MONROVIA, Calif., Nov. 27 /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 nearsightedness and astigmatism. In a letter received on November 20, 2006, the FDA's Office of Device Evaluation requested that STAAR amend its submission to provide additional information and analyses of clinical data to permit the agency to complete its review of the TICL's safety and effectiveness. The FDA indicated that evaluation of the amendment could extend the review period by up to 180 days after submission of the amendment.
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. STAAR's submission for TICL approval was initially delayed to allow for an astigmatism analysis based on a scientific paper of the American National Standards Institute (ANSI) Subcommittee on Astigmatism authored by FDA staff, prominent ophthalmologists and industry representatives.
"The FDA's careful groundwork for the entire field of toric phakic implants has led to a request for analyses on the Visian TICL that go beyond the general experience of the industry in this area. This request is in addition to more routine types of follow-up questions the Agency has regarding the Visian TICL. As a result of the scope of the information requested, any potential approval of the product will take longer than we originally anticipated," observed David Bailey, CEO of STAAR. "While it was possible that the timeline would have been shorter, the FDA's request is not unusual given that it is considering the submission for a first-of-its kind product.
Because our safety and effectiveness data rests on the record established by the recently approved Visian ICL(TM) for myopia, the FDA has also asked for additional data regarding a transitory rise in the rate of excessive ICL vaulting we reported earlier this year. We believe that this resulted from the learning curve of our surgeons in measuring and assessing key variables, and would point out that over the last four months the free sale rate of occurrence of excessive vaulting has been well below the 0.6% rate reported during U.S. clinical trials." Mr. Bailey added.
"We are pleased with this data point along with other longer term follow up from the US clinical trial where the cohort of 526 eyes now includes follow up on 73% at four years or later and 59% at five years or later. Data from this gold standard trial serves only to increase our confidence in the long- term safety of the Visian ICL device," said Mr. Bailey. "At the American Academy of Ophthalmology (AAO) meeting earlier this month we reported favorable long-term trends on two key safety variables -- cataracts and endothelial cell counts. Clinically significant anterior subcapsular cataracts were observed in a cumulative total of only 1.3% of cases, and no other types of cataract were observed since the PMA was submitted. Cumulative endothelial cell loss at five years postoperatively was 12.5% and cell morphology was most consistent with corneal endothelial remodeling with early stabilization and not chronic endothelial cell loss," Mr. Bailey concluded.
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. Approximately 65,000 ICLs and TICLs have been sold worldwide. 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 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 our limited capital resources and limited access to financing, the need to secure FDA approval before marketing the Visian TICL in the U.S., our 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 our ability to successfully launch and market the ICL in the U.S. while overcoming the foregoing challenges. Our ability to capitalize on the opportunity presented by the ICL approval depends on our overall financial condition, which can be adversely affected by our ability to implement our cost savings strategies and realize our expected savings, our ability to reverse the decline in domestic sales of intraocular lenses, our ability to maintain gross profit margin and reduce compliance expenditures, the rapid pace of technological change in the ophthalmic industry, our ability to compete with much larger ophthalmic companies, general domestic and international economic conditions, 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.
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