NICE thumbs up for Allergan’s Ozurdex

pharmafile | June 9, 2011 | News story | Sales and Marketing Allergan, BRVO, CVRO, NICE, Ozurdex 

In draft guidance NICE has recommended the use of Allergan’s eye treatment Ozurdex.

NICE’s final decision on Ozurdex (dexamethasone) is expected next month but their green light is good news for Allergan and its implant treatment for macular oedema following central retinal vein occlusion (CVRO).

Macular oedema is where fluid collects in the retina leading to severe visual impairment. Ozurdex is injected into the eye every six months to suppress inflammation.

Retinal vein occlusion (RVO) increases with age and other risk factors include diabetes, glaucoma, high cholesterol and blood pressure.

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Ozurdex is also recommended following branch retinal vein occlusion (BRVO) when treatment with laser photocoagulation has not been beneficial or suitable.

Peter Littlejohns, clinical and public health director at NICE, said: “After receiving the information requested from the manufacturer following the consultation, we are pleased to be able to recommend dexamethasone intravitreal implant for this condition. RVO can be very debilitating and have a very profound effect on everyday life so this draft decision will be welcome news to all those affected.”

Before arriving at the decision, NICE had asked Allergan for further details on the location and extent of macular haemorrhage for the subgroup of patients for whom laser treatment was not considered appropriate.

It had also asked Allergan for additional information regarding costs and clinical information of the treatment, compared with Roche/Genentech’s Avastin.

Meanwhile, Allergan has announced head-to-head trials of the drug with Novartis’ Lucentis in a year-long study conducted in Europe and Israel, which sees the first patient being enrolled this summer.

Brett Wells

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