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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. In 2014, the FDA approved OZURDEX® as the first corticosteroid indicated for the treatment of diabetic macular edema (DME) in adult patients who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic).

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:

  • To treat adults with swelling of the macula (macular edema) following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
  • To treat adults with noninfectious inflammation of the uvea (uveitis) affecting the back segment of the eye
  • To treat adults with diabetic macular edema who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic).

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.

OZURDEX® should not be used if you have a posterior lens capsule that is not intact.

You should not use OZURDEX® if you are allergic to any of its ingredients.

Injections into the vitreous in the eye, including those with OZURDEX®, 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. Let your doctor know if you have a history of ocular herpes simplex.

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 for retinal vein occlusion and uveitis include: increased eye pressure, conjunctival blood spot, eye pain, eye redness, ocular hypertension, cataract, vitreous detachment, and headache.

The most common side effects reported in patients with diabetic macular edema include: cataract, increased eye pressure, conjunctival blood spot, reduced vision, inflammation of the conjunctiva, specks that float in the field of vision, swelling of the conjunctiva, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, inflammation of the cornea, anterior chamber inflammation, retinal tear, drooping eyelid and high blood pressure.

After repeated injections with OZURDEX®, a cataract may occur. If this occurs, your vision will decrease and you will need an operation to remove the cataract and restore your vision. You may develop increased eye pressure with OZURDEX® that will need to be managed with eye drops, and, rarely, with surgery.

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.

Please See Full OZURDEX® Product Information (PDF) 
OZURDEX® Web Site 


APC47CQ14