Ocular Therapeutix Reports sNDA Submission of Dextenza (dexamethasone ophthalmic insert) to the US FDA for Ocular Itching
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
Ref: Ocular Therapeutix | Image: Ocutx
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