New labeling claims for Tecnis okayed by FDA

PEAPACK, N.J. — The Food and Drug Administration granted additional labeling claims to the Tecnis IOL, allowing its manufacturer to claim the IOL reduces spherical aberrations and improves performance on a night driving simulator. According to manufacturer, Pfizer Inc., the Tecnis is the first IOL allowed to make these claims.

“The ability of the Tecnis lens to improve functional vision sets a new standard in the treatment of cataract patients,” said Mark Packer, MD, one of the leading investigators of the lens.

According to a company press release, the Tecnis was specifically designed to improve the functional vision of patients after cataract surgery.

The FDA approved the new claims based on the results of a controlled, multicenter intra-individual trial in which one eye of each patient was implanted with a Tecnis IOL and one with a traditional acrylic IOL. Contrast sensitivity and postop spherical aberration were measured in 78 patients. A secondary objective was to demonstrate contrast sensitivity differences in the full study population and to perform postop spherical aberration measurements and test functional performance in a validated night driving simulator on 29 patients.

The contrast sensitivity results did not meet the primary study objective, according to the press release. The driving simulation study did meet its objective, and Tecnis eyes performed functionally better than control eyes in 21 of 24 conditions tested, the press release said.

Spherical aberrations were significantly less with the Tecnis lens than with the traditional lens with the spherical optic.

Earlier this week, Advanced Medical Optics and Pfizer announced that AMO will purchase Pfizer’s surgical ophthalmic business, which includes the Tecnis lens.

For more on the AMO/Pfizer deal, click here.