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.
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.
Disclaimer for wavefront-guided treatment of Myopia:
a. Approval of the premarket approval application is for the WaveLight
Allegretto Wave(R) 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(R) 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."
Further information on WaveLight is available at: www.wavelight.com.
