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FDA panel recommends approving Visx excimer for astigmatism
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WASHINGTON — The Food and Drug Administration's (FDA's) Ophthalmic Devices Advisory Panel voted four to three to recommend approval of Visx's excimer laser system for photorefractive keratectomy for myopic astigmatism between 0.75 and 4 D.
The recommendation for approval comes with three conditions: the labeling will restrict the minimum patient age to 21, patients between 21 and 30 will be told of an increased incidence of glare and halos for that age group and Visx will train surgeons for astigmatic procedures.
The Visx system uses a software change in the keycard to create a radially asymmetric beam. Last month's split vote carries the recommendation to the FDA's Division of Ophthalmic Devices, which has final authority in approving the system.