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B&L receives FDA ‘approvable’ letter for customized ablation system

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Another wavefront-guided customized ablation system moved closer to commercialization last month. Bausch & Lomb confirmed that the Food and Drug Administration issued an approvable letter for its Zyoptix wavefront-guided ablation system in mid-August.

“We did get an approvable letter from the FDA on August 18,” Margaret A. Graham, director of corporate communications, told Ocular Surgery News. “We’re working on labeling with the FDA now, and we still believe we’re on schedule for a third quarter approval.”

Presuming the Zyoptix system is approved in the United States, it will bring to three the number of customized wavefront ablation systems currently available, following the Alcon LADARWave and Visx CustomVue systems.

Zyoptix is already being marketed in Europe, Asia, Latin America and Canada.