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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 Aug 2026

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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

  • 25 Jul 2026 According to an Outlook Therapeutics media release, the U.S. Food and Drug Administration (FDA) has approved LYTENAVA (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD), commonly known as wet AMD.
  • 16 Jun 2026 According to an Outlook Therapeutics media release, FDA accepted the resubmission of the Biologics License Application (BLA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD), or wet AMD. The Company has been informed that the resubmission is a Class 1 review, with a PDUFA target action date of July 29, 2026.
  • 01 Jun 2026 According to an Outlook Therapeutics media release, company announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010/LYTENAVA for the treatment of neovascular age-related macular degeneration (nAMD).

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