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Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

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Trial Profile

Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Dec 2020

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At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Ocular inflammation; Ocular pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Ocular Therapeutix

Most Recent Events

  • 22 Dec 2020 Pooled analysis of three phase III trials published in the Ocular Therapeutix Media Release.
  • 25 Jun 2020 Results assessing the pharmacology, efficacy and tolerability of the dexamethasone intracanalicular insert for the treatment of post-surgical ocular pain and inflammation published in the Drugs
  • 21 Jun 2019 According to an Ocular Therapeutix media release, the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for DEXTENZA to include the treatment of ocular inflammation following ophthalmic surgery as an additional indication. The approval of the sNDA is supported by three Phase 3 randomized trials.

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