Hydroview packaging change given U.S. approval

CLAREMONT, Calif. — U.S. regulators have given pre-market approval to new packaging for Bausch & Lomb's Hydroview IOL. Bausch & Lomb executives say the new packaging will eliminate the small incidence of calcification phenomena seen with previous versions.

As originally approved, the Hydroview hydrophilic acrylic IOL was housed in a delivery system that contained silicone. The Food and Drug Administration (FDA) on Monday approved changing the packaging to one that contains non-silicone material.

Although not currently marketed in the United States, the Hydroview IOL has been available in other countries commercially since 1995, and surgeons have implanted about 600,000 lenses to date. Opacification attributed to calcification of the lens optic occurred in 34 of the 3,500 sites using the lens. Calcification was reported in 368 cases (0.06%), with 157 of these resulting in decreased visual acuity and explantation.

An "exhaustive study" of explanted lenses, clinical factors and a laboratory model of the calcification phenomenon convinced Bausch & Lomb managers the problem originated with the silicone in the gasket of the delivery system, said Brian Levy, OD, PhD, vice president of global clinical affairs for Bausch & Lomb.

"These laboratory models confirmed that changing the gasket to one that contains non-silicone material would resolve the phenomenon by removing the catalyst from the equation," he said.

Bausch & Lomb plans on introducing the Hydroview IOL in the U.S. market some time during the fourth quarter this year, and will be debuting the IOL to U.S. surgeons at the American Academy of Ophthalmology meeting later this week.

For more on the search for the cause of the Hydroview calcifications, see the article in the upcoming Nov. 15 issue of Ocular Surgery News.