Dextenza Approval History

Reviewed by J.Stewart BPharm. Last updated on Dec 17, 2018.

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.

Contraindications
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.

Adverse Reactions

• 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 History and FDA Approval Process for Dextenza

Date	Article
Dec  3, 2018	FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery
Jun 29, 2018	Ocular Therapeutix Announces NDA Resubmission of Dextenza
Jul 11, 2017	Ocular Therapeutix Receives Complete Response Letter from FDA for Dextenza NDA
Feb 22, 2017	Ocular Therapeutix Announces FDA Acceptance of NDA Resubmission for Dextenza for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery
Jan 23, 2017	Ocular Therapeutix Resubmits NDA for Dextenza for the Treatment of Ocular Pain Occurring After Ophthalmic Surgery
Nov 20, 2016	Ocular Therapeutix Announces Successful Topline Results for Both Inflammation and Pain Primary Efficacy Endpoints from Phase 3 Clinical Trial of Dextenza
Jul 25, 2016	Ocular Therapeutix Receives Complete Response Letter from FDA for its NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain
Dec  9, 2015	Ocular Therapeutix Announces FDA Acceptance of NDA Filing for Dextenza for the Treatment of Post-Surgical Ocular Pain
Sep 28, 2015	Ocular Therapeutix Submits NDA for Dextenza for the Treatment of Post-Surgical Ocular Pain
Jun 16, 2015	Ocular Therapeutix Begins Enrollment in Phase 3 Clinical Trial for Dextenza for the Treatment of Allergic Conjunctivitis

Further information

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