Allergan announced that it has received an imported drugs license from the Chinese Food and Drug Administration (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 RVO in China. Retinal vein occlusion 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," David Nicholson, Chief Research and Development Officer at Allergan, said in a company news release. "Inflammation is a critical component in RVO leading to macular edema and potential vision loss. Ozurdex suppresses mediators of inflammation and delivers rapid and sustained visual gains. As the prevalence of eye diseases and blindness grows in Asia, we are committed to improving access to innovative medicines and individualised treatments like Ozurdex that provide rapid improvements in visual acuityv and importantly, reduce the burden of injection for patients."
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.
"As a result of its clinical performance, Ozurdex was put on the priority approval list by the Chinese Food and Drug Administration. 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," Shirley Zhao, Allergan China President, said in the news release.
The clinical efficacy and safety of Ozurdex has been assessed in three phase 3 randomised, double-masked, sham-controlled studies. Based on the pooled analysis of the two global pivotal studies RVO1 and RVO2 as well as the China registration study RVO3 results, treatment with Ozurdex showed statistically significant improvements in visual gains compared with sham treatment. The most commonly-reported adverse events following treatment with Ozurdex are those frequently observed with ophthalmic steroid treatment or intravitreal injections (elevated IOP, cataract formation and conjunctival or vitreal haemorrhage respectively).
Commenting on the announcement, Marc Princen, Allergan International President said, "We are delighted to receive this approval, which means we can now provide RVO patients in China with an effective treatment option. China is a very important market for Allergan; it's the second largest pharmaceutical market in the world after the US and furthermore has the largest number of people with visual impairment and blindness globally. We are committed to bringing innovative treatments to these patients and help improve their quality of life."