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A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (TENAYA)

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Trial Profile

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (TENAYA)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2025

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At a glance

  • Drugs Faricimab (Primary) ; Aflibercept
  • Indications Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms TENAYA
  • Sponsors Roche

Most Recent Events

  • 01 Aug 2024 Results reporting 2-year data from Japan subgroup of phase III TENAYA trial published in the Graefes Archive for Clinical and Experimental Ophthalmology
  • 04 Jul 2024 According to a Genentech media release, company announced that the U.S. Food and Drug Administration (FDA) has approved the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).
  • 01 May 2023 Results of subgroup analysis (n=133) assessing 1-year efficacy, durability, and safety of faricimab versus aflibercept in patients with neovascular age-related macular degeneration (nAMD) enrolled in the Japan subgroup published in the Japanese Journal of Ophthalmology

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