China's regulatory body approves STAAR Surgical's ICL for myopia

STAAR Surgical Co. received approval by the People’s Republic of China’s State Food and Drug Administration (SFDA) to market the STAAR Visian implantable collamer lens (ICL) as a treatment for myopia.

STAAR Surgical Co. received approval by the People’s Republic of China’s State Food and Drug Administration (SFDA) to market the STAAR Visian implantable collamer lens (ICL) as a treatment for myopia.

“This approval is an important achievement for STAAR. It will allow us to enter a market that we believe has the potential to become one of the largest markets for the Visian ICL,” said David Bailey, president and CEO of STAAR Surgical. “Currently, China is the second largest market in the world for the LASIK procedure and there is a higher rate of incidence for myopia and astigmatism in Asian countries compared with the rest of the world. With these two market dynamics, we believe that successful entry into this market could lead to meaningful growth in our overall refractive business.”

Bailey added that a training center and regional distribution operation have been established, and was hopeful that the SFDA would approve the Visian Toric ICL by the end of the year.

“The SFDA’s approval [of Visian ICL] is an important milestone for the correction of myopia in our country,” said Professor Shen Ye, Zheyi Eye Center, Hangzhou, China. “The ICL allows the patient the opportunity to acquire excellent natural vision. Our clinic research indicates that the ICL has very high patient satisfaction levels.”