Full Press Release Details
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ALCON LEADS THE INDUSTRY WITH PMA
FILING FOR CUSTOM LASIK SURGERY
FORT WORTH, TEXAS - Alcon, Inc. (NYSE: ACL) announced today that the U.S.
Food and Drug Administration (FDA) has accepted its custom wavefront-guided
laser eye surgery Pre-Market Approval Application (PMA). As this is the first
filing accepted by FDA, it means Alcon is leading the industry in regulatory
review of custom laser surgery. The acceptance of this filing marks a
significant milestone in the FDA review process.
Alcon was the first company to initiate FDA clinical trials for custom
LASIK surgery using a wavefront measurement device and an excimer laser.
LADARWAVE(R) surgical system, Alcon's wavefront measurement device, measures the
optical aberrations of the entire eye. These measurements are used by Alcon's
LADARVISION(R) 4000 excimer laser to uniquely reshape the cornea. By design, the
LADARWAVE and LADARVISION 4000 work together to perform the precision ablations
required in custom laser surgery while tracking eye movements at 4,000 times per
"We are pleased to be first in the industry to be so far along in custom
wavefront-guided LASIK technology," said Bill Barton, VP and General Manager,
Surgical Division. "Custom LASIK surgery has the potential to improve visual
acuity and enhance overall vision quality as compared to today's conventional
LASIK surgery. Alcon is excited about the prospect to provide this technology to
its customers and to their patients."
Alcon, Inc. is the world's leading eye care company. Alcon, which has been
dedicated to the ophthalmic industry for more than 50 years, develops,
manufactures and markets pharmaceuticals, surgical equipment and devices,
contact lens solutions and other vision care products that treat diseases,
disorders and other conditions of the eye. The LADARVISION 4000 and other
refractive products are commercially available in the United States and
International markets.
CAUTION CONCERNING FORWARD-LOOKING STATEMENTS. This press release contains
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995, relating principally to the acceptance by the FDA
of our PMA and the expected benefits of custom wavefront-guided laser eye
surgery. These statements involve known and unknown risks, uncertainties and
other factors which may cause our actual results, performance or achievements to
be materially different from any future results, performances or achievements
expressed or implied by our forward-looking statements. These statements reflect
the views of our management as of the date of this press release with respect to
future events and are based on assumptions and subject to risks and
uncertainties. Given these uncertainties, you should not place undue reliance on
these forward-looking statements. Factors that might cause future results to
differ include, but are not limited to, the following: we may never gain FDA
approval of the PMA or approval of the PMA may take longer than we expect;
general economic conditions in the United States and internationally;
technological advances attained by our competitors; challenges inherent in new
product marketing; and government regulation and legislation. You should read
this press release with the understanding that our actual future results may be
materially different from what we expect. Except to the extent required under
the federal securities laws and the rules and regulations promulgated by the
Securities and Exchange Commission, we undertake no obligation to publicly
update or revise any of these forward-looking statements, whether to reflect new
information or future events or circumstances or otherwise.
For information, contact:
Doug MacHatton (Investor Relations)
News media inquiries: Mary Dulle (Corporate Communications)