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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: 27 Nov 2025

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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

  • 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.
  • 10 Jun 2025 According to an Outlook Therapeutics media release, based upon NORSE ONE, NORSE TWO and NORSE THREE trial the Scottish Medicines Consortium (SMC) announced acceptance of LYTENAVA (bevacizumab gamma) for use within NHS Scotland for the treatment of wet age-related macular degeneration (wet AMD).

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