FDA requests more information from STAAR regarding toric ICL

Monrovia, CA-The FDA Office of Device Evaluation has requested that STAAR Surgical Co. amend its submission for approval of its Visian TICL (toric implantable Collamer lens) to enable the agency to complete its review of the lens’ safety and effectiveness. The FDA indicated Nov. 20 that its evaluation of the amendment could extend the review period by up to 180 days after the information is submitted.

According to David Bailey, chief executive officer of STAAR Surgical, the agency has requested additional data regarding a transitory rise in the rate of excessive ICL vaulting that the company reported earlier this year.

“We believe that this resulted from the learning curve of our surgeons in measuring and assessing key variables and would point out that over the last 4 months, the free sale rate of occurrence of excessive vaulting has been well below the 0.6% rate reported during U.S. clinical trials,” he said.

“We are pleased with this data point along with other longer-term follow-up from the U.S. clinical trial, where the cohort of 526 eyes now includes follow-up on 73% at 4 years or later and 59% at 5 years or later,” Bailey said. “Data from this gold-standard trial serve only to increase our confidence in the long-term safety of the Visian ICL device.”

The company submitted the original application on April 28 as a supplement to the pre-market approval application for its Visian ICL, which the FDA approved in December 2005 for use in correction of myopia in adults and which is now available in the United States. The submission initially was delayed to allow for an astigmatism analysis based on a scientific paper of the American National Standards Institute Subcommittee on Astigmatism written by FDA staff, ophthalmologists, and industry representatives.

In November at the American Academy of Ophthalmology annual meeting, the company reported long-term trends on two key safety variables: cataracts and endothelial cell counts. Clinically significant anterior subcapsular cataracts were observed in a cumulative total of 1.3% of cases, and no other types of cataract have been observed since the pre-market approval application was submitted, Bailey said.

“Cumulative endothelial cell loss at 5 years postoperatively was 12.5%, and cell morphology was most consistent with corneal endothelial remodeling with early stabilization and not chronic endothelial cell loss,” he added.

The Visian TICL, sold outside of the United States for the correction of astigmatism, is a refractive phakic implant intended for placement in the posterior chamber of the eye. The supplemental filing supports an indication for the correction of myopia and astigmatism in adults with myopia ranging from –3.0 to ≤ –20.0 D, with astigmatism ranging from 1 to 4 D at the spectacle plane, with anterior chamber depth 3 mm or greater, and with a stable refractive history within 0.5 D for 1 year prior to implantation.

STAAR Surgical has launched a Web site to provide physicians and consumers with additional information about the lens. The site, which is accessible at http://www.visianinfo.com or http://www.seebeyondlasik.com, contains clinical data, educational video, and surgical animations of the ICL procedure to help visitors compare the lens against competing technology. Physicians certified to perform the ICL procedure also are listed.