ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.
Important Safety Information
Do not use ILUVIEN if you have or think you might have an infection in or around the eye.
ILUVIEN should not be used if you have advanced glaucoma.
You should not use ILUVIEN if you are allergic to any ingredients of ILUVIEN.
Injections into the vitreous in the eye are associated with a serious eye infection
(endophthalmitis), eye inflammation, increased eye pressure, glaucoma, and retinal detachments. Your
eye doctor should monitor you regularly after the injection.
Use of corticosteroids including ILUVIEN may produce cataracts (ILUVIEN 82%; sham 50%), increased
eye pressure (ILUVIEN 34%; sham 10%), glaucoma, and may increase secondary eye infections due to
bacteria, fungi, or viruses. Let your doctor know if you have a history of herpes viral infections of
If the posterior capsule of the lens of your eye is missing or torn the ILUVIEN implant may move to
the front chamber of the eye.
The most common side effects reported in patients with diabetic macular edema who were treated with
ILUVIEN include cataracts (ILUVIEN 82%; sham 50%) and increased eye pressure (ILUVIEN 34%; sham 10%).
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.