CustomVue LASIK Approved for Farsightedness and Farsighted Astigmatism

On December 15, 2004, VISX Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) to treat farsightedness (Hyperopia) and farsighted astigmatism with the VISX CustomVue (TM) Hyperopic LASIK procedure.



The FDA approval is specifically for the company's wavefront-guided LASIK procedure. The enhanced CustomVue (TM) procedure involves detailed WaveScan (R) measurements of the patient's vision problems. These wavefront-guided measurements help provide a more precise and customized vision correction treatment than a standard LASIK procedure.



The FDA approval covers treatments of up to 3.00 diopters (D) of hyperopia without astigmatism and up to 2.00 D of farsighted astigmatism. (The Spherical Equivalent of a hyperopic prescription with astigmatism must not exceed +3.00 D.)



With this approval, VISX's CustomVue (TM) procedure becomes the first wavefront-guided laser treatment for hyperopia in the United States.



Colman Kraff, M.D., principal investigator with the VISX (R) multi-center clinical study, states, "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 (TM) procedure for hyperopia when asked to compare it to their night vision with eyeglasses or contacts prior to the surgery. The VISX clinical study results also exceeded all of the FDA required parameters for safety and effectiveness.