HANDLING OF DEXTENZA

HANDLING THE INSERT1

Carefully remove the foam carrier from the foil pouch and transfer to a clean and dry area.

Dry insert dimensions2

~0.55mm in diameter and 3mm in length.

INSERTING INTO THE CANALICULUS

Showing a graphic of the surgeon pulling lid temporally

PULL the lid temporally to open the angle of the canaliculus.3

Showing a dilator being used to dilate the punctum prior to insertion

DILATE the punctum thoroughly for both depth and diameter with an ophthalmic dilator. Avoid perforating the canaliculus. If perforation occurs, do not insert DEXTENZA.1,3

Showing a graphic of the surgeon drying the punctal area

DRY the punctal area. DEXTENZA hydrates quickly upon contact with moisture. If DEXTENZA begins to hydrate before fully inserted, discard the product and use a new DEXTENZA.1

Showing the surgeon using forceps to insert the DEXTENZA insert into the canaliculus

INSERT DEXTENZA nasally using blunt (non-toothed) forceps into the canaliculus until the distal end is just below the punctal opening. Excessive squeezing of DEXTENZA may cause deformation.1,3

Physicians rated DEXTENZA as easy-to-insert4,5*

*73.6% of physicians in Study 1, 76.4% in Study 2, and 79.6% in Study 3, for treatment of ocular inflammation and pain following opthalmic surgery, rated DEXTENZA as easy-to-insert4,5

ONCE INSERTED1

DEXTENZA can be visualized by a blue light source (eg, slit lamp or hand-held blue light) with a yellow filter.

STORAGE AND HANDLING

How DEXTENZA is supplied

DEXTENZA is supplied sterile in a foam carrier within a foil laminate pouch:

  • NDC 70382-204-10 Carton containing 10 pouches (10 inserts)
  • NDC 70382-204-01 Carton containing 1 pouch (1 insert)

Proper storage and handling

  • Do not freeze. Store refrigerated, between 2°C and 8°C (36°F and 46°F).
  • Protect from light, keep in package until use.
  • Do not use if pouch has been damaged or broken.
  • DEXTENZA is intended for single dose only.
Dextenza Packaging

References: 1. DEXTENZA [package insert]. Bedford, MA: Ocular Therapeutix, Inc; 2021. 2. Data on File 00575. Ocular Therapeutix, Inc. 3. Data on File 00846. Ocular Therapeutix, Inc. 4. Walters T, et al. J Clin Exp Opthalmol. 2016;7(4):1-11. 5. Tyson SL, 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.