Sterling, VA, January 18, 2005. In a recent statement issued by the Eye Surgery Education Council of the American Society of Cataract and Refractive Surgery (ASCRS) Foundation, wavefront-optimized LASIK has been defined as a laser-based procedure with built-in corrections for spherical aberration. WaveLight Laser Technologie AG is the only laser manufacturer in the United States to incorporate wavefront principles into every treatment performed with its excimer laser system to address these optical disorders.

According to ASCRS, spherical aberration is a common problem for patients that can cause glare and lack of sharpness of vision, particularly under dim light conditions. Until the introduction of the ALLEGRETTO WAVE, only wavefront-guided technology could address these issues. The wavefront-optimized ALLEGRETTO WAVE is the only system with built-in software to minimize spherical aberrations during the standard LASIK treatment.

"The WaveLight ALLEGRETTO WAVE laser, using a wavefront-opimized algorithm, has improved my standard LASIK results in terms of both quality of vision and enhancements," said Michael Gordon, M.D., partner at Gordon Binder and Weiss Vision Institute, "Furthermore, my experience shows that these results are objectively and subjectively comparable to wavefront-guided treatments in every aspect."

In its statement, the ASCRS provided clarification on the refractive industry terms, "wavefront-guided" and "wavefront-optimized." Whereas wavefront-guided treatments create a unique treatment pattern based on the patient's entire aberrations (identified through diagnostic analysis), wavefront optimized treatment addresses spherical aberrations, through built-in software enhancements. While the Eye Surgery Council did not comment on the efficacy of either treatment method, it indicated that wavefront guided treatments are more time consuming.

"We are pleased the Council has issued a clarification on today's wavefront-based treatment methods and we are committed to educating the market about the ALLEGRETTO WAVE alternative to wavefront-guided treatment" said Wade Tetsuka, President of WaveLight, Inc. the US subsidiary of WaveLight Laser Technologie AG, "The laser's faster treatment times, increased patient comfort and quality of vision results account for the incredible demand we are experiencing in the marketplace. In just five years, WaveLight has sold more than 450 ALLEGRETTO WAVE systems worldwide and has gained more than 20 percent of all new U.S. laser sales in just one year,¹. In addition, physician users are reporting very high predictability of outcomes with enhancement rates of less than three percent²."

The ALLEGRETTO WAVE was the first refractive laser to receive concurrent approvals for the treatment of myopia up to –12 diopters with astigmatism of up to –6 diopters and hyperopia up to +6 diopters with astigmatism of up to +5 diopters, not exceeding a mean spherical equivalent of +6 diopters. In October 2004 WaveLight announced the beginning of its clinical trials for mixed astigmatism treatments and wavefront guided LASIK.

WaveLight Laser Technologie AG, listed in Deutsche Börse AG's Prime Standard since January 2003, develops, produces, and markets laser systems in the fields of ophthalmology, aesthetics, urology, and industrial applications. WaveLight's market success is based on its innovative laser systems that are the technology leaders in their areas of application and its broad-based sales network featuring both own sales channels and strategic partners. The Erlangen-based group broke even just five years after its formation in 1996. In the past fiscal year 2003/2004, WaveLight generated revenues of €62 million and EBIT of €6.2 million.

Further information on WaveLight is available at: www.allegrettowave.com

Press Contacts:
Wade Tetsuka
WaveLight Inc.
Tel: + 1 800 WAVELIGHT
e-mail: tetsuka@wavelight-laser.com

Katrin Teigeler
WaveLight Laser Technologie AG
Tel: +49/9131/6186-217
e-mail: teigeler@wavelight-laser.com

¹ based on Market Scope data (an independent research company) ² Gordon, M. (2004) New Technology Reduces Enhancement Rates. In Factors for Successful Conversion to new Excimer Technology. Review of Ophthalmology: p.4-5

a. Approval of the premarket approval application is for the WaveLight ALLEGRETTO WAVE™ Excimer Laser System to perform LASIK treatments in patients 18 years of age or older for the reduction or elimination of myopic refractive errors up to –12.0 diopters (D) of sphere with and without astigmatic refractive errors up to -6.0 D; and in patients with documented evidence of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery.

b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries.

c. Approval of the application is based on clinical trials in the United States with 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%.

d. The studies found that of the 844 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 98.0% were corrected to 20/40 or better, and 84.4 % were corrected to 20/20 or better without spectacles or contact lenses.

e. The clinical trials showed that the following subjective patient adverse events were reported as "moderate to severe" at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: visual fluctuations (12.8% at baseline versus 28.6% at 3 months).

f. Long term risks of LASIK for myopia with and without astigmatism beyond 12 months have not been studied.

g. Note that the complete name for this ophthalmic laser is "WaveLight ALLEGRETTO WAVE™ Excimer Laser System for laser assisted in situ keratomileusis (LASIK) treatments of myopic refractive errors up to –12.0 diopters (D) of sphere with and without astigmatic refractive errors up to –6.0 D at the spectacle plane".

a. Approval of the premarket approval application is for the WaveLight ALLEGRETTO WAVE™ Excimer Laser System to perform LASIK treatments in patients 18 years of age or older for the reduction or elimination of hyperopic refractive errors up to +6.0 diopters (D) of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D; and in patients with documented evidence of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia.

b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries.

c. Approval of the application is based on clinical trials in the United States with 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%.

d. The studies found that of the 212 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 67.5 % were corrected to 20/20 or better without spectacles or contact lenses.

e. The study showed that the following subjective patient adverse events were reported as "much worse" by at least 1% of the subjects (in order of increasing frequency) at 6 months post final treatment: glare from bright lights (3%); night driving glare (4.2%); light sensitivity (4.9%); visual fluctuations (6.1%); and halos (6.4%).

f. Long term risks of LASIK for hyperopia with and without astigmatism beyond 12 months have not been studied.

g. Note that the complete name for this ophthalmic laser is "WaveLight ALLEGRETTO WAVE™ Excimer Laser System for laser assisted in situ keratomileusis (LASIK) treatments of hyperopic refractive errors up to +6.0 diopters (D) of with and without astigmatic refractive errors up to 5.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D".

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