OZURDEX, initially approved by the U.S.

Food and Drug Administration (FDA) in 200

9 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 corti
costeroid dexamethasone via intravitreal injection with Allergans proprietary and
innovative NOVADURsolid polymer delivery system.
Approved Uses
OZURDEX (dexamethasone intravitreal implant) is a prescription medicine that is a
n implant injected into the eye (vitreous) and used:
To treat adults with swelling of the macula (macular edema) following branch ret
inal 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
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 conjunctiv
a, including active herpes viral infection of the eye, vaccinia, varicella, myco
bacterial 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 catara
ct 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 ther
e is a hole in the back of the remaining lens capsule (called the posterior caps
ule) 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 infectio
n (endophthalmitis), eye inflammation, increased eye pressure, and retinal detac
hments. Your eye doctor may monitor you regularly after the injection.