ALISO VIEJO, Calif.— Bausch + Lomb, announced the U.S. Food and Drug Administration (FDA) has approved its enVista hydrophobic acrylic intraocular lens (IOL). According to Bausch + Lomb, the enVista lens represents a significant step forward in IOL technology as it is the first and only FDA-approved IOL in the U.S. with labeling that states: "No glistenings of any grade were reported for any subject at any visit in the clinical study."

"Based on my experience, the new enVista hydrophobic acrylic IOL is an exciting addition to our IOL choices, as it has been clinically-proven to be free of glistenings, a common issue observed in some other hydrophobic IOLs," said Louis D. "Skip" Nichamin, MD, medical director of the Laurel Eye Clinic and the Laurel Laser & Surgery Center and one of the principal investigators in the FDA IDE trial for enVista.

Glistenings are fluid-filled microvacuoles that can form within an IOL and are common in some hydrophobic acrylic IOLs. Literature reports indicate that glistenings may not only present an aesthetic issue post-surgery for surgeons, but they can impact visual function, including visual acuity and contrast sensitivity in patients, due to a portion of light coming into the eye being scattered.

"As our first entry into the hydrophobic acrylic market, which makes up a significant segment of the overall IOL market in the U.S., the approval of enVista represents a key milestone for Bausch + Lomb's Surgical business," said John Barr, executive vice president and global president, Bausch + Lomb Surgical. "We're happy to be the only company with the distinction of offering an IOL proven to be glistening-free."

The enVista lens received CE Mark approval in the European Union in September 2011 and is currently pending approvals worldwide. Full commercial release of the enVista IOL in the U.S. is planned upon FDA clearance of its supporting insertion system.