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A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane Versus Lucentis in Patients With Neovascular Age-Related Macular Degeneration

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Trial Profile

A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Safety of Xlucane Versus Lucentis in Patients With Neovascular Age-Related Macular Degeneration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2025

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At a glance

  • Drugs Ranibizumab (Primary)
  • Indications Choroidal neovascularisation; Wet age-related macular degeneration
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms XPLORE
  • Sponsors Xbrane

    • Most Recent Events

    • 31 Dec 2024 According to a Xbrane media release, the company has re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS (ranibizumab) to FDA (US Food and Drug Administration).
    • 08 Jul 2024 According to a Xbrane media release, company has the ambition to re-submit the BLA in the fourth quarter of 2024. Should this submission be successful, this would result in a BsUFA date during the second quarter of 2025 assuming a standard 6 month review process and ongoing alignment with the FDA, as well as successful execution of remediation plans of the manufacturing partners.
    • 21 Apr 2024 According to Xbrane media release, FDA has not requested any additional clinical trials nor any further studies to demonstrate biosimilarity. The company will request a meeting with FDA, expected to be held within 30 days from request, to clarify further requirements related to above issues and will after that announce a planned date for resubmission of the BLA.

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