OZURDEX^® is an implant injected into the eye (vitreous) to treat adults with macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Important Safety Information

OZURDEX^® should not be used in patients who have any infections or diseases in the eye, or surrounding eye area, including most viral diseases of the cornea and conjunctiva, including active herpes viral infection of the eye, vaccinia, varicella, mycobacterial infections, and fungal diseases.

OZURDEX^® should not be used in patients with advanced glaucoma. You should not use OZURDEX^® if you are allergic to one of its ingredients. Use of corticosteroids may produce posterior subcapsular cataracts, increased eye pressure, glaucoma, and may increase the establishment of secondary ocular infections due to bacteria, fungi, or viruses.

Injections into the vitreous in the eye are associated with serious eye infection (endophthalmitis), eye inflammation, increased eye pressure, and retinal detachments. In the days following injection with OZURDEX^®, patients are at risk for serious eye infection or elevated eye pressure. If your eye becomes red, sensitive to light, painful, or develops a change in vision, you should seek immediate care from your eye doctor. You may experience temporary visual blurring after receiving an injection and should not drive or use machines until this has resolved.

The most common side effects reported in patients include: increased eye pressure, conjunctival bleeding, eye pain, conjunctival hyperemia, ocular hypertension, cataract, vitreous detachment, and headache.

OZURDEX^® is for prescription use only. Individual results with OZURDEX^® may vary.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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