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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: 05 Dec 2024

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At a glance

  • Drugs Bevacizumab (Primary) ; Ranibizumab
  • Indications Choroidal neovascularisation; Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms NORSE 2; NORSE TWO
  • Sponsors Outlook Therapeutics

    • Most Recent Events

    • 04 Dec 2024 According to an Outlook Therapeutics media release, company announced that the National Institute for Health and Care Excellence (NICE) has recommended LYTENAVA (bevacizumab gamma), as an option for the treatment of wet AMD. The positive NICE recommendation was based on results from Outlook Therapeutics wet AMD clinical program for ONS-5010 / LYTENAVA, which consists of three completed registration clinical trials - NORSE ONE, NORSE TWO and NORSE THREE.
    • 08 Jul 2024 According to an Outlook Therapeutics media release, the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for LYTENAVA™ (bevacizumab gamma), an ophthalmic formulation of bevacizumab for the treatment of wet AMD in the UK. LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK
    • 28 May 2024 According to an Outlook Therapeutics media release, today announced the European Commission has granted Marketing Authorization for LYTENAVA (bevacizumab gamma), mixed application grounded on Article 8.3 of Directive 2001/83/EC, for the treatment of wet AMD in the EU, is based on the results from three wet AMD clinical program (NORSE ONE, NORSE TWO and NORSE THREE).

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