WaveLight Receives Wavefront-Guided and Mixed Astigmatism Approval for ALLEGRETTO WAVE® Eye-Q
- Full Range of LASIK Treatment Options Now Available With Fastest LASIK Platform Available in U.S. -
STERLING, Va.--(BUSINESS WIRE)--WaveLight, Inc. (FWB:WLT) announced today that the U.S. Food and Drug Administration (FDA) has approved wavefront-guided and mixed astigmatism indications for the ALLEGRETTO WAVE Eye-Q system. WaveLight’s second ALLEGRETTO WAVE system introduced in the U.S., the Eye-Q is the fastest laser vision correction platform available today.
“The latest Eye-Q wavefront approval is the fourth FDA approval for WaveLight in the past twelve months, and brings the approvals for the 400 Hertz Eye-Q laser in line with those for the 200 Hertz ALLEGRETTO”
“We are pleased to provide surgeons with an even broader set of treatment options for the Eye-Q system,” said Wolfgang Tolle, CEO of WaveLight, Inc. “In accordance with our clinical philosophy, WaveLight’s ALLEGRETTO WAVE technology delivers consistent and superior outcomes on all platforms with either our proprietary Wavefront Optimized™ or wavefront-guided treatment modalities. We offer these choices so that the physician may determine which treatment is best suited for each individual patient.”
The Eye-Q wavefront-guided LASIK procedure was approved by the FDA for the reduction or elimination of up to -7.00 diopters (D) of spherical equivalent of 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 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 procedure may also be performed with a custom offset of -3.00 to +1.00 D for sphere and -3.00 to 0.00 D for cylinder.
The Eye-Q mixed astigmatism procedure was approved by the FDA for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane in patients who are 21 years of age or older 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 latest Eye-Q wavefront approval is the fourth FDA approval for WaveLight in the past twelve months, and brings the approvals for the 400 Hertz Eye-Q laser in line with those for the 200 Hertz ALLEGRETTO," said Guy M. Kezirian, M.D., F.A.C.S., president and founder of SurgiVision® Regulatory Consultants, Inc. This is a very exciting development for American ophthalmology. We now have access to WaveLight's latest technologies, which were previously unavailable in the United States."
The 400 Hz ALLEGRETTO WAVE Eye-Q, approved in July 2006, corrects one D of nearsightedness or farsightedness in just two seconds. The reduction in treatment time results in a shorter, more comfortable procedure for the patient. It is particularly beneficial for treating high myopia, high astigmatism or other time-intensive procedures.
For a complete list of treatment disclosures, please visit www.wavelight.com/eyes.
WaveLight AG (ISIN DE 000 512 5603)
WaveLight AG has been listed on Deutsch Börse AG’s Prime Standard segment since January 2003: The company, which develops, manufactures and markets a full range of high-quality products for ophthalmology, specializes in vision optics. The market success of WaveLight is based on a dense sales network comprised of WaveLight’s own sales channels as well as the sales channels of strategic partners.
Further information on WaveLight is available at: www.wavelight.com.
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