Dexamethasone punctal plug - Ocular Therapeutix

Drug Profile

Dexamethasone punctal plug - Ocular Therapeutix

Alternative Names: Dexamethasone intracanalicular plug; Dexamethasone punctum plug; Dextenza; OTX-DP

Latest Information Update: 18 Jul 2017

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At a glance

  • Originator Ocular Therapeutix
  • Class Anti-inflammatories; Antiemetics; Antineoplastics; Fluorinated steroids; Glucocorticoids; Pregnadienetriols; Small molecules
  • Mechanism of Action Glucocorticoid receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No

Highest Development Phases

  • Preregistration Ocular pain
  • Phase III Allergic conjunctivitis; Ocular inflammation
  • Phase II Dry eyes

Most Recent Events

  • 12 Jul 2017 US FDA denies NDA of dexamethasone punctal plug for treatment of Ocular pain in USA
  • 11 Jul 2017 Ocular Therapeutics receives complete response letter from the FDA for Dexamethasone punctal plug in Ocular pain
  • 10 Jul 2017 Ocular Therapeutics submits an amendment to the NDA resubmission for dexamethasone punctal plug to the US FDA and requests extension of PDUFA date by three months
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