Blade-Free IntraLase Laser Removes LASIK Fear Factor, Helps Contribute to Rebound in U.S. LASIK Market.

IRVINE, Calif. & NEW ORLEANS -- The first laser to replace the hand-held blade historically used in LASIK (laser-assisted in-situ keratomileusis) is giving thousands of consumers each month the confidence to finally undergo this vision correction procedure. Many say they've been waiting years for LASIK technologies to improve and, specifically, for the blade to go away. Market data show growing consumer demand for the IntraLase(R) technology (IntraLase Corp.)(NASDAQ:ILSE) is helping contribute to an increase in LASIK volume. According to research firm Market Scope's data, the U.S. LASIK market is up 16 percent this year, representing a rebound to its 2000 peak.

IntraLase, which gained nationwide distribution of its INTRALASE(R) FS (fem-to-second) laser in mid-2004, offers the first laser technology for the initial step of the LASIK procedure (creating the corneal flap). To date, ophthalmologists have performed more than 200,000 IntraLase-initiated LASIK procedures, with almost 90,000 laser flaps completed in the first half of 2004 alone, representing one of every seven LASIK procedures performed in the United States.

While LASIK has proven to be a successful and relatively safe procedure, it is the first step that has caused the majority of LASIK complications. Traditionally, the corneal flap was made using a hand-held device with an oscillating metal razor blade, called a microkeratome. This device has been a source of anxiety for patients and physicians alike.

"A blade is the last thing most people want near their eye, which is why many of the 55 million Americans estimated to be eligible for LASIK are still wearing glasses or contacts," said Michael Gordon, M.D., assistant clinical professor of ophthalmology, University of California, San Diego and medical director of the Gordon Binder Vision Institute. "IntraLase removes the LASIK fear factor by replacing the hand-held blade with the precision of a computer-guided laser."

With accuracy more than 100 times greater than the microkeratome, the IntraLase laser makes every LASIK procedure safer, and virtually eliminates the severe, sight-threatening complications sometimes seen with the hand-held blade. According to SM2 Consulting, when given a choice, 78 percent of patients choose IntraLase-initiated LASIK rather than the blade.

The IntraLase laser is the first LASIK advancement to improve upon the first-step of the nation's number-one elective procedure by eliminating the blade. Wavefront-guided and Custom LASIK technologies (which provide for three-dimensional measurements of the eye to allow for customized vision correction) focus on improving the second step: vision correction by an excimer laser.

"New technology, including the IntraLase laser and wavefront-guided LASIK, has helped reinvigorate the U.S. LASIK market," said David Harmon, Market Scope. "Lower LASIK complication rates reported by surgeons using the IntraLase technology are playing an important role in reducing patient fears about LASIK."

Clinical studies report that the IntraLase laser significantly decreases the occurrence of blade-related complications, including invasive corneal incisions, corneal abrasions, "button-hole" cuts and improperly formed flaps; and is dramatically less likely to produce overly thin flaps or extremely thick flaps, events which could lead to serious complications.

Better Vision with IntraLase

In addition to making LASIK safer, clinical studies confirm that patients see better with IntraLase-initiated LASIK than with bladed LASIK. Data from the largest prospective randomized study comparing the visual acuity achieved by IntraLase-initiated LASIK to that of a mechanical blade will be presented at the American Academy of Ophthalmology (AAO) joint meeting on Saturday, Oct. 23.

The study, "Randomized Prospective Clinical Study of LASIK Performed with Mechanical vs IntraLase FS Laser Keratome," followed 88 patients undergoing bilateral LASIK, each eye randomized for flap creation with IntraLase or the leading microkeratome. Patients in the first arm underwent Custom LASIK while those in the second received standard LASIK. The study concludes significant visual acuity improvements were demonstrated in the IntraLase-treated eyes. Additionally, results for eyes receiving standard LASIK with IntraLase outperformed those for eyes receiving Custom LASIK with a microkeratome. (Editor's Note: Full data cohort available upon request.) Additional data show:

--More patients achieved 20/20 or better vision with IntraLase-initiated LASIK.

--Patients who stated a preference preferred the post-operative vision of their IntraLase-treated eye 3-to-1 over their blade-treated eye.

--The IntraLase laser created fewer high- and low-order aberrations, which can affect quality of vision and be associated with night glare and halos.

Clinical data previously presented and published show:

--In several studies, standard tests performed to diagnose post-operative dry eye indicated lower rates of this side-effect among IntraLase-treated patients.

--IntraLase patients required fewer enhancement procedures (re-operations) following LASIK.

--The precise IntraLase flap significantly reduces the incidence of post-operative induced astigmatism as compared with microkeratome-created flaps.

"These outcomes are the clinically proven results of better corneal flap technology," said Daniel S. Durrie, M.D., associate clinical professor, University of Kansas, lead investigator and presenter at Saturday's joint session of the AAO. "The ability to create corneal flaps with consistent dimensions, specifically thickness, is critical to a successful LASIK outcome, and are factors unachievable with the blade."

How IntraLase Works

Unlike a microkeratome blade that cuts across the cornea to create the flap, the IntraLase laser creates the flap from below the surface using an "inside-out" process, virtually eliminating severe, sight-threatening blade-related complications as a result.

Pulsing at a speed of one-quadrillionth of a second, the ultra-fast IntraLase FS laser uses an infrared beam of laser light to separate tissue at the molecular level by precisely positioning a series of microscopic bubbles within the central layer of the cornea. Thousands of these tiny bubbles are then stacked along the edge of the flap up to the corneal surface to complete the flap. A computer interface allows the surgeon to pre-program flap specifications unique to the individual patient, including flap diameter, depth, width, side-cut architecture, hinge location, and beveled edge.

The IntraLase laser flap process from start to finish takes approximately 45 seconds. The surgeon then lifts the corneal flap to allow for vision treatment by an excimer laser. When complete, the laser flap's beveled edge allows for accurate repositioning.

IntraLase-initiated LASIK is now performed by the nation's leading LASIK surgeons and medical institutions in nearly all major U.S. markets. The cost for LASIK incorporating the IntraLase laser averages $2,100 per eye, compared to traditional LASIK with a microkeratome at $1,785 per eye.

About IntraLase Corp.

IntraLase Corp. (NASDAQ:ILSE) is an ophthalmic medical device company that designs, develops and markets an ultra-fast laser, related software and disposable devices used in creating the corneal flap, the first step in LASIK surgery. Its products improve the safety, precision and visual outcomes of LASIK by providing a blade-free, computer-controlled laser solution as an alternative to the hand-held, metal-bladed microkeratome traditionally used to create the corneal flap. Founded in 1997, IntraLase products are sold worldwide.

For more information on IntraLase or to find a doctor in your area please visit www.intralase.com or call 877-393-2020.

Statements contained in this press release that are not historical information are forward-looking statements as defined within the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by the use of words such as "believe," "expect," "anticipate," "intend," "plan," "estimate," "project," or words of similar meaning, or future or conditional verbs such as "will," "would," "should," "could," or "may." Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied. Those risks and uncertainties include, but are not limited to: the degree of continued acceptance of LASIK surgery; general economic conditions; changes in federal tax laws governing the ability of potential LASIK patients to use pre-tax dollars to pay for LASIK surgery; the scope of government regulation applicable to our products; the extent of adoption of our product offering by LASIK surgeons; patients' willingness to pay for LASIK surgery; our ability to compete against our competitors; the occurrence and outcome of product liability suits against us; our ability to adequately protect our intellectual property; whether we become subject to claims of infringement or misappropriation of the intellectual property rights of others; the continued availability of supplies from single-source suppliers and manufacturers of our key laser components; the ability of our managers, operations and facilities to manage our growth; the success of our expansion into markets outside the United States; whether we lose any of our key executives or fail to attract qualified personnel; or if our new products or applications fail to become commercially viable.

Certain of these risks and uncertainties, in addition to other risks, are more fully described in our final 424(b)(4) prospectus, as filed with the Securities and Exchange Commission on October 7, 2004.

These forward-looking statements are made only as of the date of this press release, and we assume no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.