Dexamethasone implant approved for use against macular edema in Scotland

Glasgow, Scotland-The Scottish Medicines Consortium (SMC) has accepted for use a dexamethasone 700 µg intravitreal implant (Ozurdex, Allergan) in the National Health Service. The implant is for use in adult patients with macular edema following central retinal vein occlusion (CRVO) and in patients with branch retinal vein occlusion (BRVO) whose conditions are not clinically suitable for laser treatment. The latter group includes patients with dense macular hemorrhage and patients in whom previous laser treatment has failed.

Formerly, patients in Scotland had not had access to a reimbursed pharmacologic treatment option for BRVO. Patients with CRVO in England and Wales have had access to the dexamethasone treatment since mid-2011.

The biodegradable device delivers the anti-inflammatory medication into the back of the eye, using a specially designed applicator. Unlike other treatments for CRVO, a single injection of the dexamethasone formulation can be effective for up to 6 months, according to the company, requiring less frequent injections into the eye.

In clinical research involving 1,000 patients with CRVO, following one injection the dexamethasone implant significantly improved vision by 3 lines or more (or 15 letters) on an eye chart in up to 29% of patients with macular edema due to CRVO, according to the company. In some patients, this improvement was maintained for up to 6 months. Dexamethasone also was shown to improve or stabilize vision (defined as >0 letters change on an eye chart) in more than 80% of patients.

Side effects associated with use of the implant included discomfort on administration, bruising or bleeding on the surface of the eye, and an increase in IOP. The latter side effect was successfully treated with topical IOP-lowering medication in most patients, according to the company.

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