Allergan announced China’s National Medical Products Administration (NMPA) approved the registration of Allergan’s Xen Gel Stent on March 26, 2020 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 Hainan Provincial Government jointly initiated a Real World Evidence pilot program in Hainan in June 2019. Allergan partnered with the Hainan Boao Lecheng International Medical Tourism Pilot Zone and obtained permission to use Xen in clinical practice at the Lecheng Pilot Zone in April 2019 in accordance with the policy for urgently needed imported medical devices.
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 to treatment with Xen and supported approval by the NMPA. Real world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product from analysis of real world data. Real world evidence can be generated by different study designs or analyses, including randomized trials.
“We are honored that Xen has become the first medical product approved in China using real world evidence,” David Nicholson, EVP and Chief R&D Officer at Allergan, said in a company news release. “As a global biopharmaceutical and medical device leader, Allergan has a broad product offering and a deep R&D pipeline. 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 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 where previous surgical treatment did not work, cases of primary open-angle glaucoma, and cases of pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.