Photochromic IOL to be available in Europe

Irvine, CA-Medennium Inc. expects that its photochromic IOL (Aurium) will be available in all European countries by September now that it has obtained CE mark clearance to market the lens. It is the first and only photochromic IOL, according to the company.

"The idea for [the lens] is to provide additional protection for a cataract patient's retina without any compromises, such as night vision," said Stephen Zhou, PhD, vice president of research and development at Medennium.

The lens responds to changes in the environment, turning yellow when exposed to sunlight and becoming colorless indoors when no ultraviolet or blue light is present, he added.

She conducted the biocompatibility study for the lens in a rabbit model with Nick Mamalis, MD, director of the center's ophthalmic pathology laboratory.

Clinical data from two clinical sites were used to support the application for the CE mark. David Méndez, MD, director of the Instituto de la Visión, Mexicali, Mexico, implanted the lens unilaterally in 15 patients; a yellow control lens was implanted in the fellow eye. At 6 months, "all of my patients are doing very well," he said. "In addition, it appears that [eyes with the photochromic] lenses have a better best-corrected visual acuity in comparison [with eyes with] the control IOLs [implanted], especially under weak lighting conditions."