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A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration

Trial Profile

A Randomized, Double Masked, Active Controlled Phase III Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-Related Macular Degeneration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Dec 2018

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At a glance

  • Drugs Aflibercept (Primary) ; Ranibizumab
  • Indications Wet age-related macular degeneration
  • Focus Registrational; Therapeutic Use
  • Acronyms VIEW-1
  • Sponsors Regeneron Pharmaceuticals
  • Most Recent Events

    • 17 Aug 2018 According to Regeneron Pharmaceuticals media release, Based on the second year data from trials (VIEW-1 and VIEW-2) U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD).
    • 13 Aug 2018 According to Regeneron Pharmaceuticals media release, Based on the second year data from trials (VIEW-1 and VIEW-2) U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for EYLEA (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The company expects to complete these discussions and receive a final FDA action within approximately two months.
    • 11 May 2018 Based on the data from SIGHT along with results from VIEW 1 and VIEW 2 studies, Eylea (aflibercept solution for injection into the eye) has been approved by the Chinese regulatory authorities for the treatment of visual impairment due to neovascular (wet) age-related macular degeneration (wAMD).
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