Artisan phakic IOL recommended for approval

GAITHERSBURG, Md. — The Artisan/Verisyse phakic IOL was recommended yesterday for approval, with conditions, by an advisory panel to the Food and Drug Administration, the companies marketing the lens announced.

Thursday’s recommendation from the FDA’s Ophthalmic Devices Panel was regarding Ophtec USA’s premarket approval application for its Artisan lens, which is already approved in Europe. Assuming FDA approval, Advanced Medical Optics will market the lens in the United States under the name Verisyse. Ophtec USA is a subsidiary of Ophtec BV, of the Netherlands, which distributes the lens under the Artisan name in Europe.

The panel reached its decision after much deliberation over the safety and efficacy data submitted by Ophtec USA and AMO. Much of the debate concerned the rate of endothelial cell loss with the lens, which attaches to the midperipheral iris and sits in the anterior chamber. Some panel members felt the sponsor's data was insufficient, in light of the worldwide acceptance and long record of experience with the lens.

There was also concern among panel members that patients with large pupils could be at risk for postoperative complications, although the company's data did not show problems. The lens is available with 5-mm and 6-mm optic diameters.

Most of the conditions can be met through labeling, according to the panel. For example, the panel recommended that the risks of extrapolation be cited, despite company data suggesting a low risk of complications.

Nicholas Tarantino, OD, vice president for AMO, told Ocular Surgery News he had expected the panel to approve the device. He said he understood the data was difficult for them but that they gave a rigorous review.

The lens is available in negative powers up to –15 D and –20 D, depending on the optic size. According to a joint statement from AMO and Ophtec, when the lens is made commercially available it will be in 0.5-D steps.

Other conditions recommended by the panel for Verisyse approval included an anterior chamber depth of more than 3.2 mm and a postmarket study.

The IOL “provides excellent refractive outcomes – 95% of study participants achieved manifest refraction spherical equivalents that were within 1 D of target,” said Doyle Stulting, MD, PhD, director of Emory University Eye Center’s corneal service, in the joint press release.

The final FDA decision is expected within the next 6 months, the companies noted in the press release. Although the FDA is not bound by the recommendations of its advisory panels, it typically follows their advice.