Allergan (NYSE:AGN) said today that it landed an imported drugs license from the Chinese FDA to market its dexamethasone intravitreal implant, Ozurdex, as a treatment for adults with macular edema following branch retinal vein occlusion or central retinal vein occlusion.
The Dublin-based pharma giant touted its therapy as the first intravitreal injection approved for RVO in China.
“Ozurdex addresses a clear unmet need in Chinese patients with RVO, a potentially blinding disease if left untreated,” David Nicholson, Allergan’s chief R&D officer, said in prepared remarks. “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 individualized treatments like Ozurdex that provide rapid improvements in visual acuity and importantly, reduce the burden of injection for patients.”
Allergan’s Ozurdex is a biodegradable dexamethasone implant delivered with a single-use applicator. After the implant is injected into the back of a patient’s eye, the anti-inflammatory corticosteroid slowly releases over 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, president of Allergan’s China business, said.
“We are delighted to receive this approval, which means we can now provide RVO patients in China with an effective treatment option,” president of Allergan’s international business, Marc Princen, added. “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.”