Foldable lens receives NTIOL status for significant reduction in spherical aberration

Advanced Medical Optics (AMO) Inc.'s Tecnis foldable IOL has earned the title of New Technology IOL (NTIOL) from the Centers for Medicare and Medicaid Services (CMS). The designation follows labeling claims approved by the FDA in April 2004 that the lens reduced postoperative spherical aberrations compared with lenses with spherical optics and improved night driving simulator performance. The designation was effective Feb. 27.

"CMS approves AMO's claims of clinical advantages and superiority of the Tecnis IOL for ocular spherical aberrations and simulated night driving," CMS stated in the final notice published in the Jan. 27 Federal Register. "We find the AMO Tecnis lenses models Z9000, Z9001, and ZA9003 meet the NTIOL definition and are to be given the new NTIOL classification of Reduced Spherical Aberration."

A lens is identified as an NTIOL if the FDA has approved its labeling and advertising of specific clinical advantages over existing IOLs. To earn the classification, the lenses must offer reduced risk of intraoperative or postoperative complication or trauma, accelerated postoperative recovery, reduced induced astigmatism, improved postoperative visual acuity, more stable postoperative vision, or other comparable clinical advantages.

The new designation covers the Z9000 and Z9001 silicone models and the ZA9003 acrylic model.

June R. Cassell, director, AMO IOL marketing, Americas region, said the FDA had approved the labeling claims in 2004, but that CMS had requested additional studies before bestowing the NTIOL designation.

"It's not an easy hurdle to get over," Cassell added.

Although many doctors have had time to examine and use the Tecnis lens since the FDA approved labeling claims in April 2004, the designation offers AMO a new bragging point.

"For us, it's one more point of clinical validation of the superiority of this lens compared with standard IOLs," Cassell said. "This is just one more proved source from a completely neutral third party that looked at the data and realized it does offer a benefit."

The new classification means Medicare will reimburse ambulatory surgical centers an additional $50 for the lens, which generally costs 66% more than AMO's other lenses because of increased development expenses, Cassell said. Some of those expenses included a driving simulation study in which researchers found patients with the Tecnis lens in one eye-and a monofocal lens in the other-were able to identify a pedestrian hazard 45 feet sooner using the Tecnis lens (while covering the monofocal eye) than they were with the monofocal lens (and covering the Tecnis eye), she said.

Eleven doctors told CMS the lens helps improve safety and functional vision for patients, especially in low-light situations, according to the final notice published in the Federal Register. They cited improved contrast vision, reduced overall ocular spherical aberration, improved functional vision, and significantly better contrast sensitivity and contrast acuity.

Mark Packer, MD, clinical assistant professor of ophthalmology at the Oregon Health Sciences University in Portland and clinical study investigator for several Tecnis IOL studies-including the driving simulation study-agreed the IOL is unique.

"The Tecnis lens is the only IOL available that was specifically designed, based on wavefront measurements of a representative sample of the population, to compensate fully for the spherical aberration of the cornea," he said in an AMO news release. Michael Colvard, MD, an eye surgeon in Encino, CA, with a specialty interest in IOL technology and cataract surgery, called the Tecnis IOL "one of the few truly major advances in intraocular lens technology over the past 2 decades."

Several doctors advocated giving NTIOL status because of its aspheric optics. However, CMS said in its final notice that it lacked clinical data for that outcome.

"We recommend that the commenter who claimed that one of its IOLs has aspheric optic design characteristics submit an application with evidence showing clinical benefits of its lenses during the 2006 NTIOL application period," CMS wrote.