FDA Approves Vision-Fixing Procedure From VISX
VISX
(EYE) - Get Report
said the Food and Drug Administration has approved the CustomVue laser vision correction procedure, an announcement that helped lift the company's shares 5% in afternoon trading.
The CustomVue procedure creates an individualized correction plan for each patient. CustomVue uses what's called the VISX WaveScan System, a new diagnostic tool that captures a unique "fingerprint" of the eye.
The company made the announcement after the close Friday and said the system is 25 times more precise than what was previously measurable by standard methods. WaveScan captures specific imperfections in each person's vision, and the data is then used to generate a specific treatment for a CustomVue procedure.
VISX said the clinical study results that were the basis of the FDA approval exceeded all of the agency's required measurements for safe and effective laser vision correction. The FDA approval allows for WaveScan diagnosis and CustomVue treatment of patients with nearsightedness and astigmatism.
Shares of VISX were up 94 cents to $18 on more than four times normal volume.