Faricimab VOYAGER Study

Early results from VOYAGER—a global, prospective, non-interventional study evaluating outcomes of faricimab for treating naïve neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME) in clinical practice—show improvements in functional and anatomical measures as well as no new safety concerns, reports Clare Bailey MD.

“With a planned enrolment of more than 5,000 patients, VOYAGER is distinguished by its huge size,” Dr Bailey said. “Its results will provide insights on outcomes in a heterogeneous population of patients initiating faricimab treatment in routine clinical practice, and the data will produce highly generalisable findings.”

VOYAGER is enrolling patients in 28 countries in Europe, the Middle East, Africa, North and South America, and the Asia-Pacific region and plans to collect clinical data for up to 5 years. Discussing findings from a preliminary analysis, Dr Bailey reported on patients with 6 months of follow-up, including data on baseline demographic characteristics and changes in ETDRS visual acuity (VA), central subfield thickness (CST), and percentages of eyes with physician-determined subretinal and intraretinal fluid (SRF and IRF, respectively).

“VOYAGER is also collecting data from OCT, and we expect there will be a lot of interesting findings coming out from interpreting the OCT data,” Dr Bailey said.

The findings Dr Bailey reported were from 120 treatment-naïve eyes (119 patients) with nAMD and 67 eyes (51 patients) with treatment-naïve DME. At baseline, the nAMD patients had a mean age of 80 years, 66% were female, the highest proportion were recruited from Europe (44.5%), and the majority were white and not Hispanic or Latino (54%). Baseline characteristics of the 51 DME patients showed a mean age of 59 years, 37% were female, the highest proportion were from Australia (45%), and the majority were white and not Hispanic or Latino (57%).

At the 6-month follow-up, mean number of injections for both the nAMD and DME groups was 4.7.

“In the real world, many ophthalmologists administer four [monthly] injections of faricimab, per the label’s recommendation,” she said. “Longer follow-up in VOYAGER is needed to show what interval extensions and durability can be demonstrated.”

Focusing on the nAMD cohort, she reported the mean VA was 57.9 letters at baseline, which increased by a mean of 3.5 letters at month 6. Mean CST reduced from 344.3 microns at baseline to 263.8 microns at month 6 (mean change -85 microns).

Physician-determined SRF was present in 69.8% of eyes with nAMD at baseline and only 25.9% of eyes at month 6, while the percentage of eyes with physician-determined IRF decreased from 62.7% at baseline to 15.8% in the same period.

In the eyes with DME, mean VA was 62.1 letters at baseline, and they showed a mean gain of 7.2 letters at month 6, whereas their CST fell by a mean of 150 microns from the mean baseline value of 425.8 to 274.6 microns.

Physician-determined SRF was present in 29.8% of DME eyes at baseline and only 3.7% at the follow-up. Almost all DME eyes (98.2%) had physician-determined IRF at baseline, and the percentage fell to 72.7% at month 6.

Dr Bailey reported these results at EURETINA 2024 in Barcelona.

Clare Bailey MD is a consultant ophthalmologist at Bristol Eye Hospital, Bristol, England, UK. clare.bailey@uhbw.nhs.uk