Given the new STAIRWAY data, faricimab becomes the first investigational treatment for wet AMD to achieve confirmed 16-week dosing for the majority of patients in a clinical trial. The potential of more durable every 16-week dosing is considered important because other investigational drugs for wet AMD have recently shown efficacy at 12-week retreatment intervals, while Eylea (aflibercept; Regeneron) and Lucentis have been approved for 12-week dosing based on physician assessment.
“Because current anti-VEGF monotherapies for wet AMD are burdensome, requiring frequent clinic visits for eye injections, some people are undertreated and experience subsequent declining vision over time,” said Sandra Horning, MD, chief medical officer and head of Global Product Development in a news release. “The STAIRWAY data show the potential of faricimab to allow fewer injections while achieving and sustaining the same visual gains seen with a current standard of care. Based on these data, we will be initiating a global phase 3 program for faricimab in wet AMD.”
Patients in the STAIRWAY study were treated with either faricimab 6 mg every 12 weeks or every 16 weeks, or ranibizumab 0.5 mg every 4 weeks. After 52 weeks treatment, the average visual acuity gains for each treatment group were as follows:
- +11.4 letters with faricimab 16-week dosing
- +10.1 letters with faricimab 12-week dosing
- +9.6 letters with ranibizumab 4-week dosing
Arshad Khanani, MD, MA, of Sierra Eye Associates, Reno, Nevada, who presented the STAIRWAY data at the recent AAO meeting, said the unique bispecific nature of faricimab should be seen as a key advantage of the drug.
“The Ang2 inhibition offered by faricimab contributes to vascular stabilization and decreases microvascular inflammation, which may contribute to extended durability,” he said.
Faricimab is now in 2 large-scale clinical trials for DME.