Healthcare Industry News:  cataract 

Devices Ophthalmology

 News Release - January 11, 2006

STAAR Surgical Announces First Myopia Treatment Using the VISIAN ICL(TM)

STAAR Surgical VISIAN ICL Offers Adults a Minimally Invasive Alternative for Correction of Nearsightedness
First Procedure in U.S. After Clinical Trials; Patient's Eyesight Improved From Inability to See Largest Letter on Vision Chart to 'Better than 20/20'


MONROVIA, Calif., Jan. 11 (HSMN NewsFeed) -- STAAR Surgical Company (Nasdaq: STAA ), today announced that the first VISIAN ICL(TM) (Implantable Collamer Lens) has been surgically implanted in the U.S. since the Food and Drug Administration approved the premarket approval application for the lens in December 2005. Dr. John Vukich, ophthalmic surgeon and medical director at the Davis Duehr Dean Medical Center in Madison, Wisconsin, performed the procedure on January 10, 2006, which resulted in a dramatic improvement in the patient's vision. The patient had previously only been able to count fingers when placed one foot in front of her. Dr. Vukich reported that post- operatively her vision was "better than 20/20."

The VISIAN ICL is the only foldable, minimally invasive lens approved for the correction of myopia, or nearsightedness, in adults.

During the six-minute, topical anesthetic procedure, Dr. Vukich made a micro incision to allow positioning of the implant behind the iris, or the colored part of the eye. "The 36-year old female patient had -9.5 diopters of myopia before the procedure and was unable to see the largest letter on the standard vision chart," said Dr. Vukich. "Post-operatively, the patient was able to see letters smaller than the 20/20 visual acuity would allow. She showed significant improvement instantaneously, and within one hour following the procedure was able to see better than 20/20 without eyeglasses."

"Immediately after the ICL procedure, the patient sat up and read the time off the clock across the room," added Dr. Vukich. "The VISIAN ICL is an exciting technological advancement and it will allow a great number of individuals suffering from nearsightedness to enjoy clear vision without glasses. The ICL has been shown to be a safe, minimally invasive procedure that has produced outstanding clinical outcomes, and it is a significant improvement to the ophthalmic surgeon's arsenal."

The Company indicated that Stephen Slade, M.D., in Houston, Texas; David Schneider, M.D. in Cincinnati, Ohio; and Paul Dougherty, M.D., in Los Angeles, California, would also be performing VISIAN ICL surgeries this week.

STAAR cautions that individual patient results will vary. Not all patients will achieve 20/20 vision or better.

About the VISIAN ICL

Made of a highly biocompatible Collamer® material containing a small amount of collagen, the VISIAN ICL's unique lens design allows for an incision 50% smaller than competing technology and for a more aesthetically pleasing outcome, because the lens is placed behind the iris. The procedure is also reversible, as the lens can be removed without permanently altering the structure of the eye.

Currently, more than 860 surgeons in the U.S. have completed the first phase of training toward becoming certified to conduct the procedure. Doctors familiar with the technology have noted the ICL's stability, the safety of the procedure, superior clinical outcomes and high patient satisfaction rate. In addition to the U.S., the ICL is approved for sale in 41 countries (including the European Union) and has been successfully implanted in more than 40,000 eyes worldwide.

The VISIAN ICL is a refractive phakic implant intended for placement in the posterior chamber of the eye. The approved models are indicated for the correction of myopia in adults with myopia ranging from -3.0 to less than or equal to -15.0 diopters, with astigmatism less than or equal to 2.5 diopters at the spectacle plane, and the reduction of myopia in adults with myopia ranging from greater than -15.0 to -20.0 diopters with astigmatism less than or equal to 2.5 diopters at the spectacle plane, in patients 21 to 45 years of age 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. The safety and effectiveness of the VISIAN ICL is not established for patients who fall outside these requirements. Additional information on the safety and effectiveness of the VISIAN ICL will be available on the FDA website at www.fda.gov/cdrh/pdf3/p030016.html.

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 VISIAN ICL as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. STAAR's ICL has received CE Marking, is approved for sale in 41 countries and has been implanted in more than 40,000 eyes worldwide. More information is available at 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 expectations for success of the ICL in U.S. or international markets, 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, 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 or enhance our existing product sales and 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.


Source: STAAR Surgical

Issuer of this News Release is solely responsible for its content.
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