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Dextenza FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 14, 2021.

FDA Approved: Yes (First approved November 30, 2018)
Brand name: Dextenza
Generic name: dexamethasone
Dosage form: Ophthalmic Insert
Company: Ocular Therapeutix, Inc.
Treatment for: Postoperative Ocular Inflammation, Conjunctivitis, Allergic

Dextenza (dexamethasone ophthalmic insert) is a corticosteroid intracanalicular insert for the treatment of post-surgical ocular inflammation and pain, and ocular itching associated with allergic conjunctivitis.

  • Dextenza is inserted in the lower lacrimal punctum and into the canaliculus. A single Dextenza releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. Dextenza is resorbable and does not require removal.
  • Common adverse reactions in ophthalmic surgery patients include anterior chamber inflammation (including iritis and iridocyclitis), increased intraocular pressure, reduced visual acuity, cystoid macular edema, corneal edema, eye pain, and conjunctival hyperemia.
  • Common adverse reactions in allergic conjunctivitis patients include increased intraocular pressure, increased lacrimation, eye discharge, and reduced visual acuity.

Development Timeline for Dextenza

DateArticle
Oct 11, 2021Approval  Ocular Therapeutix Announces FDA Approval of sNDA for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for Intracanalicular Use for the Treatment of Ocular Itching Associated with Allergic Conjunctivitis
Jun 24, 2019Approval  Ocular Therapeutix Announces FDA Approval of Dextenza (dexamethasone intracanalicular insert) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
Dec  3, 2018Approval  FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery
Jun 29, 2018Ocular Therapeutix Announces NDA Resubmission of Dextenza
Jul 11, 2017Ocular Therapeutix Receives Complete Response Letter from FDA for Dextenza NDA
Feb 22, 2017Ocular Therapeutix Announces FDA Acceptance of NDA Resubmission for Dextenza for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery
Jan 23, 2017Ocular Therapeutix Resubmits NDA for Dextenza for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery
Jul 25, 2016Ocular Therapeutix Receives Complete Response Letter from FDA for its NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain
Dec  9, 2015Ocular Therapeutix Announces FDA Acceptance of NDA Filing for Dextenza for the Treatment of Post-Surgical Ocular Pain
Sep 28, 2015Ocular Therapeutix Submits NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.