Ocular Therapeutix Reports sNDA Submission of Dextenza (dexamethasone ophthalmic insert) to the US FDA for Ocular Itching

December 23, 2020 Auto Bot Clinical Trials, reports, Us FDA 0

Shots:

  • The sNDA submission is based on P-II/P-III Clinical trial assessing Dextenza(dexamethasone ophthalmic insert, 0.4mg) vs PBO for the treatment of Ocular Itching associated with allergic conjunctivitis
  • Result: At 1EPs for the pooled analysis of P-III clinical trial at Day 8; ocular itching favored DEXTENZA treated participants compared with PBO at all 3-time points: 3 min (1.85 vs 2.55), 5 min (1.90 vs 2.63), and 7 min (1.84 vs 2.61)
  • Dextenza is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the inner portion of the lower eyelid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives

Click here ­to­ read full press release/ article | Ref: Ocular Therapeutix  | Image: Ocutx

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