FDA approves sBLA for Dextenza to include the treatment of ocular inflammation following ophthalmic surgery

Ocular Therapeutix, Inc. announced the 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 treatmen t of ocular pain following ophthalmic surgery.

The approval of the sNDA is supported by three Phase III randomized, vehicle-controlled trials; patients received Dextrenza 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.