BRIEF—China approves Allergan's Ozurdex

30 October 2017

Ireland-incorporated Allergan has received an Imported Drugs License (IDL) from the Chinese Food and Drug Administration (CFDA) to market Ozurdex (dexamethasone intravitreal implant 0.7mg) for the treatment of adult patients with macular edema following either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO).

Ozurdex is the first approved intravitreal injection for RVO in China.

Retinal vein occlusion (RVO) is the second most common type of retinal vascular disorder after diabetic retinal disease and one of the most common causes of sudden, painless, unilateral loss of vision.

It is estimated that there are around 7.4 million patients in China with RVO who require treatment.

"Ozurdex addresses a clear unmet need in Chinese patients with RVO, a potentially blinding disease if left untreated," explained David Nicholson, chief research and development officer at Allergan.

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