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A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration

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Trial Profile

A Clinical Effectiveness, Multicenter, Randomized, Double-masked, Controlled Study of the Efficacy and Safety of ONS-5010 in Subjects With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Dec 2023

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At a glance

  • Drugs Bevacizumab (Primary) ; Ranibizumab
  • Indications Choroidal neovascularisation; Wet age-related macular degeneration
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms NORSE 1; NORSE ONE
  • Sponsors Outlook Therapeutics

    • Most Recent Events

    • 06 Dec 2023 According to an Outlook Therapeutics media release, the formal review process of the MAA by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) is underway with an estimated decision date expected in the first half of 2024.
    • 27 Nov 2023 According to an Outlook Therapeutics media release, the company has submitted a protocol for review at an upcoming Type A meeting with the FDA in December 2023.
    • 27 Nov 2023 According to an Outlook Therapeutics media release, the company received the official minutes from the Type A meeting with the U.S. Food and Drug Administration (FDA) held in October 2023 regarding the Complete Response Letter (CRL) dated August 29, 2023 for the Biologics License Application (BLA) for ONS-5010.
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