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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: 08 Oct 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

    • 02 Oct 2024 According to a Novaliq media release, European Commission has approved Vevizye (ciclosporin 0.1% eye drops solution) in all 27 EU member states. Additional regulatory applications are under review in several countries, including China, Australia, and New Zealand.
    • 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.

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