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Faricimab meets primary endpoint and shows strong durability across two phase III Studies, YOSEMITE and RHINE, for Diabetic Macular Edema.- Genentech/Roche

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Published:22nd Dec 2020
Genentech, a member of the Roche Group 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 personalized 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 randomized to receive either faricimab or aflibercept at fixed eight-week intervals, or faricimab at personalized intervals of up to 16 weeks, following a loading phase. In a secondary endpoint, across both studies, more than half of participants in the faricimab personalized dosing arms achieved an extended time between treatments of 16 weeks at year one. This is the first time any investigational medicine has achieved this level of durability in a Phase III study of people with DME. In the United States, an estimated 750,000 people are living with DME, a leading cause of vision loss among working-age adults. While anti-vascular endothelial growth factor (VEGF) monotherapy injections have significantly reduced vision loss from DME, the treatment burden associated with frequent eye injections and physician visits can lead to under-treatment and, potentially, less than optimal vision outcomes. It has been almost a decade since a medicine with a new mechanism of action has been approved to treat DME. Faricimab is the first investigational bispecific antibody designed for the eye. It targets two distinct pathways – via angiopoietin-2 (Ang-2) and VEGF-A – that drive a number of retinal conditions, including DME. In addition to the YOSEMITE and RHINE studies, the Phase III Rhone-X study is investigating the long-term safety and tolerability of faricimab for the treatment of DME. Faricimab is also being studied in the Phase III TENAYA and LUCERNE studies as a potential treatment for neovascular or “wet” age-related macular degeneration (nAMD), an advanced form of AMD, which can cause rapid, severe and irreversible vision loss. Detailed results from the YOSEMITE and RHINE studies will be presented in February at Angiogenesis, Exudation, and Degeneration 2021 , a medical symposium presented by Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine and submitted for approval for the treatment of DME around the world.
Condition: Diabetic Macular Oedema
Type: drug

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