Roche’s faricimab meets primary endpoint and shows strong durability across two global phase III studies for diabetic macular edema, a leading cause of blindness

Faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks in both studiesMore than half of participants in the faricimab personalised dosing arms had extended time between treatments to 16 weeks at year one – the first time this level of durability has been achieved in a phase III diabetic macular edema studyFaricimab is the first investigational bispecific antibody designed for the eye and targets two distinct pathways – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) – that drive a number of retinal conditionsFaricimab was generally well-tolerated, with no new safety signals identifiedBasel, 21 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two identically designed global phase III studies, YOSEMITE and RHINE, evaluating its investigational bispecific antibody, faricimab, in people living with diabetic macular edema (DME). Both studies met their primary endpoint and showed that faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks. Faricimab was generally well-tolerated, with no new safety signals identified. The studies each have three treatment arms, with participants randomised to receive either faricimab or aflibercept at fixed eight-week intervals, or faricimab at personalised intervals of up to 16 weeks, following a loading phase.
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