Indications and Usage
Retinal Vein Occlusion
OZURDEX® (dexamethasone intravitreal implant) is a corticosteroid indicated for the treatment
of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).
Posterior Segment Uveitis
OZURDEX® is indicated for the treatment of noninfectious uveitis affecting the posterior segment of the eye.
Dosage and Administration
FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY. The intravitreal injection procedure should be carried out under controlled
aseptic conditions. Following the intravitreal injection, patients should be monitored for elevation in intraocular
pressure and for endophthalmitis. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.
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 regularly 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.
Risk of Implant Migration: Patients in whom the posterior capsule of the lens is
absent or has a tear are at risk of implant migration into the anterior chamber.
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.
Please see full Prescribing Information. Click here.
References:
- Yau JW, Lee P, Wong TY, Best J, Jenkins A. Retinal vein occlusion: an approach to
diagnosis, systemic risk factors and management. Intern Med J. 2008;38(12):904-910.
- Royal College of Ophthalmologists. Retinal vein occlusion interim guidelines. Royal
College of Ophthalmologists website. http://www.rcophth.ac.uk/core/core_picker/download.asp?id=337&filetitle=Retinal+Vein+Occlusion+Interim+Guidelines+Feb+2009.
Accessed September 21, 2010.
- Klein R, Klein BE, Moss SE, Meuer SM. The epidemiology of retinal vein occlusion:
the Beaver Dam Eye Study. Trans Am Ophthalmol Soc.
2000;98:133-141.
- Nussenblatt RB. The natural history of uveitis. Int Ophthalmol.1990;14(5-6):303-308.
- Janigian RH Jr, Young D. Uveitis, evaluation and treatment. eMedicine website. http://emedicine.medscape.com/article/1209123-overview.
Updated November 7, 2007. Accessed September 20, 2010.
- The Merck Manuals Online Medical Library website. Uveitis: Introduction. http://www.merck.com/mmpe/sec09/ch105/ch105a.html. Accessed January 12, 2011.