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VISX files more laser data and hopes for October review

This article was originally published in Clinica

Executive Summary

VISX has filed additional data with the FDA on photorefractive keratectomy performed on some 2,000 eyes using its excimer laser system. The submission is in response to concerns raised by the FDA Ophthalmic Devices Advisory Panel meeting in October 1994 about the optimal ablation on 6 mm zones (see Clinica No 627, p 22). VISX says it is the only US company to have followed a statistically significant number of such patients for over two years.

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