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A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery

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Trial Profile

A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jul 2024

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At a glance

  • Drugs Clobetasol (Primary)
  • Indications Ocular inflammation; Ocular pain; Postoperative inflammation; Postoperative pain
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Formosa Pharmaceuticals
  • Most Recent Events

    • 02 Jul 2024 According to a NovaBay Pharmaceuticals media release, Eyenovia acquired the U.S. commercial rights to Clobetasol from Formosa Pharmaceuticals in August 2023.
    • 04 Mar 2024 According to a Formosa Pharmaceuticals media release,the U.S. Food and Drug Administration (FDA) has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of post-operative inflammation and pain following ocular surgery.
    • 21 Sep 2023 According to an Eyenovia media release, APP13007 currently under review by the FDA and agency has assigned a Prescription Drug User Fee Act (PDUFA) action date for APP13007 of March 4, 2024.
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