First Company to Apply for Pre-Market Approval of a Phakic Lens to Treat Myopia

MONROVIA, Calif., May 8 /PRNewswire-FirstCall/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, announced today that it has submitted the final module of its Pre-Market Approval Submission for its Implantable Contact Lens (ICL(TM)) to the U.S. Food and Drug Administration. This submission includes clinical data fulfilling the FDA's requirement for three-year clinical follow-up. When granted approval, STAAR will be allowed to market the ICL in the United States for the reduction of near-sightedness.

"The submission of the third and final module of our PMA is a significant milestone in the development of the ICL," said Helene Lamielle, M.D., vice president of Scientific Affairs at STAAR. "With our first two modules already approved, this submission and the subsequent approval are the final steps in the regulatory process necessary to complete before STAAR will be able to commercialize the ICL for myopia is the U.S."

"The ICL continues to represent STAAR's most significant growth opportunity going forward," said David Bailey, president and CEO of STAAR Surgical. "We believe that the thorough application that we have submitted, coupled with the continuous positive clinical outcomes, strengthen our industry leading position within the phakic refractive lens market. Worldwide, our ICLs have been implanted in more than 30,000 eyes with very positive results. We are very pleased with patient outcomes and satisfaction with this product. We continue to expect to be the first to market with this revolutionary technology within the United States."

The STAAR ICL(TM) 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 currently enrolling candidates in the clinical trial for the hyperopic ICL as well as the Toric ICL, which reduces myopia combined with astigmatism.

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, Douglas Sherk, +1-415-659-2285, or Jennifer Cohn, +1-415-659-2289, or media, Sheryl Seapy, +1-415-272-3323, all of EVC Group, for STAAR Surgical Company.

SOURCE  STAAR Surgical Company
    -0-                             05/08/2003
    /CONTACT:  investors, Douglas Sherk, +1-415-659-2285, or Jennifer Cohn,
+1-415-659-2289, or media, Sheryl Seapy, +1-415-272-3323, all of EVC Group,
for STAAR Surgical Company/
    /Web site:  http://www.staar.com/
    (STAA)

CO:  STAAR Surgical Company
ST:  California
IN:  CPR HEA MTC
SU:



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8867 05/08/2003 06:30 EDT http://www.prnewswire.com