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A Multicenter, Randomized, Double-Masked, 3 Parallel Arms, Placebo Controlled Study to Assess the Efficacy and Safety of NOVA22007 1mg/mL (Ciclosporin/Cyclosporine) Eye Drops, Emulsion Administered in Paediatric Patients With Active Severe Vernal Keratoconjunctivitis With Severe Keratitis

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A Multicenter, Randomized, Double-Masked, 3 Parallel Arms, Placebo Controlled Study to Assess the Efficacy and Safety of NOVA22007 1mg/mL (Ciclosporin/Cyclosporine) Eye Drops, Emulsion Administered in Paediatric Patients With Active Severe Vernal Keratoconjunctivitis With Severe Keratitis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Sep 2023

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At a glance

  • Drugs Ciclosporin (Primary)
  • Indications Allergic conjunctivitis
  • Focus Registrational; Therapeutic Use
  • Acronyms VEKTIS
  • Sponsors Santen S.A.S.

    • Most Recent Events

    • 01 Aug 2023 Results of a pooled analysis from two clinical studies (NOVATIVE and VEKTIS) assessing CFS scores and safety data for the first 28 days of treatment published in the Eye
    • 24 Jun 2021 According to a Santen Pharmaceutical media release, U.S. Food and Drug Administration (FDA) has approved Verkazia™ (cyclosporine ophthalmic emulsion) 0.1% eye drops for the treatment of vernal keratoconjunctivitis (VKC) in children and adults
    • 26 Oct 2020 According to a Santen Pharmaceutical media release, Based on data from this study, the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for cyclosporine topical ophthalmic emulsion, 0.1% for the treatment of severe vernal keratoconjunctivitis (VKC) in patients ages 4-18. The FDA has set June 26, 2021 as the Prescription Drug User Fee Act (PDUFA) goal date.

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