DEXTENZA is now approved for the treatment of ocular itching associated with allergic conjunctivitis.

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

Preservatives (eg, benzalkonium chloride) in some topical drops can cause changes in the ocular surface, which may lead to inflammation and damage to the tear film.4

Demonstrated Efficacy and Safety Profile in treatment of ocular itching due to allergic conjunctivitis can be found in the full Prescribing Information.

THREE PIVOTAL PHASE 3 STUDIES IN 255 PATIENTS1

Study Design

Randomized, Double-masked, Vehicle-controlled Studies in Allergic Conjunctivitis Patients.

Objective

To evaluate the safety and efficacy of DEXTENZA for the treatment of signs and symptoms of allergic conjunctivitis.

Primary Endpoint

Ocular itching reported by the patient at 3, 5 and 7 minutes post-conjunctival allergen challenge on Day 8.*

* Scores for subject-reported ocular itching using a 0 [none] – 4 [severe] scale

In all three studies, DEXTENZA resulted in lower mean ocular itching scores compared with the placebo group at all time points throughout the one-month duration of the study.

In two of the three studies, a higher proportion of patients had statistically significant reduction in ocular itching on Day 8, at 3 minutes, 5 minutes and 7 minutes post-challenge in the DEXTENZA group than in the placebo group. Results are shown below.

† Placebo was an insert containing no drug
‡ CI = Confidence Interval
§ In Study 2, DEXTENZA did not meet the primary endpoint for reduction in ocular itching in Day 8

DEXTENZA was well tolerated1

Most common ocular adverse reactions in DEXTENZA patients (≥1%)

Data pooled from one Phase 2 and three Phase 3 clinical studies

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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.