STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, announced today regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market the Company's Visian Implantable Collamer® Lens (ICL) in Japan.
Japan's MHLW approved marketing the Visian ICL for the treatment of myopia. The Japanese population is believed to suffer one of the highest rates of myopia in the world, with a much higher percentage of the population in the high myopic range than the worldwide norm. Market Scope, the industry leading ophthalmic research firm, reports that the worldwide average prevalence of myopia is 23% of the population, while the prevalence in Japan is 45%. This compares to an estimated 27% prevalence of myopia in the U.S. Over 150,000 Visian ICLs have been implanted worldwide since its introduction.
"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," said Barry G. Caldwell, President and CEO of STAAR Surgical. "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. This also represents the first approval of the Collamer lens material in Japan and hopefully this can lead to future Collamer lens approvals."
"We are very excited to introduce the Visian ICL technology in Japan," added David Bailey, President of International Operations. "Our organization has been working with the regulatory agencies for several years, and this marks the first Phakic lens approval for the Japanese market. With the Visian ICL approval, our team at STAAR Japan is swiftly executing our controlled launch plan to maximize both surgeon adoption and patient satisfaction, and we currently expect to hold our first ICL Certification Course at the end of March and begin generating revenue from the product line during the first half of 2010."
"The Visian ICL is a posterior phakic IOL and has the value not only in safeness due to reversible character, but also in superior visual performance after surgery," said Dr. Kimiya Shimizu, Professor and Chairman of the Department of Ophthalmology at Kitasato University. "Because Visian ICL can be less affected by the healing reaction of the corneal wound which differs in patients, it shows better stability and prediction accuracy compared to LASIK. No expensive laser equipment is necessary and the surgical procedure is easy for experienced cataract surgeons. Among different methods of vision correction, the Visian ICL is the best method theoretically and this product expands its application not only to high myopia but also to medium myopia. This is a new encouraging choice for refractive surgery and I assume that this will be popular widely in the Japanese market."
Having achieved ICL approval, STAAR now intends to file a partial change application for approval of the Visian Toric ICL approval in Japan as soon as practicable following discussions with the Pharmaceuticals and Medical Device Agency(PMDA). MHLW generally requires up to one year to fully process a partial change application, although that timeline can change based on the nature of the product under review.