Xen approved for refractory glaucoma in China
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China’s National Medical Products Administration approved the use of the Xen gel stent for the surgical management of patients with refractory glaucoma, according to an Allergan press release.
The National Medical Products Administration and Hainan Provincial Government created a real-world evidence pilot program in June 2019. When combined with data from controlled clinical trials, the real-world data enabled the assessment of ethnic differences to treatment with Xen, which helped to support the approval of the gel stent.
“We are honored that Xen has become the first medical product approved in China using real-world evidence,” David Nicholson, executive vice president and chief R&D officer at Allergan, said in the release. “We are committed to improving the accessibility of our innovative products and working with local and national officials to speed their introduction into China to address unmet needs of Chinese physicians and patients.”
Xen is approved in more than 30 countries and is used for patients with refractory glaucoma, primary open-angle glaucoma and pigmentary glaucoma with open angles unresponsive to medical therapy.