WaveLight Receives Mixed Astigmatism Approval

Allegretto Wave excimer laser system is approved by FDA to correct challenging refractive error.

STERLING, Va.--(BUSINESS WIRE)--May 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