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EyePoint Pharmaceuticals and OcuMension Therapeutics Announce Approval of New Drug Application by China’s NMPA for YUTIQ® for the Treatment of Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
WATERTOWN, Mass. and BEIJING, June 21, 2022 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to
About this update from Eyepoint, Inc.
[{"type":"text","content":"WATERTOWN, Mass. and BEIJING, June 21, 2022 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, and OcuMension Therapeutics (HKSE: 1477), a fast-growing ophthalmology focused pharmaceutical company in China, today announced that China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has approved YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18mg for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. YUTIQ is the first drug approved for commercialization in China based entirely on real-world data, as well as the first drug approved for commercial use in OcuMension’s innovative pipeline. In September 2020, OcuMension launched a real-world study of YUTIQ for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye at Boao Lecheng Super Hospital in Hainan Province through the urgent clinical need channel granted to Boao Lecheng Pilot Zone. In April 2021, the CDE accepted OcuMension’s new drug application (NDA) for YUTIQ that was filed with the real-world data collected at Boao Lecheng Super Hospital. “YUTIQ’s approval in China marks an important milestone for EyePoint and OcuMension’s shared mission of bringing sustained-release drug delivery treatments to patients with debilitating diseases of the eye,” said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. “Since YUTIQ’s U.S. approval over three years ago, EyePoint has been able to deliver this innovative ocular therapy and provide an improved standard of care for patients by providing up to three years of continuous control in chronic, non-infectious uveitis affecting the posterior segment of the eye. We are proud to partner with OcuMension and expand YUTIQ’s global reach in the emerging Chinese market as we work together to improve the lives of patients with serious eye disorders.” “We are thrilled to announce the new drug approval for YUTIQ in China. This approval marks the first-ever treatment approved from OcuMension’s innovative pipeline and, more importantly, a critical therapeutic advancement for patients suffering from chronic, non-infectious uveitis affecting the posteri...