Allegretto Lasik Laser System Receives FDA Wavefront-Guided Approval 

Wavefront-guided and wavefront optimized treatments demonstrate equivalence in clinical trials.

STERLING, Va.--(BUSINESS WIRE)--Aug. 2006--The US Food and Drug Administration (FDA) has approved WaveLight's wavefront-guided procedure, a LASIK treatment approach that combines the Allegro Analyzer with the 200 hertz Allegretto Wave excimer laser. WaveLight now offers US physicians the choice of Wavefront Optimized and wavefront-guided LASIK treatment options, both of which demonstrated similar outcomes in clinical studies.

A wavefront-guided excimer laser uses an evaluation unique to each eye to determine the best laser treatment plan for an individual patient. A wavefront-optimized laser uses wavefront data derived in the laboratory to determine the best overall tissue ablation plan. Other wavefront-guided lasers approved in the US are the Alcon LADARVision CustomCornea, AMO Visx S4 CustomVue , and the Bausch & Lomb Technolas 217z Zyoptix.

"We are pleased that in addition to receiving mixed astigmatism approval last May, the Allegretto Wave has been granted yet another important FDA approval," said Max Reindl, chief executive officer of WaveLight AG. "WaveLight's philosophy is to provide physicians with the technology to achieve superior outcomes, whether they choose to perform Wavefront Optimized or wavefront-guided treatments. Because we are confident that both options will provide excellent outcomes, WaveLight will not increase the procedure fee for wavefront-guided treatments with the 200 Hz Allegretto Wave."

The Allegretto Wave wavefront-guided LASIK procedure was approved by the FDA for the reduction or elimination of up to -7.00 D of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane. The procedure may be performed on patients who are 18 years of age or older and on patients with documentation of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery. The refractive surgeon will also have the ability to adjust the spherical correction performed by +/- 3.00 D.

Wavefront Optimized LASIK is designed to treat spherocylinder errors without affecting higher order aberrations, especially spherical aberration. Wavefront-guided LASIK is based on aberrometry measurements and is designed to treat both spherocylinder and higher order aberrations.

The randomized clinical study of 374 eyes treated at five US centers validated that patients enrolled in either the wavefront-guided treatment group as well as the Wavefront Optimized group achieved similar visual results for uncorrected visual acuity (UCVA), manifest refractive spheroequivalent (MRSE) and postoperative UCVA versus preoperative best spectacle visual acuity (BSCVA). Myopic patients (up to +7D with up to +3D of astigmatism) were eligible to participate in the study.

At six-months, 93 percent of patients in both study groups achieved 100 percent vision or better. 85 percent of eyes in the Wavefront Optimized cohort and 87 percent of eyes in the wavefront-guided cohort achieved postoperative UCVA as good as or better than their preoperative BSCVA. At three months, all patients in both study groups were able to drive without glasses after treatment.

Results demonstrated similar wavefront outcomes in both groups in eyes with less than 0.3 microns of pre-operative higher-order aberrations (HOAs), accounting for 83 percent of eyes. Eyes with 0.3 to 0.4 microns of pre-operative HOAs demonstrated slightly more improvement with wavefront-guided treatments than with Wavefront Optimized treatments. In cases with more than 0.4 microns of HOA, it was discovered that post-operative HOAs were reduced significantly in the wavefront-guided cohort. No symptomatic increases in aberrations were observed in either cohort. Also, the Allegretto Wave is the only standard LASIK platform that has demonstrated the ability to preserve and improve low contrast acuity.

WaveLight's clinical investigator group included Stephen Brint, M.D., F.A.C.S., Michael Gordon, M.D., Karl Stonecipher, M.D., Bennett Chotiner, M.D., F.A.C.S., David Dulaney, M.D. and Charles R. Moore, M.D., F.I.C.S. The study was administered by SurgiVision Regulatory Consultants, Inc. of Scottsdale, AZ.

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. The Allegretto Wave received mixed astigmatism approval in May 2006 for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 diopters at the spectacle plane.

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