Ruitai Bio’s Epicon A, a scleral lens product from Australia, has been approved by the National Medical Products Administration (NMPA) in China, marking it as the 10th novel product supported by Lecheng’s real-world data. This Category III medical device is set to make a significant impact on the correction of irregular astigmatism and the enhancement of visual quality for refractive error patients in China.
Correcting Irregular Astigmatism with Epicon A
Epicon A is designed to correct irregular astigmatism caused by various conditions, including Keratoconus, irregular cornea, corneal degeneration, corneal dystrophy, corneal ulcer, trauma, corneal transplantation, and refractive surgery. As a daily hard scleral contact lens, it is the first scleral lens to be approved for marketing in China, offering a new option for patients seeking improved visual outcomes.
Lecheng’s Real-World Data Application and Patient Benefits
Epicon A initially entered the Chinese market through the “first pilot, first trial” pathway in Lecheng of Boao, Hainan, where it was included in the real-world data application pilot. The product has since benefited over 300 patients, demonstrating its effectiveness and safety in real-world settings. The approval of Epicon A by the NMPA is a testament to the value of Lecheng’s real-world data in supporting the approval of innovative medical devices.-Fineline Info & Tech
