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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2019

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At a glance

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

    • 23 Aug 2018 The U.S. Food and Drug Administration (FDA) has approved INVELTYSTM (loteprednol etabonate ophthalmic suspension) 1% for the treatment of post-operative inflammation and pain following ocular surgery, according to a Kala Pharmaceuticals media release.
    • 05 Jan 2018 According to a Kala Pharmaceuticals media release, the US FDA has accepted New Drug Application (NDA) for INVELTYSTM (KPI-121 1%),for the treatment of inflammation and pain in patients who have undergone ocular surgery, for review and has set a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018.
    • 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.
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