MONROVIA, Calif., Apr. 28 /PRNewswire-FirstCall/ -- STAAR Surgical Company today announced that it has submitted a Pre-Market Approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for its Visian TICL, a toric implantable Collamer(R) lens designed to treat both nearsightedness and astigmatism.
STAAR submitted the Visian TICL application as a supplement to the PMA for its Myopic Visian ICL(TM), which the FDA approved on December 22, 2005 for use in correction of myopia in adults and which is now available to patients in the U.S. The review time period for a PMA supplement is typically 180 days from the date of submission to the FDA.
The Visian TICL supplemental filing supports an indication for use in adults 21 to 45 years of age for the correction of myopia ranging from -3.0 to -20 diopters with astigmatism of 1 to 4 diopters. 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.
Made of STAAR's proprietary, highly biocompatible Collamer material, the Visian ICL is the only minimally invasive, foldable lens of its kind approved for the U.S. commercial market, and its placement in the eye behind the iris provides a more aesthetically pleasing outcome than competing refractive implants. The Visian TICL shares the same unique, foldable design, and like the Visian ICL, it is implanted through a small incision, approximately 3 mm. The difference in the Visian TICL is its toric optical design, which permits the surgeon to correct both spherical and cylinder refractive conditions in a single, quick procedure.
"We are very pleased to submit our supplemental PMA for the Visian TICL," said David Bailey, President and CEO of STAAR Surgical. "The submitted data indicates very positive surgical outcomes, in fact, 98% of all patients reported that they were 'very' or 'extremely' happy with the surgical results and no patients were dissatisfied. The Visian line remains our most significant opportunity for profitable growth in the future and our submission of the TICL PMA supplement is another important milestone toward executing our long-term strategy. If approved, the TICL will be the only phakic implantable lens product available in the U.S. to treat myopia and astigmatism. Based on the interest we have seen in international markets where the TICL is already approved, we believe our product can uniquely serve the growing needs of the dynamic refractive market in the U.S."
The Visian TICL is a refractive phakic implant intended for placement in the posterior chamber of the eye. The supplemental filing supports an indication for the correction of myopia 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 42 countries. More than 50,000 ICLs/TICLs have been sold worldwide. More information is available at 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 approval of the Visian TICL, expectations for success of the Visian product line in the U.S. or international markets, and any statements of the plans, strategies, and objectives of management for future operations, 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 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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STAAR Surgical Company