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Ocular Therapeutix announces FDA approval of sNDA for Dextanza.

Ocular Therapeutix announced the FDA approved a Supplemental New Drug Application, or sNDA, for Dextanza to include the treatment of ocular inflammation following ophthalmic surgery as an additional indication. With the approval of the sNDA, Dextanza is now approved for the treatment of both ocular inflammation and pain following ophthalmic surgery. "Dextanza is the first FDA-approved intracanalicular insert, a novel route of administration that delivers drug to the surface of the eye without the need for eye drops. Dextanza is a preservative-free, resorbable hydrogel insert that delivers 0.4mg of dexamethasone to treat post-surgical ocular inflammation and pain for up to 30 days with a single administration. Dextanza originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery."

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Publication:The Fly
Date:Jun 21, 2019
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