Dexamethasone insert recommended

August 3, 2011

The National Institute for Health and Clinical Excellence (NICE), an independent advisory organization in England, has recommended use of a 0.7-mg dexamethasone intravitreal implant in an applicator (Ozudex, Allergan) for the treatment of macular edema due to central retinal vein occlusion (CRVO) as well as for branch retinal vein occlusion (BRVO) in cases in which laser photocoagulation is neither beneficial nor appropriate.

London-The National Institute for Health and Clinical Excellence (NICE), an independent advisory organization in England, has recommended use of a 0.7-mg dexamethasone intravitreal implant in an applicator (Ozudex, Allergan) for the treatment of macular edema due to central retinal vein occlusion (CRVO), as well as for branch retinal vein occlusion (BRVO) in cases in which laser photocoagulation is neither beneficial nor appropriate.

The biodegradable implant with its single-use applicator is designed to release the corticosteroid slowly into the eye so that it can act locally to control edema, reduce inflammation around the occlusion, and improve vision. Benefits of a single injection can last for up to 6 months, according to research.

“RVO is the second most common cause of reduced vision due to retinal vascular disease. The decision . . . represents the first NICE recommendation for a licensed treatment for macular edema associated with RVO and, with it, NICE has made available to retinal specialists and their patients an important treatment for this potentially devastating condition,” said Douglas D. Ingram, executive vice president, president, Allergan, Europe, Africa, and the Middle East. “We look forward to working with retinal specialists, hospitals, and commissioning groups in the United Kingdom to support the National Health Service in rapidly adopting this cost-effective solution to maximize patient benefits and to minimize premature vision loss as a result of RVO.”

The efficacy of the dexamethasone implant was assessed in two 6-month, prospective, double-masked, parallel-group studies in which 1,267 patients with macular edema due to either BRVO or CRVO were randomly assigned to be treated by either the implant or a sham (placebo) procedure. Clinically significant improvement in vision, defined as ≥15 letters or 3 lines on an eye chart, was seen after 2 months in up to 30% of patients with macular edema due to RVO following just one injection of dexamethasone, according to the company. In some patients, this improvement was maintained for up to 6 months. Up to 80% of patients had an improvement or no worsening in vision (defined as >0 letters on an eye chart) over the 6 months. The most frequently reported adverse reactions in patients who received dexamethasone were increased IOP (24.0%) and conjunctival hemorrhage (14.7%).

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