Sep 12 2007
Advanced Medical Optics, Inc., a global leader in ophthalmic surgical devices and eye care products, today announced the U.S. Food and Drug Administration (FDA) has approved the Advanced CustomVue(TM) Monovision procedure, the first wavefront-guided laser vision correction procedure for the visual correction of myopic (nearsighted) presbyopic patients, with and without astigmatism.
"This approval marks another industry first for AMO," said Jim Mazzo, AMO chairman, president and CEO. "The Advanced CustomVue(TM) Monovision procedure is the only FDA-approved wavefront-guided LASIK treatment for the correction of both near and distance vision of presbyopic patients."
Greek for "aging eye," presbyopia is part of the natural aging process and affects most people sometime in their 40s. The condition causes the lens of the eye to lose flexibility, gradually diminishing its ability to focus on objects up-close. An estimated 90 million people in the United States have presbyopia, and nearly a third of them could benefit from the Advanced CustomVue(TM) Monovision procedure.
The Advanced CustomVue(TM) Monovision treatment can improve both near and distance vision utilizing AMO's Advanced CustomVue(TM) LASIK technologies, including the Star S4 IR® excimer laser and the WaveScan Wavefront® and Iris Registration(TM) technologies, to first map, and then custom-correct nearsightedness in the dominant eye, and partially correct nearsightedness in the other eye. The procedure is individualized for the unique correction requirements of presbyopic patients with low to moderate myopia, with and without astigmatism. The result is a reduced dependency on reading glasses and contact lenses.
The term monovision refers to a common method of vision correction for the management of presbyopia. In monovision, the dominant eye is corrected for distance vision, and the other eye for near vision. The brain learns to distinguish which eye sees near and which sees far.
The FDA based its approval on clinical data from a multi-center clinical trial, involving 160 patients for up to two years.
"With the aging population, the number of patients requiring age-related vision correction will only grow," said Mazzo. "AMO is making LASIK a viable option for the presbyopic generation. This demonstrates our commitment to delivering the very best technology for our surgeons, and the very best outcomes for their patients of all ages."
With this FDA approval, AMO continues to be uniquely positioned to provide the broadest range of wavefront-guided treatments for any patient interested in laser vision correction and the Advanced CustomVue(TM) procedure. AMO expects the procedure to be widely available to U.S. LASIK patients before the end of 2007.
As a first-in-class technology, AMO will be conducting a short post-marketing surveillance study on the Advanced CustomVue(TM) Monovision treatment as part of its U.S. launch.