Dextenza FDA Approval History
Reviewed by J.Stewart BPharm. Last updated on June 24, 2019.
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
Dextenza (dexamethasone ophthalmic insert) is a corticosteroid intracanalicular insert for the treatment of post-surgical ocular inflammation and pain.
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.
Dextenza is contraindicated in patients with active corneal, conjunctival or canalicular infections, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella; mycobacterial infections; fungal diseases of the eye, and dacryocystitis.
Warnings and Precautions
- Corticosteroids may suppress the host response and thus increase the hazard for secondary ocular infections. In acute purulent conditions, steroids may mask infection and enhance existing infection.
- Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
- Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.
- Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
- The most common ocular adverse reactions were anterior chamber inflammation including iritis and iridocyclitis (9%); intraocular pressure increased (5%); visual acuity reduced (2%); eye pain (1%); cystoid macular edema (1%); corneal edema (1%); and conjunctival hyperemia (1%).
- The most common non-ocular adverse reaction was headache (1%).
Development Timeline for Dextenza
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