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Dextenza Approval Status

  • FDA approved: No
  • Brand name: Dextenza
  • Generic name: dexamethasone
  • Dosage form: Intracanalicular Depot
  • Company: Ocular Therapeutix, Inc.
  • Treatment for: Postoperative Ocular Inflammation

Dextenza (dexamethasone) is an investigational intracanalicular depot corticosteroid formulation delivering sustained release dexamethasone to the ocular surface for the treatment of post-surgical ocular inflammation and pain.

In July 2016, Ocular Therapeutix, Inc. announced the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Dextenza (dexamethasone insert) 0.4 mg, for intracanalicular use. The concerns raised by the FDA pertain to deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the manufacturing facility. The CRL did not identify any efficacy or safety concerns with respect to the clinical data provided in the NDA nor any need for additional clinical trials.

Development Status and FDA Approval Process for Dextenza

DateArticle
Nov 20, 2016Ocular Therapeutix Announces Successful Topline Results for Both Inflammation and Pain Primary Efficacy Endpoints from Phase 3 Clinical Trial of Dextenza
Jul 25, 2016Ocular Therapeutix Receives Complete Response Letter from FDA for its NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain
Dec  9, 2015Ocular Therapeutix Announces FDA Acceptance of NDA Filing for Dextenza for the Treatment of Post-Surgical Ocular Pain
Sep 28, 2015Ocular Therapeutix Submits NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain
Jun 16, 2015Ocular Therapeutix Begins Enrollment in Phase 3 Clinical Trial for Dextenza for the Treatment of Allergic Conjunctivitis

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