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A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease

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Trial Profile

A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2023

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At a glance

  • Drugs Loteprednol etabonate (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms STRIDE 1
  • Sponsors KALA BIO; Kala Pharmaceuticals

    • Most Recent Events

    • 02 Aug 2023 According to a Kala Pharamceuticals media release, Kala Pharamceuticals has changed its name to KALA BIO.
    • 27 Oct 2020 According to an Kala Pharmaceuticals media release U.S. Food and Drug Administration (FDA) has approved EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.The FDA granted approval to EYSUVIS based on results from four clinical trials, including three Phase 3 trials and one Phase 2 trial.
    • 26 May 2020 According to an Kala Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) resubmission for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term treatment of the signs and symptoms of dry eye disease and the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2020.

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