A Medical Device Daily

VISX (Santa Clara, California) reported that it has received approval from the FDA to market and sell CustomVue treatments for mixed astigmatism.

With this CustomVue approval, VISX said it now "leads the industry" in wavefront-guided treatment for all forms of astigmatism, including nearsightedness with astigmatism, farsightedness with astigmatism and mixed astigmatism.

"VISX is now the only U.S. provider of a wavefront-driven treatment for all forms of astigmatism," said Liz Davila, VISX chairman and CEO.

Douglas Koch, MD, of Baylor Vision at Baylor College of Medicine (Houston) and a principal investigator for the VISX mixed astigmatism clinical trial, said, "CustomVue has provided far better quality of vision than the excellent results we were getting with the standard procedure. Mixed astigmatism patients are especially challenging for ophthalmologists because their vision is often difficult to correct with glasses and contacts. The CustomVue treatment may give these patients the opportunity to see better than they could ever see with glasses or contacts."

VISX is in the process of being acquired by Advanced Medical Optics (AMO; Santa Ana, California), a maker of eye care products and optical surgical equipment, in a cash-and-stock deal valued at about $1.27 billion (Medical Device Daily, Nov. 11, 2004). The companies reported in February that the deal, which was first disclosed last year, is expected to be completed a quarter later than originally planned, from 1Q05 to 2Q05.

The companies said they are awaiting completion of their respective year-end audited financial statements, prior to scheduling their respective stockholder meetings and mailing a joint proxy statement/prospectus to stockholders.

VISX is a maker of laser vision correction systems. It says that ophthalmologists have performed more than 6 million procedures worldwide using its systems.