Dexamethasone Intravitreal Implant Approved for Retinal Vein Occlusion

Yael Waknine

June 24, 2009

June 24, 2009 — On June 17, the US Food and Drug Administration (FDA) approved a dexamethasone 0.7-mg intravitreal implant (Ozurdex, Allergan, Inc) for the treatment of macular edema after branch retinal vein occlusion or central retinal vein occlusion.

Retinal vein occlusion, including branch retinal vein occlusion and central retinal vein occlusion, is the second most common retinal vascular disease after diabetic retinopathy and is a significant cause of vision loss.

"[Retinal vein occlusion] is a common condition in patients 40 years of age and older and if left untreated can lead to vision loss. In the United States alone, more than 150,000 new cases of [retinal vein occlusion] are diagnosed each year," said Mark S. Blumenkranz, MD, in a company news release. "This new therapy provides physicians with a meaningful advancement in treating [retinal vein occlusion], offering a convenient option to patients through its unique extended delivery profile."

Dr. Blumenkranz is professor and chairman of the ophthalmology department at Stanford University, Palo Alto, California

The FDA's decision was based on data from 2 multicenter, double-blind, randomized parallel studies (n = 1626). In each individual study and in pooled analysis, dexamethasone was significantly faster than placebo for achieving a 3-line (15 letters) or greater improvement in best-corrected visual acuity (P < .01), an effect that was maintained for about 1 to 3 months.

For 20% to 30% of patients, the onset of a 3-line improvement in best-corrected visual acuity occurred within the first 2 months after implantation.

Adverse events most commonly reported during the first 6 months of dexamethasone therapy included increased intraocular pressure (25% vs 1% for placebo) and conjunctival hemorrhage (7% vs 5%). Increased intraocular pressure peaked at day 60 and returned to baseline levels within 6 months; during the initial treatment period, only 0.7% of patients required laser or surgical procedures to manage this condition.

The FDA warns that intravitreal use of corticosteroids, including dexamethasone, may result in subscapular cataracts, increased intraocular pressure, glaucoma, and opportunistic ocular infections. Caution is advised when treating patients with a history of ocular herpes simplex.

Because intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments, patients should be monitored for these conditions after implantation.

Dexamethasone intravitreal implant is expected to be available in the third quarter of 2009.