The CustomVue procedure tailors a unique correction for each individual. It employs the VISX WaveScan System, a new diagnostic system that captures a "fingerprint" of the eye which is 25 times more precise than what was previously measurable by standard methods. WaveScan evaluates more than nearsightedness, farsightedness, and astigmatism; it captures other, more specific imperfections in each individual's vision. This data is then used to generate an individualized treatment for a CustomVue procedure.
Dr. Robert Maloney, Director of the Maloney Vision Institute and Associate Clinical Professor of Ophthalmology, UCLA School of Medicine, participated in the VISX multi-center clinical study. Dr Maloney stated, "The results from CustomVue procedures are very impressive, with potential for sharper vision and improved night vision over contacts and glasses. There is no question that this technology is a significant step forward in the advancement of laser vision correction."
The VISX clinical study results that were the basis of the Company's FDA approval exceeded all of the FDA required measurements for safe and effective laser vision correction. The FDA approval allows for WaveScan diagnosis and CustomVue treatment of patients with nearsightedness and astigmatism.
Clinical data presented at the American Society of Cataract and Refractive Surgery 2003 Symposium and Congress in San Francisco showed that at one year following the procedure, all of the follow-up examinations indicated that participants could pass a driving test to drive without glasses or contacts. 98% of the participants could see 20/20 or better and nearly 70% could see better than 20/20 without glasses or contacts. A six-month evaluation of clinical study participants showed that four times as many people were very satisfied with their night vision after the VISX CustomVue procedure, compared to their night vision before with glasses or contacts.
"Our goal is to continue to introduce new technologies that advance laser vision correction. We are very pleased to be the first on the U.S. market with approval of laser vision correction for both nearsightedness and astigmatism. We are now moving ahead with an FDA approved human clinical study for CustomVue procedures for the treatment of farsightedness," stated Liz Dávila, chairman and chief executive officer of VISX.
About the market for Laser Vision Correction:
It is estimated that in the U.S. alone, there are 50 to 60 million people that are good candidates for laser vision correction. The majority of these people require vision correction for myopia and astigmatism.
About VISX:
VISX is a worldwide market leader in the design, manufacture, and sale of laser vision correction systems. Ophthalmologists have performed over 5 million procedures using VISX Systems, reducing or eliminating completely the need for contacts or glasses. Additional information on VISX and VISX trained and certified ophthalmologists can be found on the worldwide web at www.VISX.com.
This press release contains certain forward-looking statements based on current expectations, forecasts, and assumptions of VISX that involve risks and uncertainties. Forward-looking statements in this release, including our plans to initiate clinical trials for farsightedness, are based on information available to the Company as of the date hereof. The Company's actual results could differ materially from those stated or implied in such forward-looking statements, due to risks and uncertainties associated with the Company's business, which include the risk factors disclosed in the Company's most recent filings with the Securities and Exchange Commission, including VISX's Annual Report and Form 10K for the year ended December 31, 2002, and VISX Form 10-Q for the quarter ended March 31, 2003, filed with the Securities and Exchange Commission. Forward-looking statements include statements regarding the Company's expectations, beliefs, intentions or strategies regarding the future and can be identified by forward-looking words such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "should," "will," and "would" or similar words. The Company assumes no obligation to update the information included in this press release, whether as a result of new information, future events or otherwise.
Editors' Note: VISX, VISX CustomVue, CustomVue, VISX WaveScan, and WaveScan are trademarks of VISX, Incorporated.