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Roche’s faricimab hits primary endpoint in wet AMD studies 26th January 2021 Roche’s investigational bispecific antibody faricimab has hit the primary endpoint in two Phase III studies in people living with neovascular or wet age-related macular degeneration (nAMD). In the identically designed studies – TENAYA and LUCERNE – faricimab, administered via injections at fixed intervals, met the primary endpoint, showing that people receiving the treatment achieved visual acuity outcomes that were non-inferior to those receiving Regeneron’s Eylea (aflibercept) injections every eight weeks...

Roche’s faricimab hits the mark in diabetic macular edema study 21st December 2020 Faricimab targets two pathways involved in vision loss – via angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). These pathways drive vision loss by destabilising blood vessels, which results in new leaky blood vessels to form and increasing inflammation. The two identically designed phase III studies – YOSEMITE and RHINE – evaluated faricimab in people living with DME compared to Regeneron’s Eylea (aflibercept). Both studies met their primary endpoints, with faricimab given ever...

Dive Brief: Roche on Monday reported positive late-stage data for its experimental eye drug faricimab, announcing that study results showed the biologic therapy was equal to Regeneron's Eylea in treating patients with diabetic eye disease. If approved, faricimab could replace Roche's venerable drug Lucentis, which was launched in 2006 but has faced tough competition from Eylea based on dosing frequency. Lucentis has since lost patent protection, and a cheaper biosimilar from Samsung Bioepis and Biogen is now under Food and Drug Administration review. The market for biologic treatments for eye...

Logo of Swiss drugmaker Roche is seen at its headquarters in Basel ZURICH (Reuters) – Swiss drugmaker Roche said on Monday its experimental eye medicine faricimab matched Bayer and Regeneron’s Eylea against diabetic macular edema in acuity gains in two studies, including one in which patients had less-frequent shots. “More 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 study,” Roche said in a statement...

NICE recommends Novartis’ wet AMD drug Beovu 16th December 2020 The UK’s National Institute for Health and Care Excellence (NICE) has recommended Novartis’ anti-VEGF treatment Beovu (brolucizumab) for routine NHS use in wet age-related degeneration (AMD) patients. The final appraisal determination (FAD) recommendation was based on the results from Novartis’ phase III HAWK and HARRIER trials, in which Beovu met the primary endpoint. This included demonstrating improvements in best-corrected visual acuity (BCVA) from baseline that were non-inferior to Bayer’s Eylea (aflibercept) at w...