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
Further information
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