Absence of anterior chamber cells

Absence of anterior chamber cells^1-3

In three Phase 3 clinical trials (Study 1: DEXTENZA n=164, Placebo n=83, Study 2: DEXTENZA n=161, Placebo n=80, Study 3: DEXTENZA n=216, Placebo n=222) a statistically significant greater proportion of patients receiving the dexamethasone insert had an absence of anterior chamber cells at Day 14 in Study 1 and 3; this difference was not statistically significant in Study 2 (Study 1: 33% versus 14%, P= 0.0018, Study 2: 39% versus 31%, P=0.2182, Study 3: 52% versus 31%, P<0.0001).

References: 1. DEXTENZA [package insert]. Bedford, MA: Ocular Therapeutix, Inc: 2021. 2. Walters T, et al. J Clin Exp Ophthalmol. 2016;7(4): 1-11. 3. Tyson S, et al. J Cataract Refract Surg. 2019; 45(2):204–212 [erratum in: 2019;45(6):895]

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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.

Other Potential Corticosteroid Complications – The initial prescription and renewal of medication order of DEXTENZA should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated.

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%).

INDICATIONS

DEXTENZA is a corticosteroid indicated for:

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

Please see full Prescribing Information.

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