STERLING, Va.--(BUSINESS WIRE)--May 3, 2006--WaveLight, Inc.
(FSX:WLT) today announced that it has received approval from the
U.S. Food and Drug Administration (FDA) to treat mixed astigmatism
with the wavefront-optimized(TM) ALLEGRETTO WAVE excimer laser system.
The indication includes the reduction or elimination of naturally
occurring mixed astigmatism of up to 6.00 diopters at the spectacle
plane.
The ALLEGRETTO WAVE is a wavefront-optimized excimer laser that
delivers specific ablation profiles based on each eye's unique corneal
asphericity. The wavefront-optimized algorithm is applied to all
ALLEGRETTO WAVE treatments, including mixed astigmatism.
The approval was based on study results of 162 eyes treated at
six investigational sites throughout the U.S. to evaluate the safety
and effectiveness of mixed astigmatism treatment with the ALLEGRETTO
WAVE.
Three month follow-up data reported for 142 eyes demonstrated
that 68 percent of eyes achieved 20/20 vision and 95.8 percent achieved
20/40 vision postoperatively. For sphere, 94 percent of eyes were
within 0.5 diopters of targeted correction and 99 percent of eyes
were within 1 diopter of targeted correction. Astigmatic results
for 77 percent of eyes were within .5 diopters of target and 95
percent of eyes were within 1 diopter of target. The overall average
for glare and night driving complaints improved for both symptoms,
according to a subjective survey.
"Our company mission at WaveLight is to expand continuously the
indications available for wavefront-optimized treatments, and thus
deliver superior clinical outcomes," stated Max Reindl, founder
of WaveLight AG. "This newest approval for the ALLEGRETTO WAVE met
all established FDA safety and efficacy targets and achieved similar
visual outcomes as we have seen with wavefront-guided treatments
for mixed astigmatism."
Study investigator, Michael Gordon, M.D., remarked, "Mixed astigmatism
is particularly challenging for doctors to treat because it requires
that both a myopic and hyperopic treatment be applied to the cornea,
often in two consecutive treatments. The new approval for the ALLEGRETTO
WAVE will enable ophthalmologists to provide one treatment while
conserving more corneal tissue in comparison to other available
approaches."
Mixed astigmatism or irregular astigmatism describes the unequal
curvature of the cornea in which one principal meridian is myopic
and the other is hyperopic. Mixed astigmatism causes distorted vision
at both near and far distances because of the way in which distortions
occur on different portions of the eye's surface.
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
