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A 52-week Multicenter, Randomized, Double-masked, 2-arm Parallel Study to Compare Efficacy, Safety and Immunogenicity of SOK583A1 to Eylea, Administered Intravitreally, in Patients With Neovascular Age-related Macular Degeneration

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Trial Profile

A 52-week Multicenter, Randomized, Double-masked, 2-arm Parallel Study to Compare Efficacy, Safety and Immunogenicity of SOK583A1 to Eylea, Administered Intravitreally, in Patients With Neovascular Age-related Macular Degeneration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Nov 2024

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At a glance

  • Drugs Aflibercept (Primary)
  • Indications Wet age-related macular degeneration
  • Focus First in man; Registrational; Therapeutic Use
  • Acronyms MYLIGHT
  • Sponsors HEXAL; Sandoz

Most Recent Events

  • 15 Nov 2024 According to a Sandoz media release, company announced that the European Commission (EC) has granted marketing authorization for Afqlir (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection, to treat various retinal diseases, including neovascular age-related macular degeneration (nAMD).
  • 01 Oct 2024 Results published in the Retina
  • 12 Aug 2024 According to a Sandoz media release, the US Food and Drug Administration (FDA) has approved Enzeevu™ (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD). The FDA granted approval based on the totality of evidence, including comprehensive analytical and preclinical in vitro study data, as well as clinical data from the Mylight study.

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