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A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared with EU-Eylea in Subjects with Neovascular (wet) Age related Macular Degeneration (ALVOEYE)

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A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared with EU-Eylea in Subjects with Neovascular (wet) Age related Macular Degeneration (ALVOEYE)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2024

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At a glance

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

    • Most Recent Events

    • 15 Aug 2024 According to an Alvotech media release, the European Medicines Authority had accepted the EU/EEA marketing application for AVT06. The process to obtain marketing authorization could be completed in the third quarter of 2025.
    • 24 May 2024 Planned End Date changed from 1 Jan 2025 to 1 Oct 2024.
    • 03 Jan 2024 Primary endpoint (Change from baseline to Week 8 in Best-corrected Visual Acuity (BCVA)) has been met as per results presented in the Alvotech Media Release

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