Ocular Therapeutix announces submission to the FDA of a supplemental new drug application for Dextenza (dexamethasone ophthalmic insert) for the treatment of ocular itching associated with allergic conjunctivitis

Ocular Therapeutix

22 December 2020 - PDUFA target action date anticipated for October 2021.

Ocular Therapeutix today announced the submission of the supplemental new drug application to the U.S. FDA for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use. 

If approved, this application would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of Dextenza.

Read Ocular Therapeutix press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier