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Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration

Trial Profile

Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients With Neovascular Age-related Macular Degeneration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jun 2020

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At a glance

  • Drugs Abicipar pegol (Primary) ; Ranibizumab
  • Indications Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms SEQUOIA
  • Sponsors Allergan
  • Most Recent Events

    • 25 Jun 2020 According to an Allergan media release, the letter from the FDA indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of neovascular (wet) age-related macular degeneration (AMD). AbbVie plans to meet with the FDA to discuss their comments and determine next steps.
    • 25 Jun 2020 According to an Allergan media release, based on CEDAR and SEQUOIA trials, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application (BLA) for Abicipar pegol for patients with neovascular (wet) age-related macular degeneration (nAMD).
    • 11 Oct 2019 Results presented in an Allergan Media Release.
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