EyePoint Pharmaceuticals and OcuMension Announce Approval of Uveitis Treatment Yutiq in China
EyePoint Pharmaceuticals and OcuMension Therapeutics 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 noninfectious 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 pipeline.
In September 2020, OcuMension launched a real-world study of Yutiq for the treatment of chronic, noninfectious 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 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 3 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 3 years of continuous control in chronic, noninfectious 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,” she further stated.
“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, noninfectious uveitis affecting the posterior segment of the eye,” said Ye Liu, Chief Executive Officer of OcuMension Therapeutics.
“The OcuMension team has been working diligently to bring this potential best-in-class drug to Chinese patients as soon as possible, and I would like to express my sincerest gratitude to all of our colleagues in R&D, registration and commercialization that contributed diligently to Yutiq's approval. We would also like to thank Boao Lecheng Super Hospital for helping us execute the real-world study of Yutiq and our partners at EyePoint for their support in this registration and application. We are committed to bringing Yutiq to market as soon as possible to benefit Chinese patients in need.”
Yutiq received approval by the FDA on October 18, 2018. The treatment is currently marketed by EyePoint in the US, and EyePoint maintains development and commercialization rights for Yutiq for the treatment of noninfectious uveitis affecting the posterior segment of the eye in the Americas and in Asia.
