First U.S. Custom Wavefront LASIK Approval for Farsightedness and Astigmatism

December 15, 2004

VISX announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to treat hyperopia (farsightedness) and hyperopic astigmatism with the VISX CustomVue Hyperopic LASIK procedure.

The FDA approval allows for WaveScan® diagnosis and CustomVue™ treatment of patients with farsightedness and astigmatism. This approval is specifically for wavefront-guided LASIK for correction of hyperopia with or without astigmatism up to +3.00D MRSE, with cylinder up to +2.00D.

The CustomVue procedure is the first U.S. approved wavefront-guided laser treatment for hyperopia.

Colman Kraff, M.D., principal investigator with the VISX® multi-center clinical study, stated, “VISX’s new CustomVue Hyperopia procedure is a significant step forward in the treatment of farsightedness. The overall quality of vision with this new procedure is so superior that I plan to treat all of my qualified patients with CustomVue Hyperopia.”

A six-month evaluation of clinical study participants showed that more than four times as many people were very satisfied with their night vision after the VISX CustomVue hyperopia procedure, compared to their night vision before with glasses or contacts. TheVISX clinical study results also exceeded all of the FDA required parameters for safety and effectiveness.

The Doheny Laser Vision Center performs the VISX CustomVue hyperopia LASIK procedure.