FDA approves IOL for cataracts and presbyopia

January 6, 2009

Alcon Inc. has received FDA approval for a lens designed for implantation during cataract surgery in patients with presbyopia (AcrySof IQ ReSTOR +3.0 D).

Huenenberg, Switzerland

-Alcon Inc. has received FDA approval for a lens designed for implantation during cataract surgery in patients with presbyopia (AcrySof IQ ReSTOR +3.0 D). The lens was introduced outside of the United States in 2008.

“The . . . IOL gives my patients a more comfortable reading distance, improved intermediate vision for tasks such as computer work, and excellent distance vision,” said one study investigator, Kerry Solomon, MD, who is professor of ophthalmology, Medical University of South Carolina, Charleston, and medical director, Storm Eye Institute, Mount Pleasant, SC.

The U.S. clinical trials included a 3-month follow-up exam of near, intermediate, and distance visual acuities. The percentage of patients in whom 20/20 or better vision was achieved at all three distances with the lens was nearly fourfold the rate of patients who received the control lens (AcrySof IQ ReSTOR +4.0 D), according to the company. The clinical studies also demonstrated a high rate of patient satisfaction, with more than 95% of patients stating that they would have the lens implanted again, Alcon relayed.

“Advanced-technology IOLs that correct for presbyopia and astigmatism are the fastest-growing IOL segment of cataract surgery,” said Kevin Buehler, senior vice president, global markets, and chief marketing officer, Alcon. “The addition of this new lens meets a growing desire on the part of cataract patients for spectacle independence after cataract surgery.”