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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 Macular Edema Secondary to Branch Retinal Vein Occlusion

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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 Macular Edema Secondary to Branch Retinal Vein Occlusion

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2024

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At a glance

  • Drugs Faricimab (Primary) ; Aflibercept
  • Indications Branch retinal vein occlusion; Retinal oedema
  • Focus Registrational; Therapeutic Use
  • Acronyms BALATON
  • Sponsors Roche

    • Most Recent Events

    • 30 Jul 2024 According to a Roche media release, the European Commission (EC) has approved Vabysmo (faricimab) for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO, branch RVO or central RVO), based on positive results from two global Phase III BALATON and COMINO studies, which evaluated Vabysmo in more than 1,200 people with macular edema due to BRVO and CRVO.
    • 29 Jul 2024 According to Hoffmann-La Roche Limited media release, based on results from two clinical studies (BALATON and COMINO), Health Canada has authorized Vabysmo (faricimab injection) for the treatment of macular edema secondary to retinal vein occlusion (RVO).
    • 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).

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