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New laser vision correction procedure is approved by US FDA

Advanced Medical Optics : 20 August, 2007  (New Product)
Advanced Medical Optics has announced that the US Food and Drug Administration (FDA) has approved the company’s Advanced CustomVue Monovision procedure.
The procedure is the first wavefront-guided laser vision correction technique 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 Monovision procedure is the only FDA-approved wavefront-guided LASIK treatment for the correction of both near and distance vision of presbyopic patients.'

An estimated 90 million people in the USA have presbyopia, and nearly a third of them could benefit from the Advanced CustomVue Monovision procedure.

The Advanced CustomVue Monovision treatment can improve both near and distance vision utilising AMO's Advanced CustomVue LASIK technologies, including the Star S4 IR excimer laser and the WaveScan Wavefront and Iris Registration technologies, to first map, and then custom-correct nearsightedness in the dominant eye, and partially correct nearsightedness in the other eye.

The procedure is individualised 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-centre clinical trial, involving 160 patients for up to two years.

According to the clinical trial results, six months after being treated with the Advanced CustomVue Monovision procedure:

- 100 percent of patients achieved 20/40 or better vision at both distance and near.

- 100 percent of patients achieved binocular uncorrected near-vision of 20/40 or better.

- 100 percent of patients achieved binocular uncorrected distance-vision of 20/40 or better.

- More than 96 percent of patients decreased their use of corrective lenses.

After 12 months:

- When asked if they would have the Advanced CustomVue Monovision procedure again, more than 98 percent of patients said they would.

- More than 88 percent of patients achieved 20/20 or better uncorrected intermediate-vision.

- 100 percent of patients achieved 20/32 or better uncorrected intermediate-vision.

'With the ageing 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 positioned to provide the broadest range of wavefront-guided treatments for any patient interested in laser vision correction and the Advanced CustomVue procedure.

AMO expects the procedure to be widely available to US 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 Monovision treatment as part of its US launch.
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