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VISX TWENTY/TWENTY EXCIMER LASER NEEDS ONE-YEAR FOLLOWUP DATA

This article was originally published in The Gray Sheet

Executive Summary

VISX TWENTY/TWENTY EXCIMER LASER NEEDS ONE-YEAR FOLLOWUP DATA to support approval of the device for phototherapeutic keratectomy, FDA's Ophthalmic Devices Advisory Panel concluded at a March 21 meeting in Bethesda, Maryland. As a condition of approval, the panel stipulated that Visx provide one-year followup data on safety, efficacy and stability. The same condition was specified for approval of Summit Technology's excimer laser, which was reviewed on the same day.
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