Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials

Background:To reduce treatment burden and optimise patient outcomes in diabetic macular oedema,we present 1-year results from two phase 3 trials of faricimab,a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody.Methods:YOSEMITE and RHINE were randomised,double-masked,non-inferiority trials across 353 sites worldwide.Adults with vision loss due to centre-involving diabetic macular oedema were randomly assigned(1:1:1)to intravitreal faricimab 6.0 mg every 8 weeks,faricimab 6.0 mg per personalised treatment interval(PTI),or aflibercept 2.0 mg every 8 weeks up to week 100.PTI dosing intervals were extended,maintained,or reduced(every 4 weeks up to every 16 weeks)based on disease activity at active dosing visits.The primary endpoint was mean change in best-corrected visual acuity at 1 year.