February 6, 2007
STAAR Surgical Provides Update on Toric ICL Application With FDA
MONROVIA, Calif., Feb. 6 /PRNewswire-FirstCall/ -- STAAR Surgical Company today provided an update on the status of the Company's submission to the U.S. Food and Drug Administration (FDA) for approval of its Visian TICL(TM), a toric implantable Collamer(R) lens designed to treat both myopia and astigmatism. STAAR announced that its representatives met with the staff of the FDA Office of Device Evaluation on January 31, 2007 to discuss the FDA's comments on STAAR's Supplemental Premarket Approval application for the TICL received by letter on November 20, 2006. At the meeting, the FDA staff indicated that, because the TICL is the first toric phakic implantable lens to be reviewed, STAAR's amended application for the TICL would be submitted to the Ophthalmic Devices Panel of the Center for Devices and Radiological Health for evaluation.
"It is highly unusual for a supplemental application to be submitted to the Panel for review," noted David Bailey, President and CEO of STAAR. "However, as the staff observed, the TICL is a first-of-its-kind device and we look forward to providing all necessary support to substantiate its safety and effectiveness. We had hoped for faster review, but based on this feedback we believe that approval of the TICL will be unlikely in 2007, as previously anticipated."STAAR submitted the Visian TICL application on April 28, 2006 as a supplement to the pre-market approval application for its Myopic Visian ICL(TM), which the FDA approved in December 2005 for use in correction of myopia in adults and which is now available to patients in the U.S. The Visian TICL, which is sold for the correction of astigmatism outside of the U.S., including in Europe and some Asian nations, is a refractive phakic implant intended for placement in the posterior chamber of the eye. Astigmatism, which is usually caused by uneven curvature of the surface of the eye, causes light rays to focus at different points inside the eye. A person with astigmatism will experience blurriness in part of the visual field in both near and distance vision. The supplemental filing supports an indication for the correction of myopia and astigmatism in adults with myopia ranging from -3.0 to less than or equal to -20.0 diopters with astigmatism ranging from 1 diopters to 4 diopters at the spectacle plane, with anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopters for one year prior to implantation.
About STAAR Surgical
STAAR Surgical 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 STAAR's 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. STAAR's ICL is approved by the FDA for use in treating myopia, has received CE Marking and is approved for sale in 43 countries. More than 65,000 ICLs and TICLs have been sold worldwide. More information is available at http://www.staar.com/.
All statements in this press release that are not statements of historical fact are forward-looking statements, including any statements regarding the likelihood or timing of U.S. approval of the Visian TICL. 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 STAAR's limited capital resources and limited access to financing, the need to secure FDA approval before marketing the Visian TICL in the U.S., STAAR's ability to overcome negative publicity resulting from warning letters and other correspondence from the FDA Office of Compliance, the willingness of surgeons and patients to adopt a new product and procedure, and its ability to successfully launch and market the ICL in the U.S. while overcoming the foregoing challenges. STAAR's business can be adversely affected by its ability to implement its cost savings strategies and realize its expected savings, its ability to reverse the decline in domestic sales of intraocular lenses, its ability to maintain gross profit margin and reduce compliance expenditures, the rapid pace of technological change in the ophthalmic industry, its ability to compete with much larger ophthalmic companies, general domestic and international economic conditions, and other factors beyond its control, including those detailed from time to time in the Company's 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 Jennifer Beugelmans, +1-646-201-5447, or Media, Jen Saunders, +1-646-201-5431, all of EVC Group.
STAAR Surgical Company
CONTACT: Investors, Douglas Sherk, +1-415-896-6820, or JenniferBeugelmans, +1-646-201-5447, or Media, Jen Saunders, +1-646-201-5431, all ofEVC Group
Web site: http://www.staar.com/