Results from the phase 2 STAIRWAY study of faricimab in patients with wet age-related macular degeneration (AMD) indicate that patients dosed with faricimab either every 16 weeks or every 12 weeks demonstrated sustained vision outcomes comparable to those of patients dosed with ranibizumab every 4 weeks.
Results of the phase 2 study were presented at a late-breaking session during the 2018 American Academy of Ophthalmology Annual Meeting in Chicago, Illinois.
“Because current anti-VEGF monotherapies for wet AMD are burdensome, requiring frequent clinic visits for eye injections, some people are under-treated and experience subsequent declining vision over time,” said Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, in a statement. “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.”
The 52-week STAIRWAY study assessed 2 extended dosing regimens of faricimab 6 mg—given either every 16 weeks or every 12 weeks—compared to ranibizumab .5 mg given every 4 weeks. Treatment-naïve patients with wet AMD (n = 76) were randomized to the 3 study arms.
At 24 weeks, participants randomized to the 16-week dosing regimen were switched to 12-week schedule if they were determined to have active disease according to pre-defined criteria. At week 24, 65 % (36 of 55) of participants treated with faricimab had no active disease.
Vision gains, as measured by Best Corrected Visual Acuity (BCVA), were sustained through week 52 for participants receiving both the 16- and 12-week faricimab regimens. Those treated every 16 weeks had a mean improvement of 11.4 letters from baseline, compared to 10.1 letters in the 12-week group, and 9.6 letters in the ranibizumab 4-week group.
All 3 treatment arms were similar in the rates of patients both gaining more that 15 letters as well as avoiding the loss of over 15 letters. Additionally, all 3 treatment arms had comparable reductions in central retina thickness.
Rates of both ocular and systemic adverse events were similar in both the faricimab and ranibizumab groups. There were no new safety signals observed and the overall safety profile of faricimab is consistent with that of intravitreal injections of anti-VEGF therapies in patients with wet AMD.
“Based on these data, we will be initiating a global phase 3 program for faricimab in wet AMD,” added Horning.
The company plans to start this global phase 3 program to study faricimab in patients with wet age-related macular degeneration in 2019. Currently, there are 2 phase 3 studies of faricimab enrolling participants: RHINE and YOSEMITE are designed to evaluate the efficacy and safety of faricimab compared to aflibercept in treating diabetic macular edema (DME).