The National Institute for Health and Clinical Excellence (NICE) has recommended Allergan’s OZURDEX (dexamethasone 0.7mg intravitreal implant in applicator) for the treatment of macular oedema due to central retinal vein occlusion (CRVO).
NICE has also recommended the implant for branch retinal vein occlusion (BRVO) where laser photocoagulation is neither beneficial nor appropriate.
OZURDEX is a biodegradable intravitreal implant containing dexamethasone, a highly potent corticosteroid, administered via a specially designed, single use applicator.
Dexamethasone is slowly released from the implant into the eye and acts locally to control oedema, reduce inflammation around the occlusion and improve vision.
The efficacy of OZURDEX was assessed in two 6-month, prospective, double-masked, parallel-group studies in which 1267 patients with macular oedema due to either branch or central retinal vein occlusion (BRVO or CRVO) were randomised to receive either OZURDEX or a sham (placebo) procedure.
Clinically significant improvement in vision (defined as [greater than or equal to]15 letters or 3 lines on an eye chart) was seen after 2 months in up to 30% of patients with macular oedema due to RVO following just one injection of OZURDEX.
In some patients this improvement was maintained for up to 6 months.
Importantly, up to 80% of patients had an improvement or no worsening in vision over the 6 months (defined as >0 letters on an eye chart).
The most frequently reported adverse reactions in patients who received OZURDEX were increased intraocular pressure (24%) and conjunctival haemorrhage (14.7%).
Allergan, Europe, Africa and the Middle East EVP and president Douglas Ingram said they look forward to working with retinal specialists, hospitals and commissioning groups in the UK to support the National Health Service in rapidly adopting this cost effective solution to maximise patient benefits and to minimise premature vision loss as a result of RVO.