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A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB15 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Neovascular Age-related Macular Degeneration

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A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB15 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Neovascular Age-related Macular Degeneration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Nov 2024

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At a glance

  • Drugs Aflibercept (Primary)
  • Indications Choroidal neovascularisation; Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Sponsors Samsung Bioepis

    • Most Recent Events

    • 18 Nov 2024 Primary endpoint has been met (Change From Baseline in Best Corrected Visual Acuity (BCVA)) , according to Samsung Bioepis media release
    • 20 Sep 2024 According to Samsung Bioepis media release, company announced that the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OPUVIZ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea2 (aflibercept), also known as SB15 on basis of this trial.
    • 07 Oct 2023 According to Samsung Bioepis media release, results of post-hoc analysis were presented at the EURETINA 2023.

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