DEXTENZA ELUTYX™ TECHNOLOGY

View of animated hydrogel matrix. DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use, uses ELUTYX™ Technology. Diagram identifies PEG*, Trilysine, and Hydrolyzable Linkages. DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use. 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. 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. Animated view of eye with DEXTENZA being inserted into the punctum using forceps. Activates with moisture and swells to fit securely in the canaliculus. Zooms in to animated view of hydrogel matrix with dexamethasone. Releases dexamethasone for up to 30 days. Zooms out to view of blinking eye and DEXTENZA releasing drug. Dexamethasone bathes the ocular surface. Zooms in to view of DEXTENZA in punctum as it is disintegrating. Resorbs slowly through the course of treatment and clears via the nasolacrimal duct. Arrows show the direction of DEXTENZA as it clears through the nasolacrimal duct.

 
*PEG = Polyethylene Glycol
ELUTYX Technology does not contain PEGylated components.
 

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%).
 
© 2023 Ocular Therapeutix, Inc. All rights reserved. DEXTENZA is a registered trademark of Ocular Therapeutix, Inc. PP-US-DX-0207-V4