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Two more LASIK systems gain FDA approval

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The Food and Drug Administration granted marketing approval to two refractive excimer laser systems, the makers of the systems announced. One system offers customized wavefront ablation, the other is a company's first foray into the U.S. marketplace.

According to Bausch & Lomb, the FDA approved its Technolas 217z Zyoptix system for the correction of myopia of up to 7 D with up to –3 D of astigmatism and with manifest refractive spherical equivalent of up to –7.5 D.

And WaveLight Laser Technologie AG announced that it received FDA premarket approval for its Allegretto Wave excimer laser system. This makes WaveLight the first European manufacturer of refractive laser equipment to gain U.S. regulatory approval, according to the company.

Bausch & Lomb announced that its FDA approval was based on results of a three-center U.S. clinical trial involving 340 eyes. In that study, 91.5% of patients achieved uncorrected visual acuity (UCVA) of 20/20 or better and 70.3% achieved UCVA of 20/16.

At 6 months follow-up, more than 94% of patients had maintained or improved upon their preoperative best corrected visual acuity (BCVA), B&L said.

Patient satisfaction was high in the B&L trial, with 99% of patients reporting satisfaction with results and no patients reporting dissatisfaction. Additionally, 99.7% of patients stated they experienced an improvement in quality of vision from preop, with more than 40% reporting improvement in night vision.

According to WaveLight, the FDA approved its Allegretto Wave for correction of myopia of up to 12 D with or without astigmatism of up to –6 D.

U.S. clinical trials of the WaveLight system had been ongoing for 3 years and involved 11 sites. A total of 901 eyes were treated, and 12-month follow-up was obtained for 813 of 866 eligible eyes.

At 3-month follow-up, 98% of 844 eyes had stable UCVA of 20/40 or better and 84.4% were at 20/20 or better, according to the company.

WaveLight had been preparing for the approval earlier this year. On July 31, it acquired 50% of WaveLight Laser Inc., which is the official representative of WaveLight Laser Technologie AG in the United States. The company will function as the official owner of all future U.S. approvals for the Allegretto Wave and will be responsible for sales and marketing activities.