FDA approves Allegretto laser for treatment of mixed astigmatism

The FDA approved WaveLight Inc.'s wavefront-optimized Allegretto Wave excimer laser system for the treatment of mixed astigmatism. The indication is to reduce or eliminate naturally occurring mixed astigmatism of up to 6 D at the spectacle plane.

A multicenter study of 162 eyes evaluated the safety and efficacy of mixed astigmatism treatment with this laser. At 3 months postop, 68% of 142 eyes achieved 20/20 vision and more than 95% achieved 20/40 vision, the company said in a prepared statement. Ninety-four percent of eyes were within 0.5 D of targeted sphere correction, and 99% of eyes were within 1 D of targeted correction. More than three-quarters of eyes were within 0.5 D of astigmatic target, and 95% were within 1 D of target.

In other news, the company celebrated its 10-year anniversary as a leading medical device manufacturer of laser systems for ophthalmology and aesthetic industries. During the past decade, the company has secured more than $100 million in market capitalization while establishing successful subsidiaries in the United States, Spain, and France.

WaveLight employs 350 people worldwide and is continuing to expand in the United States and Asia.