Roche announce positive results from the phase II STAIRWAY study which explored the extended durability of faricimab in nAMD.
STAIRWAY explored the extended durability of faricimab (RG7716) in the treatment of neovascular (“wet”) age-related macular degeneration (nAMD), a leading cause of blindness globally in people aged 60 and over.
At 52 weeks, faricimab patients dosed either every 16 weeks or every 12 weeks demonstrated sustained vision outcomes comparable to ranibizumab dosed every four weeks.
STAIRWAY is a 52 week study that assessed two extended dosing regimens of faricimab 6.0mg given every 16 weeks or every 12 weeks, compared to ranibizumab 0.5 mg every four weeks. At week 24, 65% (n=36/55) of people treated with faricimab had no active disease, highlighting the potential of 16 week dosing in nearly two-thirds of patients. Initial vision gains, as measured by Best Corrected Visual Acuity (BCVA), were fully maintained through to week 52 with both 16 and 12 week dosing regimens. People treated with faricimab dosed every 16 weeks experienced a mean improvement of 11.4 letters from baseline, compared to 10.1 letters in patients treated with faricimab dosed every 12 weeks, and 9.6 letters in patients treated with 0.5 mg ranibizumab dosed every four weeks. Comparable reductions in central retina thickness were also observed in people treated with both dosing intervals of faricimab and those treated with ranibizumab. Faricimab was well tolerated with no new safety signals observed.
In addition, data on the investigational Port Delivery System with ranibizumab (PDS) in patients with nAMD were also presented at the AAO Annual Meeting, comprising further data from the phase II Ladder study, and the trial design of the phase III Archway study. The small, refillable eye implant, which is slightly longer than a grain of rice, is designed to allow most people with nAMD to go six months without needing a refill.
Allergan have released their clinical trial results for abicipar where they assessed the efficacy and safety of abicipar compared with ranibizumab in treatment-naïve patients with neovascular age-related macular degeneration (AMD).
Topline results presented earlier this year showed the majority of PDS patients – including approximately 80% of patients in the high-dose PDS group – went six months or longer between the implantation and the first required refill of the device. Importantly, patients in the high-dose PDS group achieved similar visual outcomes as 0.5 mg ranibizumab dosed every four weeks.
Faricimab in nAMD and the PDS are the two most advanced investigational treatments in Roche’s robust ophthalmology pipeline. In addition to Archway, two pivotal phase III studies for faricimab are currently open and enrolling: RHINE and YOSEMITE.
Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development said, “Because current anti-VEGF monotherapies for neovascular AMD are burdensome, requiring frequent clinic visits for eye injections, some people are under-treated and experience subsequent declining vision over time. 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 III programme for faricimab in nAMD.”