Roche has reported that results from four Phase III studies showed faricimab to offer non-inferior vision gains for the treatment of diabetic macular oedema (DME) and neovascular or ‘wet’ age-related macular degeneration (nAMD).
An investigational bispecific antibody designed for the eye, faricimab targets two pathways via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) that drive various retinal conditions.
The identical, randomised, multi-centre, double-masked, global Phase III YOSEMITE and RHINE studies analysed the efficacy and safety of faricimab versus aflibercept in 1,891 individuals with DME.
Similar Phase III TENAYA and LUCERNE studies analysed the efficacy and safety of faricimab versus aflibercept in 1,329 individuals with nAMD.
The studies consistently showed that faricimab, given at intervals of up to four months, offered non-inferior vision gains compared to aflibercept given every two months.
In the DME and nAMD studies, around half of the individuals eligible for extended dosing with faricimab could be treated every four months in the first year.
Roche noted that the investigational antibody is the first injectable eye medicine to meet this length of time between treatments in Phase III studies for DME and nAMD.
Furthermore, about three quarters of individuals eligible for extended dosing with the antibody could be treated every three months or longer in the first year.
Faricimab demonstrated fast and consistent improvements in anatomical outcomes, including central subfield thickness, across all studies. It was generally well-tolerated, with no new or unexpected safety signals noted.
Roche chief medical officer and Global Product Development head Levi Garraway said: “These positive results show the potential for faricimab as the first new type of medicine in 15 years for people with neovascular age-related macular degeneration and in close to a decade in diabetic macular oedema.
“This is an exciting time for our ophthalmology clinical development programme, with multiple phase III successes for two medicines from our late-stage pipeline.”
Last December, Roche announced positive topline results from two identically designed global phase III studies of its investigational bispecific antibody, faricimab, to treat people with DME.