In a first, China approves eye implant based solely on real-world data

EyePoint Pharmaceuticals’ partner has received Chinese approval for an implant to treat a form of eye inflammation, becoming the first company to get a nod in the country based entirely on real-world data. Ocumension Therapeutics paid an initial $1.75 million to access EyePoint’s technology in 2018.

Ocumension filed for National Medical Products Administration (NMPA) approval of Yutiq in April 2021, claiming two firsts in the process. According to the biotech, the filing was the first submission for NMPA approval of a sustained-release micro-insert with a controlled release rate of up to 36 months and the first time the Chinese regulator had accepted a new drug application based on real-world study data. 

The positive NMPA decision triggered a further claim, namely that Yutiq is the first medicine approved in China based entirely on real-world data. Ocumension laid the groundwork for approval by teaming up with Boao Lecheng Super Hospital in September. Together, the hospital and Ocumension studied Yutiq in the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye. 

Ocumension said its research showed the fluocinolone implant Yutiq can significantly cut the recurrence rate and disease burden for patients with chronic noninfectious uveitis and improve visual acuity. The biotech called the safety profile of the treatment “favorable.” Ocumension CEO Ye Liu set out what the resulting approval means for the company. 

“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 posterior segment of the eye,” Liu said in a statement. “The Ocumension team has been working diligently to bring this potential best-in-class drug to Chinese patients as soon as possible.”

In its annual report, Ocumension said it aimed to win approval in 2022 and start sales the same year. The biotech allocated some of the proceeds of its 2020 Hong Kong IPO to the commercialization of the eye implant.