Roche’s faricimab meets primary endpoint in two global phase III studies and shows potential to extend time between treatments up to 16 weeks for people with neovascular age-related macular degeneration

Faricimab given at intervals of up to every 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks, potentially reducing the frequency of injections and overall burden of treatmentNearly half of people were treated with faricimab every 16 weeks during the first year – the first time this level of durability has been achieved in a phase III study of an injectable eye medicine for neovascular age-related macular degenerationFaricimab 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 in both studies, with no new or unexpected safety signals identifiedBasel, 25 January 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results from two identically designed global phase III studies, TENAYA and LUCERNE, evaluating its investigational bispecific antibody, faricimab, in people living with neovascular or “wet” age-related macular degeneration (nAMD). Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving aflibercept injections every eight weeks. Nearly half (45%) of people in both studies were treated with faricimab every 16 weeks during the first year. This is the first time this level of durability has been achieved in a phase III study of an injectable eye medicine for nAMD. In both studies, faricimab was generally well-tolerated, with no new or unexpected safety signals identified.
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