Bausch and Lomb's enVista achieves US regulatory milestone
28 June 2012 16:16 in Medical Company Product News
Bausch and Lomb has achieved a key US regulatory milestone for enVista, its hydrophobic acrylic intraocular lens (IOL).
The lens has become the first and only IOL to be approved by the US Food and Drug Administration that has been shown to deliver glistening-free performance in clinical trials.
Glistenings are fluid-filled microvacuoles that form within the lens and are common among many hydrophobic acrylic IOLs, creating aesthetic problems and impairing vision.
It is the latest regulatory hurdle to be cleared by enVista, which received CE Mark approval in Europe in September 2011 and is currently pending other approvals worldwide.
John Barr, executive vice-president and global president for Bausch and Lomb Surgical, said: "We're happy to be the only company with the distinction of offering an IOL proven to be glistening-free."
This comes after the company completed its acquisition of Ista Pharmaceuticals, a healthcare company specialising in ophthalmology products, earlier this month.
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