MONROVIA, Calif., Feb. 29 /PRNewswire-FirstCall/ -- STAAR Surgical Company , a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced it has received approval from the State Food and Drug Administration of the People’s Republic of China (SFDA) to market the STAAR Visian(TM) Toric Implantable Collamer Lens to ophthalmologists and other eye care professionals in the country for the treatment of nearsightedness and astigmatism. In addition the SFDA granted approval to STAAR to market the STAAR Visian ICH, an implantable collamer lens to correct hyperopia or farsightedness.
“This approval has significant strategic importance for STAAR and positions us for continued growth in China,” said Barry G. Caldwell, President and CEO of STAAR Surgical. “The approval of both the Visian Toric ICL and the Visian Hyperopic ICL represents a solid endorsement of the STAAR technology. The Visian Myopic ICL was approved in China during July 2006 and has enjoyed significant growth. With these additional approvals, we are positioned to expand our presence in a market where the demographics are very favorable.”
According to Market Scope, a leading source for ophthalmic market data, there are over 500 million myopes and nearly 50 million hyperopes in China making it the largest potential refractive market in the world. In South Korea, where the population is believed to have a mean myopia rate similar to that of China, phakic implant procedures are estimated to have reached seven percent of the LASIK market. According to data presented at an ophthalmic meeting in Japan during January, STAAR’s Visian ICL and TICL were used in approximately 60% of those procedures. “Our goal in China over time is to at least replicate the market penetration we are achieving in South Korea,” Mr. Caldwell added.
Made of STAAR’s proprietary, highly biocompatible Collamer(R) material, the ICL, TICL and the ICH are the only minimally invasive foldable lenses of their kind approved for the Chinese commercial market. As a result of the unique foldable design, the ICL procedure allows an incision up to 50% smaller than competing technology, and its placement in the eye behind the iris provides a more aesthetically pleasing outcome. These approvals in China are for treatments of myopic patients with refractive errors between -3.00 and -20.0 and astigmatism up to six diopters. The hyperopic approval is for patients with refractive errors between +1.0 to +4.0.
About STAAR Surgical
STAAR is a leader in the development, manufacture and marketing of minimally invasive ophthalmic products employing proprietary technologies. STAAR’s products are used by ophthalmic surgeons and include the Visian ICL, a tiny, flexible lens implanted to correct refractive errors, as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. Manufactured in Switzerland by STAAR, the ICL is approved by the FDA for use in treating myopia, has received CE Marking and is sold in more than 40 countries. More information is available at http://www.staar.com.
Safe Harbor
All statements in this press release that are not statements of historical fact are forward-looking statements, including any statements of the plans, strategies, and objectives of management for future operations, any statements regarding expectations for success of the ICL, TICL or other products in China, the U.S. or other markets, statements of belief and any statements of assumptions underlying any of the foregoing. These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements. The risks and uncertainties include our limited capital resources and limited access to financing, the challenge of managing foreign subsidiaries, the willingness of surgeons and patients to adopt a new product and procedure and other factors beyond our control, including those detailed from time to time in our reports filed with the Securities and Exchange Commission. STAAR assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes and does not intend to do so.
CONTACT: Investors, Douglas Sherk, +1-415-896-6820, or Matthew Selinger,
+1-415-896-6817, or Media, Steve DiMattia, +1-646-277-8706, all of EVC
Group for STAAR Surgical Company
Web site: http://www.staar.com/
