STERLING, Va.--(BUSINESS WIRE)--Aug. 28, 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.
“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.
WaveLight AG (ISIN DE 000 512 5603)
WaveLight AG, listed in Deutsche Borse AG’s Prime Standard since January 2003, develops, produces, and markets a high-quality, end-to-end product portfolio in the fields of ophthalmology and aesthetics. WaveLight’s market success is based on its innovative range of products that are the technology leaders in their areas of application and its broad-based sales network featuring both own sales channels and strategic partners. In the past fiscal year 2004/2005, WaveLight generated revenues of EUR 80.7 million and EBIT of EUR 8.8 million. Its average growth rate (CAGR) since 2000/2001 amounts to 35 percent for revenues and 63 percent for EBIT.
Further information on WaveLight is available at: www.wavelight.com.
All information is given and all assessments are made on the basis of extremely conscientious research. However, no guarantee is given with regard to the information or assessments published. No liability whatsoever is accepted. The above statements do not represent an invitation to buy or sell securities. All rights reserved.
Disclaimer for wavefront-guided treatment of Myopia:
a. Approval of the premarket approval application is for the WaveLight ALLEGRETTO WAVE® Excimer Laser System used in conjunction with the WaveLight ALLEGRO Analyzer. The device uses a 6.5 mm optical zone, a 9.0 mm ablation/treatment zone, and is indicated for wavefront-guided (WFG) laser assisted in situ keratomileusis (LASIK): 1) for the reduction or elimination of up to -7.00 diopters (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; 2) in patients who are 18 years of age or older; and 3) in 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.
b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, contact lenses, photorefractive keratectomy (PRK), traditional LASIK and other refractive surgeries.
c. Approval of the application is based on a randomized clinical trial in the United States with 374 eyes treated; 188 with Wavefront-Guided LASIK (Study Cohort) and 186 with Wavefront Optimized LASIK (Control Cohort). 178 of the Study Cohort and 180 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%.
d. The studies found that of the 180 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point in the Study Cohort, 100% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better without spectacles or contact lenses. In the Control Cohort, of the 176 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 100% were corrected to 20/40 or better, and 92.8% 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 in the Study Cohort: light sensitivity (37.2% at baseline versus 47.8% at 3 months) and visual fluctuations (13.8% at baseline versus 20.0% at 3 months). In the Control Cohort, halos (36.6% at baseline versus 45.4% at 3 months) and visual fluctuations (18.0% at baseline versus 21.9% at 3 months).
f. Long term risks of Wavefront-Guided LASIK for myopia with and without astigmatism beyond 6 months have not been studied.
g. Note that the complete name for this ophthalmic laser is “WaveLight ALLEGRETTO WAVE® Excimer Laser System used in conjunction with the WaveLight ALLEGRO Analyzer. The device uses a 6.5 mm optical zone, a 9.0 mm ablation/treatment zone, and is indicated for wavefront-guided (WFG) laser assisted in situ keratomileusis (LASIK): 1) for the reduction or elimination of up to -7.00 diopters (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; 2) in patients who are 18 years of age or older; and 3) in 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.”
Contact: WaveLight AG Katrin Teigeler, +49/9131/6186-217 Fax: +49/9131/6186-228 katrin.teigeler@wavelight.com or CoActive Public Relations Carmen Caricchio, 415-621-6626 Fax: 415-621-6636 carmen@coactivepr.com
Source: WaveLight
