Apodized diffractive IOL hits U.S. market

Fort Worth, TX-Alcon Inc. has launched what it calls the first and only IOL to use apodized diffractive technology to provide good vision range to cataract patients with and without presbyopia.

The AcrySof ReSTOR IOL, approved March 21 by the FDA, features a patented optic design that uses apodization, diffraction, and refraction to yield a high level of spectacle freedom. In clinical trials, 80% of patients reported never wearing reading glasses or bifocals following bilateral cataract surgery.

The foldable IOL does not rely on the age-weakened ciliary muscle to adjust the focus. Instead, it uses a controlled step height reduction combined with diffractive and refractive optics to optimize the light energy delivered to the retina by distributing the appropriate amounts of light to near and distant focal points, regardless of the lighting situation.

Meanwhile, Alcon said its phase III clinical data show its nepafenac 0.1% ophthalmic suspension (NEVANAC) is effective in controlling pain and postoperative inflammation associated with cataract surgery. Results were announced during the April annual meeting of the American Society of Cataract and Refractive Surgery in Washington, DC.

More than 80% of patients treated with the drug had no pain on day 1, compared with 40% to 50% in the placebo group, and by day 14, about 95% of patients treated with the drug were pain free, compared with 45% to 60% in the placebo group. Similarly, 85% of treated patients had no inflammation at day 14, compared with about 47% in the placebo group.

The FDA has accepted Alcon's new drug application for the suspension and is giving it priority review.

In other news, Alcon's chief executive officer, Cary Rayment, has been named chairman of the company's board of directors for a 3-year term. Rayment replaces Timothy R.G. Sear, who retired as a director and chairman of the board effective May 3.

Rayment was appointed CEO on Oct. 1 after serving as vice president, marketing, surgical products; vice president and general manager, surgical products; vice president, international marketing; and senior vice president. He joined the company in 1989.