Roche Prepares Faricimab For Filing After Phase III AMD Data

Non-Inferior To Eylea With Longer Dosing Intervals

Top-line Phase III data for faricimab in age-related macular degeneration leave Roche poised to file the bi-specific antibody for retinal diseases, but again there is no advantage with the novel dual-acting product over Eylea.    

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Topline data from two Phase III trials in neovascular or ‘wet’ age-related macular degeneration (nAMD) show Roche Holding AG’s investigational bispecific antibody faricimab is as effective as – but no better than – Bayer AG and Regeneron Pharmaceuticals, Inc.’s Eylea when dosed at fixed intervals of up to every 16 weeks.

The data from the identical TENAYA and LUCERNE studies add to those already reported from two Phase III trials in diabetic macular edema – YOSEMITE and RHINE – just before Christmas

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