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STAAR Surgical receives approval to market Visian ICL in China
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MONROVIA, Calif. — STAAR Surgical Co. has received approval from the State Food and Drug Administration of the People’s Republic of China to market its Visian ICL, the company announced.
The approval will allow the company to enter the Chinese lens market, which company officials believe could become one of the largest markets for the Visian ICL. Asian countries have a higher incidence of myopia and astigmatism compared to the rest of the world, and currently China represents the second-largest LASIK market worldwide, according to a press release.
“With these two market dynamics, we believe that successful entry into [the Chinese] market could lead to meaningful growth in our overall refractive business,” David Bailey, president and CEO of STAAR, said in the release.
“We have already established a training center, as well as a regional distribution operation in China,” Mr. Bailey added. “A proctor has been hired and we expect to begin procedures in August. We also continue to pursue approval from the [Chinese State Food and Drug Administration] for the Visian Toric ICL and are hopeful that we will receive approval by the end of the current year.”
The Visian ICL is made from STAAR’s biocompatible Collamer material and is designed for placement behind the iris through an incision up to 50% smaller than competing technologies.
The ICL is the only minimally invasive foldable lens of its kind approved for the Chinese market, company officials noted in the release.