EURETINA 2024: The global VOYAGER study provides real-world, scalable findings

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The European Society of Retina Specialists (EURETINA) Congress drew ophthalmologists from around the world to beautiful Barcelona, Spain, for its annual meeting. At the meeting, Clare Bailey, MD, presented research findings that matched the conference’s global mood.

As part of the clinical trial results session, Bailey presented clinical and anatomical outcomes of faricimab from the VOYAGER study (NCT05476926), focusing on treatment-naïve patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME). In conversation with Ophthalmology Times Europe, Bailey explained the data and shared information on the patient selection and enrollment process.

Hattie Hayes: Can you give me an overview of the data you discussed at this year’s EURETINA meeting? I’d love a particular focus on outcomes for patients with diabetic macular edema.

Clare Bailey, MD: Of course, I am delighted to share the data. VOYAGER is an innovative, multi-country study evaluating the long-term effectiveness and safety of Vabysmo (faricimab) in nAMD and DME in routine clinical practice. This presentation shows results for eyes with at least 6 months follow-up to date. In patients with DME, results showed that vision outcomes improved, as measured by increases in mean visual acuity from baseline to month six by +7.2 ETDRS letters.

This study also collected data on central subfield thickness (CST) in nAMD and DME patients. For DME patients, CST decreased by an average of 150.4 microns, indicating retinal drying. Clinicians reported a reduction in sub-retinal fluid, present in 29.8% of DME eyes at baseline and 3.7% at 6 months. There was also a reduction in clinician-reported intraretinal fluid, present in 98.2% of DME eyes at baseline and in 72.7% after 6 months. No new safety concerns were identified in this study.

HH: One interesting aspect of these results is that they showcase how faricimab performs across different global patient populations. What can you share about the trial design process, and how patient groups were selected?

CB: The VOYAGER trial was designed to capture diverse global patient populations and included patients with nAMD and DME in 28 countries across North America, Australia, Europe and the Middle East. This includes countries that were not included in the Phase III clinical trials.

The selection process focused on enrolling a representative mix of patients being treated with Vabysmo for nAMD and DME, ensuring broad applicability of the findings. The global VOYAGER study will collect widely generalisable data on the effectiveness, safety and durability of Vabysmo in clinical practice.

HH: What are the key takeaways from this presentation you hope clinicians at the EURETINA meeting will bring to their patients’ post-conference?

CB: VOYAGER is an innovative global, prospective, non-interventional study underway in 26 out of a planned 28 countries, to collect data in patients receiving faricimab for nAMD or DME. Results from VOYAGER will provide insights on outcomes in patients initiating Vabysmo treatment in routine clinical practice, and the presentation at EURETINA shows the 6-month outcomes to date for eyes with nAMD and DME in this study. The collection of data from VOYAGER will provide information on a heterogeneous population of patients, with at least 5000 patients to be recruited, and will produce highly generalisable findings.