A Phase III, Double-Masked, Randomized, Controlled Trial of KPI-121 in Postsurgical Inflammation

Trial Profile

A Phase III, Double-Masked, Randomized, Controlled Trial of KPI-121 in Postsurgical Inflammation

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Oct 2017

At a glance

  • Drugs Loteprednol etabonate (Primary)
  • Indications Ocular inflammation; Ocular pain
  • Focus Registrational; Therapeutic Use
  • Acronyms Hawaii-1
  • Sponsors Kala Pharmaceuticals
  • Most Recent Events

    • 25 Oct 2017 According to a Kala Pharmaceuticals media release, based on the data from this and another phase III trial, the company has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for INVELTYSTM (KPI-121 1%), a topical twice-a-day product candidate for the treatment of inflammation and pain in patients who have undergone ocular surgery.
    • 01 Apr 2015 Top-line results published in a Kala Pharmaceuticals media release.
    • 01 Apr 2015 Primary endpoint 'Resolution of Ocular Pain' at day 8 has been met, according to a Kala Pharmaceuticals media release.
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