This excerpt taken from the EYE 8-K filed Aug 2, 2007.
AMO began shipments this week of a Complete®-branded multipurpose solution that it expects will be available to U.S. and European practitioners and patients in late August, marking the companys re-entry into the multipurpose market following the May recall. The company had originally expected to re-enter the market by the end of September. AMO will focus on disinfection efficacy and comfort, and promote a standard of care that emphasizes the importance of a rub-and-rinse regimen, per recommendations by professional eye care associations. AMO expects to begin shipments to other markets by the end of September.
In July, AMO received U.S. Food and Drug Administration (FDA) approval for the Advanced CustomVueTM Monovision procedure for the visual correction of myopic (nearsighted) presbyopic patients, with and without astigmatism. The approval marked an industry first as the Advanced CustomVueTM Monovision procedure is the only FDA-approved wavefront-guided LASIK treatment for the correction of both near and far vision in presbyopic patients. In a clinical trial, 96 percent of patients achieved 20/25 or better vision at both far and near after one year. AMO expects the procedure to be available to U.S. LASIK patients by the end of 2007.
In April, AMO introduced the White Star SignatureTM phacoemulsification system with FusionTM Fluidics. This new, advanced technology combines the proven performance of AMOs WhiteStar® technology with the safety of a revolutionary FusionTM dual pump fluidic system. A streamlined user interface and easy-to-use accessories enhance efficiency of the operating room environment. Commercial release of the WhiteStar SignatureTM system begins in August 2007.
Also in April, AMO received CE Mark for the commercial sale of its next-generation Tecnis® monofocal IOL in European Union member countries. It is designed to deliver ease-of-implantation with outstanding visual performance. AMO expects to launch this new IOL at the European Society of Cataract and Refractive Surgeons (ESCRS) meeting next month.