China Uses Real-World Data to Approve Xen Stent


■ China’s National Medical Products Administration (NMPA) approved the registration of Allergan’s Xen Gel Stent for the surgical management of patients with refractory glaucoma. Xen is the first product to be approved in China through the Real World Evidence pathway.

To boost the reform of China’s medical device approval process and explore the value of the Real World Evidence pathway, the NMPA and the Hainan provincial government jointly initiated a Real World Evidence pilot program in Hainan in June 2019. When combined with data from controlled clinical trials conducted outside China, the real-world evidence data collection in Hainan province enabled the assessment of ethnic differences in treatment with Xen and supported approval by the NMPA.

Xen is approved in more than 30 countries and provides a new therapy for refractory glaucoma patients in China. The Xen System is used by ophthalmologists for the surgical management of refractory glaucomas, including cases in which previous surgical treatment did not work, cases of primary open-angle glaucoma, and cases of pigmentary glaucoma with open angles that are unresponsive to the maximum tolerated medical therapy. GP