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STAAR Surgical Submits Two of Three Modules of the Pre-Market Approval Submission to the FDA for its ICL(TM)

  • 2002-04-25
  • Press release
MONROVIA, Calif., Apr 25, 2002 /PRNewswire-FirstCall via COMTEX/ -- STAAR Surgical Company (Nasdaq: STAA) announced today that it has submitted two of the three modules of the pre-market approval (PMA) submission to the United States Food and Drug Administration (FDA) for the Implantable Contact Lens (ICL) ahead of projected schedule.

The Company requested that the FDA allow their pre-market approval (PMA) application for the ICL to be submitted in a modular format. This form of submission allows the FDA to individually review each section in a timely manner. The last module will contain the clinical data and will be submitted as soon as the Company fulfills the requirements as outlined by the FDA.

Helene Lamielle, M.D., Vice President of Scientific Affairs explains, "The modular format provides the FDA the opportunity to review the material ahead of time and speeds the feedback to the Company regarding important information."

STAAR submitted the first of three modules, the "Pre-Clinical Data" section on March 28, 2002. On April 19, the company submitted its second module, "Manufacturing Information."

"Our staff has done an excellent job submitting the first two modules ahead of schedule for our premier product, the ICL," said David Bailey, CEO and President. "This is an excellent example of how we are committed to meet or exceed our plan to provide the ophthalmic industry with excellent products through advanced technology, while providing shareholders a strong return on their investment in STAAR Surgical Company."

The ICL is a surgically implanted lens that uses optical concepts similar to contacts or spectacles lenses to achieve vision correction. The optic of the lens is customized to address each patient's refractive error. Surgeons implant the ICL in front of the human lens in a matter of minutes. Unlike laser refractive correction, the ICL makes no permanent change in the structure of the eye and the procedure is reversible.

Founded in 1982, STAAR Surgical Company develops, manufactures and globally distributes medical devices for use in refractive, cataract and glaucoma surgery. The Company's five product lines include silicone and Collamer(TM) foldable intraocular lenses and the Sonic WAVE(TM) phacoemulsification system, all of which are used during cataract surgery, the ICL(TM) (implantable contact lens) which is a refractive lens for the treatment of near- and far-sightedness and the AquaFlow(TM) Collagen Glaucoma Drainage Device. Regulatory approvals vary from market to market with all products except the Toric ICL(TM) available in Europe and all except the ICL(TM) in the United States.

For additional information, about STAAR Surgical, visit the Company's web site at or You may wish to contact David Bailey, President, STAAR Surgical, or John Bily, Chief Financial Officer, STAAR Surgical, at (626) 303-7902. To contact Bill Roberts, President, CTC, Inc., or Wayne Buckhout, CTC Inc., please call (937) 434-2700

Certain statements in this press release constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements involve risks and uncertainties that may cause the Company's actual results to be materially different. Factors that could impact the Company's future results are set forth in the cautionary statements included in Exhibit 99 to the Company's latest Form 10-K filed with the Securities and Exchange Commission.

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CONTACT:          David Bailey, President, STAAR Surgical, or John Bily, Chief
                  Financial Officer of STAAR Surgical, +1-626-303-7902, or Bill Roberts,
                  President, or Wayne Buckhout, of CTC Inc., +1-937-434-2700

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