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A Phase 3, Multi-center, Randomized, Double-masked, Vehicle-controlled Clinical Trial to Assess the Efficacy and Safety of Topical CyclASol for the Treatment of Dry Eye Disease

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Trial Profile

A Phase 3, Multi-center, Randomized, Double-masked, Vehicle-controlled Clinical Trial to Assess the Efficacy and Safety of Topical CyclASol for the Treatment of Dry Eye Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jun 2024

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At a glance

  • Drugs Ciclosporin (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms ESSENCE 2; ESSENCE-2 OLE
  • Sponsors Novaliq

    • Most Recent Events

    • 05 Jun 2024 Results (from open-label extension study) presented in the Novaliq Media Release.
    • 08 Jun 2023 According to a Novaliq media release, the U.S. Food and Drug Administration (FDA) has approved VEVYE™ (cyclosporine ophthalmic solution) 0.1% for the treatment of the signs and symptoms of dry eye disease.
    • 02 May 2023 According to a Novaliq media release, 12-month data from this trial and data from pooled analysis from ESSENCE-1 and ESSENCE-2 will be presented during the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting 2023.

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