DEXTENZA® (dexamethasone ophthalmic insert) AC

DEXTENZA is a corticosteroid indicated for:1

  • The treatment of ocular inflammation and pain following ophthalmic surgery.
  • The treatment of ocular itching associated with allergic conjunctivitis.

Please see Important Safety Information below.

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DEXTENZA offers a unique approach using a corticosteroid for the management of ocular itching associated with allergic conjunctivitis.

DEXTENZA is a resorbable, fluorescein-conjugated, preservative-free, physician-administered, hydrogel-based intracanalicular insert designed to deliver a tapered dose of dexamethasone for up to 30 days following insertion while having a documented safety profile.1,2

DEXTENZA is administered at the site of care by an eye care professional.2

DEXTENZA is benzalkonium chloride (BAK) free, and therefore, does not expose the ocular surface to preservatives.1,3

IMPORTANT SAFETY INFORMATION

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
Intraocular Pressure Increase – Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during treatment.

Bacterial Infections – 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.

Viral Infections – Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

Fungal Infections – 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.

Delayed Healing – Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

ADVERSE REACTIONS
Ocular Inflammation and Pain Following Ophthalmic Surgery
The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammation including iritis and iridocyclitis (10%), intraocular pressure increased (6%), visual acuity reduced (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia (1%). The most common non-ocular adverse reaction was headache (1%).

Itching Associated with Allergic Conjunctivitis
The most common ocular adverse reactions that occurred in patients treated with DEXTENZA were: intraocular pressure increased (3%), lacrimation increased (1%), eye discharge (1%), and visual acuity reduced (1%). The most common non-ocular adverse reaction was headache (1%).

REFERENCES: 1. Meyer J, et al. Safety of an Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis: Pooled Post Hoc Analysis of Four Studies. Presented at the Association for Research in Vision and Ophthalmology Annual Meeting; Virtual, May, 2021. 2. Ocular Therapeutics March 4, 2021 press release. https://ocutx.gcs-web.com/news-releases/news-release-details/ocular-therapeutixtm-announces-fda-acceptance-supplemental-new. Accessed March 13, 2021. 3. McLaurin EB, et al. Phase 3 randomized study of efficacy and safety of a dexamethasone intracanalicular insert in patients with allergic conjunctivitis. Am J Ophthalmol. 2021 Mar 24:S0002-9394(21)00130-6. doi: 10.1016/j.ajo.2021.03.017. Epub ahead of print. 4. Bielory L, et al. Immunol Allergy Clin North Am. 2008;28(1):43-58. 5. Zerviate (cetirizine ophthalmic solution) 0.24% [prescribing information]. Fort Worth, TX: Eyevance Pharmaceuticals, LLC; 2020. 6. Bepreve (bepotastine besilate ophthalmic solution) 1.5% [prescribing information]. Tampa, FL: Bausch + Lomb Incorporated; 2019. 7. An JA, et al. J Cataract Refract Surg. 2014;40(11):1857-1861. 8. DEXTENZA (dexamethasone ophthalmic insert) [prescribing information]. Bedford, MA: Ocular Therapeutix, Inc.; 2019.

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