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A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders, NORSE THREE

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Trial Profile

A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders, NORSE THREE

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jun 2025

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At a glance

  • Drugs Bevacizumab (Primary)
  • Indications Branch retinal vein occlusion; Diabetic macular oedema; Retinal disorders; Wet age-related macular degeneration
  • Focus Adverse reactions; Proof of concept; Registrational
  • Acronyms NORSE 3; NORSE THREE
  • Sponsors Outlook Therapeutics

Most Recent Events

  • 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).
  • 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.

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