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A Randomized Double-Masked Study to Compare the Ocular Safety,Tolerability,and Efficacy of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

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Trial Profile

A Randomized Double-Masked Study to Compare the Ocular Safety,Tolerability,and Efficacy of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Nov 2021

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At a glance

  • Drugs Bromfenac (Primary)
  • Indications Ocular inflammation; Ocular pain; Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors InSite Vision; Sun Pharma Global FZE; Sun Pharmaceutical Industries
  • Most Recent Events

    • 09 Apr 2016 According to Sun Pharmaceutical Industries media release, the US FDA has approved a New Drug Application (NDA) for BromSite for the treatment of inflammation and prevention of pain in cataract surgery.
    • 17 Aug 2015 According to InSite Vision media release, the US FDA has accepted for review a New Drug Application (NDA) for BromSite for the treatment of inflammation and prevention of pain in cataract surgery.
    • 11 Jun 2015 According to InSite Vision media release, the company has completed the submission of New Drug Application (NDA) to the US FDA for the treatment of inflammation and prevention of pain in cataract surgery.
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