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 uveitis, affecting the posterior segment of the eye in 2010.
OZURDEX® is a biodegradable implant that delivers the corticosteroid dexamethasone via intravitreal injection with Allergan’s proprietary NOVADUR® solid polymer delivery system.
Important Safety Information
Contraindications
Ocular or Periocular Infections
OZURDEX® (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
Advanced Glaucoma
OZURDEX® is contraindicated in patients with advanced glaucoma.
Hypersensitivity
OZURDEX® is contraindicated in patients with known hypersensitivity to any components of this product.
Warnings and Precautions
Intravitreal Injection-related Effects
Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the injection.
Potential Steroid-related Effects
Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses.
Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex.
Adverse Reactions
The most common ocular adverse reactions reported by greater than 2% of patients in the first 6 months following injection of OZURDEX® for retinal vein occlusion and posterior segment uveitis include: intraocular pressure increased (25%), conjunctival hemorrhage (22%), eye pain (8%), conjunctival hyperemia (7%), ocular hypertension (5%), cataract (5%), vitreous detachment (2%), and headache (4%).
Increased IOP with OZURDEX® peaked at approximately week 8. During the initial treatment period, 1% (3/421) of the patients who received OZURDEX® required surgical procedures for management of elevated IOP.