Ozurdex

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Generic Name: dexamethasone intravitreal implant
Date of Approval: June 17, 2009
Company: Allergan, Inc.

Treatment for: Macular Edema

FDA Approves Ozurdex

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The United States Food and Drug Administration (FDA) has approved Ozurdex (dexamethasone intravitreal implant) 0.7 mg as the first drug therapy indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Ozurdex is a first-of-its kind therapy administered via intravitreal injection delivering dexamethasone, a highly potent corticosteroid, via Allergan's proprietary and innovative NOVADUR solid polymer delivery system. Via the NOVADUR delivery system, Ozurdex, a biodegradable implant which enables the extended release and effect of dexamethasone, is placed in the vitreous cavity in the back of the eye treating the macular edema associated with RVO, thereby improving a patient's visual acuity.

With Ozurdex, patients can achieve high concentrations of dexamethasone to reduce macular edema associated with RVO, while relying on the delivery of a consistent low level of dexamethasone to maintain edema control and enhance safety.

Indications and Usage

Ozurdex contains a corticosteroid indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

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

Ozurdex 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 keratitits), vaccinia, varicella, mycobacterial infections and fungal diseases. It is also contraindicated in patients with advanced glaucoma and in patients with known hypersensitivity to any components of this product or to other corticosteroids.

Warnings and Precautions

Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. 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. Corticosteroids should not be used in active ocular herpes simplex.

Ozurdex Side Effects

The most common ocular adverse reactions reported by greater then 2% of the patients in the first six months included increased intraocular pressure (25%), conjunctival hemorrhage (20%), eye pain (7%), conjunctival hyperemia (7%), ocular hypertension (4%), cataract (4%), and vitreous detachment (3%), and headache (3%).

Patient Counseling Information

In the days following intravitreal injection of Ozurdex, patients are at risk for potential complications including in particular, but not limited to, the development of endophthalmitis or elevated intraocular pressure. If the eye becomes red, sensitive to light, painful, or develops a change in vision, the patients should seek immediate care from an ophthalmologist.

Patients may experience temporary visual blurring after receiving an intravitreal injection. They should not drive or use machines until this has resolved.