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24 Jun 2019

FDA Approval of sNDA for DEXTENZA for the Treatment of Ocular Inflammation Following Ophthalmic Surgery

U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for DEXTENZA to include the treatment of ocular inflammation following ophthalmic surgery as an additional indication. With the approval of the sNDA, DEXTENZA is now approved for the treatment of both ocular inflammation and pain following ophthalmic surgery.

DEXTENZA 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. DEXTENZA 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. DEXTENZA originally received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery.

Clinical basis of approval of sNDA:

The approval of the sNDA is supported by three Phase 3 randomized, vehicle-controlled trials; patients received DEXTENZA or a vehicle immediately upon completion of cataract surgery. In all three trials, DEXTENZA had, at a statistically significant level, a higher proportion of patients than the vehicle group who were pain free on post-operative Day 8. On post-operative Day 14, in two of the three studies, DEXTENZA had a higher proportion of patients than the vehicle group, at a statistically significant level, who had an absence of anterior chamber cells.

About DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg

DEXTENZA is a corticosteroid indicated for the treatment of ocular pain following ophthalmic surgery. DEXTENZA is inserted into the lower lacrimal punctum into the canaliculus by the physician following ophthalmic surgery. A single DEXTENZA releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. DEXTENZA is preservative free, resorbable and does not require removal. Saline irrigation or manual expression can be performed to remove the insert, if necessary.

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