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A Phase 3 Randomized, Double-masked, Multicenter Study to Compare the Efficacy and Safety of the Proposed Aflibercept FYB203 Biosimilar in Comparison to Eylea in Patients With Neovascular Age-Related Macular Degeneration

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Trial Profile

A Phase 3 Randomized, Double-masked, Multicenter Study to Compare the Efficacy and Safety of the Proposed Aflibercept FYB203 Biosimilar in Comparison to Eylea in Patients With Neovascular Age-Related Macular Degeneration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2025

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At a glance

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

    • Most Recent Events

    • 25 Feb 2025 According to a Formycon media release, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB203 (aflibercept), a biosimilar to Eylea, under the brand name AHZANTIVE. The approval covers the treatment of Age-Related Neovascular (wet) Macular Degeneration and other serious retinal conditions, including Diabetic Macular Edema, visual impairment due to Myopic Choroidal Neovascularisation and Macular Edema following Retinal Vein Occlusion .
    • 20 Jan 2025 According to a Formycon media release,company announced the European Commission has granted central marketing authorization for FYB203 (Aflibercept).The decision of the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency from November 2024 and applies to all countries in the European Economic Area, including the 27 member states of the European Union as well as Iceland Liechtenstein, and Norway.
    • 13 Jan 2025 According to a Formycon media release, the European Commission's decision on approval is expected in the second half of January 2025.

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