Allergan Gets China Approval For Ozurdex To Treat Retinal Vein Occlusion

(RTTNews) - Allergan plc (AGN) announced Monday that it has received an Imported Drugs License or IDL from the Chinese Food and Drug Administration or CFDA to market Ozurdex (dexamethasone intravitreal implant 0.7 mg) 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 Retinal vein occlusion or RVO in China. 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.

The company noted that it is estimated that there are around 7.4 million patients in China with RVO who require treatment.

Ozurdex is a biodegradable implant containing dexamethasone, an anti-inflammatory corticosteroid, in a single use applicator. Following an intravitreal injection into the back of the eye, the implant slowly releases the dexamethasone directly to the retina over a period of several months.

Shirley Zhao, Allergan China President, said, "As a result of its clinical performance, Ozurdex was put on the priority approval list by the Chinese Food and Drug Administration (CFDA). The approval of Ozurdex underscores our commitment to bring more innovative eye care solutions to tackle unmet medical needs in China. Coming next, Allergan China will be accelerating access to Ozurdex for Chinese hospitals - and more importantly to Chinese patients."

The clinical efficacy and safety of Ozurdex has been assessed in three phase III randomised, double-masked, sham-controlled studies. The study results showed that treatment with Ozurdex showed statistically significant improvements in visual gains compared with sham treatment.