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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: 19 Feb 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

  • 11 Feb 2026 According to an Outlook Therapeutics media release, company announced that it has submitted a Type A meeting request to the U.S. Food and Drug Administration (FDA) following receipt of a Complete Response Letter (CRL) dated December 30, 2025, regarding the Companys Biologics License Application (BLA) for ONS-5010/LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).
  • 03 Nov 2025 According to an Outlook Therapeutics media release, company announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, after receiving the official minutes from the FDA Type A meeting conducted in September 2025.
  • 29 Sep 2025 According to an Outlook Therapeutics media release, the company completed the Type A Meeting with the U.S. Food and Drug Administration (FDA) to discuss the complete response letter (CRL) dated August 27, 2025 regarding the biologics license application (BLA) resubmission for ONS-5010 and to resubmit its BLA before the end of calendar year 2025, after reviewing the agency feedback and meeting minutes.

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