OZURDEX® (dexamethasone intravitreal implant) 0.7 mg
OZURDEX®, initially approved by the U.S. Food and Drug Administration (FDA) in 2009 as the first drug therapy for the treatment of macular edema following retinal vein occlusion (RVO), received FDA approval for the treatment of non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye in 2010.
OZURDEX® is a biodegradable implant that delivers an extended release of the corticosteroid dexamethasone via intravitreal injection with Allergan’s proprietary and innovative NOVADUR® solid polymer delivery system.
Approved Uses
OZURDEX® (dexamethasone intravitreal implant) is a prescription medicine that is an implant injected into the eye (vitreous) and used:
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To treat adults with swelling of the macula (macular edema) following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
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To treat adults with noninfectious inflammation of the uvea (uveitis) affecting the back segment of the eye
IMPORTANT SAFETY INFORMATION
OZURDEX® should not be used if you 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 if you have advanced glaucoma.
If you have had cataract surgery and your eye doctor did not replace your cataract with an artificial lens AND there is a hole in the back of the remaining lens capsule (called the posterior capsule) in the back of your eye, you should not use OZURDEX®.
If you have had cataract surgery and your eye doctor replaced your cataract with an artificial lens in front of the colored part of your eye (the iris) AND there is a hole in the back of the remaining lens capsule (called the posterior capsule) in the back of your eye, you should not use OZURDEX®.
You should not use OZURDEX® if you are allergic to any of its ingredients.
Injections into the vitreous in the eye are associated with serious eye infection (endophthalmitis), eye inflammation, increased eye pressure, and retinal detachments. Your eye doctor may monitor you regularly after the injection.
Use of corticosteroids may produce posterior subcapsular cataracts, increased eye pressure, glaucoma, and may increase the establishment of secondary eye infections due to bacteria, fungi, or viruses.
There may be a risk of the implant moving into the front chamber of the eye if you had the posterior capsule of the lens removed or if you have a tear in the capsule.
The most common side effects reported in patients include: increased eye pressure, conjunctival bleeding, eye pain, eye redness, ocular hypertension, cataract, vitreous detachment, and headache.
In the days following injection with OZURDEX®, you may be at risk for potential complications including in particular, but not limited to, the development of serious eye infection or increased 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 machinery until your vision has resolved.
APC37AV12