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FDA Confirms October 3rd STAAR ICL Panel Review

  • 2003-09-15
  • Press release

MONROVIA, Calif., Sep 15, 2003 /PRNewswire-FirstCall via COMTEX/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, announced today that the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has confirmed that it will review STAAR's Pre-Market Approval Application (PMA) for the Implantable Contact Lens (ICL) during the Ophthalmic Devices panel meeting on October 3, 2003.

The Company announced on July 1, 2003 that its ICL filing had been accepted for substantive review by the FDA and had been granted an expedited review status. The official filing date for the ICL PMA was May 8, 2003.

The STAAR ICL is a phakic refractive lens that provides state-of-the-art treatment for the most prevalent sight deficiencies -- near-sightedness, far-sightedness and astigmatism. The current submission is for the correction of myopia, or near-sightedness, in the range of -3.0D to -20.0D. The Company is presently enrolling candidates in the clinical trial for the hyperopic ICL as well as the Toric ICL, which reduces myopia combined with astigmatism.

STAAR's ICL has received CE Marking, is approved for sale in 37 countries and has been implanted in more than 30,000 eyes worldwide. If granted approval by the FDA, STAAR will be allowed to market the ICL in the United States for the reduction of near-sightedness.

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 the revolutionary Implantable Contact Lens as well as innovative products designed to improve patient outcomes for cataracts and glaucoma.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including any projections of earnings, revenue, or other financial items, any statements of the plans, strategies, and objectives of management for future operations, any statements concerning proposed new products and government approval of new products, services or developments, any statements regarding future economic conditions or performance, 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 the need to obtain regulatory approval for new products, acceptance of new products by medical practitioners and consumers, the rapid pace of technological change in the ophthalmic industry, general domestic and international economic conditions, and other factors beyond the control of STAAR Surgical Company, including those detailed from time to time in STAAR Surgical Company's reports filed with the Securities and Exchange Commission. STAAR Surgical Company assumes no obligation and does not intend to update these forward-looking statements.

    CONTACT:   Investors                        Media
               EVC Group                        EVC Group
               Douglas Sherk, 415-659-2285      Sheryl Seapy, 415-272-3323
               Jennifer Cohn, 415-659-2289

SOURCE STAAR Surgical Company

investors, Douglas Sherk, 415-659-2285, or Jennifer Cohn,
415-659-2289, both of EVC Group for STAAR Surgical Company; or media, Sheryl
Seapy of EVC Group, 415-272-3323, for STAAR Surgical Company
http://www.staar.com