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WaveLight receives FDA approval for latest wavefront-optimized laser system
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STERLING, Va. — The Food and Drug Administration had granted U.S. marketing approval to WaveLight Inc. for its latest-generation wavefront-optimized excimer laser system, the company announced in a press release.
The approval covers the 400 Hz Allegretto Wave excimer laser for use in LASIK to correct myopia up to –12 D with up to –6 D of astigmatism, as well as for hyperopic corrections up to 6 D with up to 5 D of astigmatism, according to the release.
The FDA based the approval for myopic indications on data from U.S. clinical trials involving 901 eyes. At 3 months, stability analysis for 844 eligible eyes showed 98% achieved an uncorrected visual acuity (UCVA) of 20/40 or better, and 84.4% achieved 20/20 or better.
The hyperopia treatment indications were based on data for 290 eyes. At 6 months, stability analysis for 212 eligible eyes showed 95.3% achieved an UCVA of 20/40 or better, and 67.5% achieved 20/20 or better.
The 400 Hz repetition rate allows the Allegretto Wave to deliver 1 D of correction in 2 seconds with a 6.5-mm optical zone, according to the release. The reduced treatment time allows for shorter, more comfortable procedures and may be particularly beneficial for treating high myopia, high astigmatism or other time-intensive procedures, company officials noted.