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STAAR Surgical receives approval to market Visian ICL in Japan
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MONROVIA, Calif. — The Japanese Ministry of Health, Labor and Welfare has granted STAAR Surgical approval to market its Visian Implantable Collamer Lens for treating myopia, STAAR announced in a press release. This marks the first approval of a phakic lens in Japan, the company said.
STAAR plans to hold its first ICL certification course in March and to begin generating revenue from the ICL product line during the first half of 2010, according to the release.
"Today's announcement represents the achievement of a major milestone for STAAR and presents us with an opportunity to pursue a very attractive market for the Visian ICL," Barry G. Caldwell, president and CEO of STAAR Surgical, said in the release. "The Tajimi Study, which evaluated the prevalence of myopia in Japan, reported that the prevalence of myopia was much higher in Japan than in most other parts of the world. Japan is currently the third largest refractive market and offers an opportunity for additional growth."
Following discussions with Japan's Pharmaceuticals and Medical Device Agency, STAAR expects to file a partial change application for approval of its Visian toric ICL. The Ministry of Health, Labor and Welfare generally requires up to 1 year to complete a partial change application.