Indications and Usage
Retinal Vein Occlusion
OZURDEX^® (dexamethasone intravitreal implant) is a corticosteroid indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Posterior Segment Uveitis
OZURDEX^® is indicated for the treatment of noninfectious uveitis affecting the posterior segment of the eye.

Dosage and Administration
FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY. The intravitreal injection procedure should be carried out under controlled aseptic conditions. Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.

Important Safety Information
Contraindications
Ocular or Periocular Infections: OZURDEX^® (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.

Advanced Glaucoma: OZURDEX^® is contraindicated in patients with advanced glaucoma.

Hypersensitivity: OZURDEX^® is contraindicated in patients with known hypersensitivity to any components of this product.

Warnings and Precautions
Intravitreal Injection-related Effects: Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored regularly following the injection.

Potential Steroid-related Effects: Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.

Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex.

Risk of Implant Migration: Patients in whom the posterior capsule of the lens is absent or has a tear are at risk of implant migration into the anterior chamber.

Adverse Reactions
The most common ocular adverse reactions reported by greater than 2% of patients in the first 6 months following injection of OZURDEX^® for retinal vein occlusion and posterior segment uveitis include: intraocular pressure increased (25%), conjunctival hemorrhage (22%), eye pain (8%), conjunctival hyperemia (7%), ocular hypertension (5%), cataract (5%), vitreous detachment (2%), and headache (4%).

Increased IOP with OZURDEX^® peaked at approximately week 8. During the initial treatment period, 1% (3/421) of the patients who received OZURDEX^® required surgical procedures for management of elevated IOP.

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