Voyager study provides data on real-world effectiveness of faricimab for nAMD and DME

The study's primary objective is to evaluate the effectiveness of faricimab used according to its approved retinal indications on visual acuity at 12 months in the real-world setting. Image credit: ©SasinParaksa – stock.adobe.com

Reviewed by Robyn Guymer, MBBS, PhD

The Voyager Study is a noninterventional, prospective, multinational, multicentre study with the goal of determining how faricimab (Vabysmo, Genentech) fares in the real world in patients with neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME).

Robyn Guymer, MBBS, PhD, from the Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, University of Melbourne, Melbourne, Australia, reported the study’s preliminary data on behalf of the Voyager investigators at the Angiogenesis, Exudation, and Degeneration conference, sponsored by Bascom Palmer Eye Institute, Miami.

A minimum of 5,000 patients with up to 5 years of follow-up will be included in the study. The patients will be from a variety of practice settings and clinician experiences in 28 countries and 500 sites. All patients are adults being treated with faricimab for nAMD or DME.

The primary objective is to evaluate the effectiveness of faricimab used according to its approved retinal indications on visual acuity (VA) at 12 months in the real-world setting. The secondary objectives are to evaluate the effectiveness of faricimab for approved indications on VA at specified intervals during the study; describe retinal treatment patterns and philosophies (fluid tolerance, definitions of active disease); and evaluate changes in VA over time in relation to treatment number/patterns, investigator-determined disease activity, fluid presence/location, and presence and location of nAMD- and DME-specific anatomic features that influence vision such as fibrosis, atrophy, and disorganised inner retinal layers.

Preliminary data

The preliminary data were from sites in the US, Canada and Japan. Data were reported for 220 eyes of 174 patients with nAMD and 107 eyes of 69 patients with DME.

Most of the eyes of patients with nAMD and DME had been treated before enrollment in the study with an anti-vascular endothelial growth factor (VEGF), including faricimab. Over 65% of eyes had been last treated with faricimab before study enrollment, ie, 71.9% of eyes with nAMD and 66.3% of eyes with DME.

Guymer reported that the VA Increased from baseline to month 3 in nAMD and DME in patients who had switched to faricimab at enrollment from ranibizumab (Lucentis, Genentech), aflibercept (Eylea, Regeneron Pharmaceuticals), brolucizumab (Beovu, Novartis) or other anti-VEGF agents.

The central subfield thickness decreased rapidly in patients with nAMD and DME who switched to faricimab at study enrollment in both nAMD and DME from baseline to month 3.

The data also showed that investigator tolerance of fluid was disease-dependent and treat-and-extend regimens were preferred.

In addition, there were no new safety concerns.

Future analyses of VOYAGER data

The primary endpoint is the change in the VA from baseline to 1 year.

The secondary and exploratory analyses include interpretation of anatomic features and the impact on treatment, the impact of treatment regimens/philosophies on outcomes, the drivers of treatment decisions and imaging algorithms developed to assess key features impacting the VA. Thus far, 5,863 images are available.

The next data analysis will include data from more countries.

“VOYAGER will provide new insights on the clinical use of faricimab that will allow a deep understanding of strategies to improve outcomes globally for nAMD and DME,” Guymer concluded.