER steering committee and deputy director of the Centre for Eye Research Australia, who noted that patients in routine practice often do not meet the strict entry criteria of phase 3 trials.¹

Limitations

VOYAGER is a single-arm, observational study without a comparator, so the results cannot establish relative efficacy against other anti-VEGF agents. Treatment intervals and imaging were left to investigator discretion, and the abstracts report descriptive statistics only. Fluid presence in the main cohort was investigator-determined rather than centrally graded. The machine learning analyses involved a small fraction of the overall population, and the representativeness of those subsets was not described. The reduction in injections between months 1–6 and 7–12 partly reflects the loading phase and does not by itself establish extended treatment intervals.

Safety data in the abstracts are limited to per-injection rates of intraocular inflammation and endophthalmitis in the DME cohort.² Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, has been reported with faricimab in the postmarketing setting and is listed as a warning in the US label.⁸ Real-world data on these events were not reported in the materials reviewed.

The study's primary completion and full results, including longer-term durability and outcomes by prior treatment agent, have not yet been reported.

References

1. Genentech presents new data at EURETINA, highlighting Vabysmo's real-world effectiveness and safety across major retinal conditions. News release. Genentech. September 30, 2026. Accessed October 5, 2026. https://www.businesswire.com/news/home/20260930817201/en/

2. Sheth V, Lövestam Adrian M, Chaudhary V, et al. One-year clinical and anatomical outcomes of faricimab treatment in eyes with DME from the global, prospective observational VOYAGER study. Abstract presented at: 26th EURETINA Congress; October 1–4, 2026; Vienna, Austria.

3. Koh A, Finger R, Schmitz-Valckenberg S, et al. Anatomical outcomes of faricimab in patients with diabetic macular edema: 12-month real-world imaging from the VOYAGER study. Abstract presented at: 26th EURETINA Congress; October 1–4, 2026; Vienna, Austria.

4. Bailey C, Ishida S, Schmitz-Valckenberg S, et al. Anatomical outcomes of faricimab in patients with neovascular age-related macular degeneration: 12-month real-world imaging from the VOYAGER study. Abstract presented at: 26th EURETINA Congress; October 1–4, 2026; Vienna, Austria.

5. Heier JS, Khanani AM, Quezada Ruiz C, et al; TENAYA and LUCERNE Investigators. 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

6. Wykoff CC, Abreu F, Adamis AP, et al; YOSEMITE and RHINE Investigators. 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

7. Tadayoni R, Paris LP, Danzig CJ, et al; BALATON and COMINO Investigators. Efficacy and safety of faricimab for macular edema due to retinal vein occlusion: 24-week results from the BALATON and COMINO trials. Ophthalmology. 2024;131(8):950-960. doi:10.1016/j.ophtha.2024.01.029

8. Vabysmo (faricimab-svoa). Prescribing information. Genentech; revised April 2026. Accessed October 5, 2026. https://www.gene.com/download/pdf/vabysmo_prescribing.pdf

9. FDA approves Genentech's bispecific antibody for two leading causes of vision loss. News release. Genentech. January 28, 2022. Accessed October 5, 2026. https://www.gene.com/media/news-features/fda-approves-genentech-s-bispecific-antibody-for-two-leading-causes-of-vision-loss

10. Danzig CJ, Dinah C, Ghanchi F, et al; BALATON and COMINO Investigators. Faricimab treat-and-extend dosing for macular edema due to retinal vein occlusion: 72-week results from the BALATON and COMINO trials. Ophthalmol Retina. 2025;9(9):848-859. doi:10.1016/j.oret.2025.03.005