Article

Faricimab 16-Week Efficacy at 1 Year Confirmed

A 6-mg dose shows no new safety concerns.

 New data presented at the recent AAO meeting confirms earlier projections that a 6-mg dose of Genentech’s bispecific anti-VEGF/anti-Ang2 faricimab (formerly RG7716) delivered every 16 weeks can on average provide as good or better vision gains than Lucentis (ranibizumab; Genentech) administered every 4 weeks. The 1-year data were from Genentech’s phase 2 STAIRWAY study made up of 76 treatment-na├»ve patients with wet AMD.

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
Among the 3 treatment groups, the proportion of patients gaining more than 15 letters, the proportion of patients avoiding a loss of more than 15 letters, and reductions in central retina thickness were comparable. The rates of ocular and systemic adverse events observed with faricimab were similar to the rates observed with ranibizumab. No new safety signals were observed. The overall safety profile of faricimab appears consistent with the safety profile reported in patients with wet AMD who receive intravitreal anti-VEGF therapies.

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.