Should the FDA go along with the panel, the Visian Toric device would be the only lens approved in the U.S. for placement in the posterior chamber of the phakic eye that uses both toric and phakic features to treat astigmatism and myopia. The watchdog agency is not bound by its advisory panel decisions, but often follows their lead.
Staar Surgical president & CEO Barry Caldwell told MassDevice.com this morning that the FDA’s time to approval after a panel vote for ophthalmic medical devices ranges between 6 weeks and 18 months.
"Obviously, we’d hope to be on the short end of that," Caldwell told us. "We’ll be very pleased to finally have the opportunity to commercialize this technology in the U.S."
Five of the FDA’s Ophthalmic Devices Panel members voted that there’s a reasonable assurance of safety, with 1 no and 3 abstentions. The vote on effectiveness went 7-1-1, and 6 panelists voted that the Visian Toric’s benefits outweigh its risks, with 3 abstentions. Although panelists cited severe flaws with the study for Visian Toric, they acknowledged the device would fill an unmet need for U.S. patients and noted that it is already available in other markets throughout the world.
"I voted yes on all 3, and I think with trepidation on all 3 because of the nature of the study, and that was my biggest concern was the way it was carried out," said Dr. Winston Chamberlain of Oregon Health & Science University’s Casey Eye Institute in Portland. "Hopefully the [post-approval study] will be carried out in a more reasonable fashion, along with some of the recommendations that were made today. I do believe that this technology has tremendous promise for certain individuals."
Dr. Jayne Weiss of LSU’s Health Science Center in New Orleans, who abstained on all 3 questions, underscored the panelists’ dilemma.
"I think the panel has been put in an impossible situation of voting for device approval that patients and M.D.s might want on the basis of a highly flawed study that cannot give us the answers to the questions we were asked," Wiess said.
"I’d like to see approval for patients in whom the benefits outweigh the risks, such as those patients who are higher myopes or maybe those who cannot have any other refractive procedures," Weiss added. "I would, though, ask the FDA and sponsor to consider developing a standard consent form for the potential candidates for this to ensure no patient is given unrealistic expectations that this is a trivial procedure and this is because I’m a veteran of the 2008 Lasik meeting in which this came up again and again."
Caldwell said that, because the Visian Toric study protocol dates back to the early 2000s, newer technologies developed since then weren’t allowed into the trial.
"Back in those days, toric [intra-ocular lenses] were very new to the market. Today, they’re not new at all," he said. "And there are newer technologies to help assist, but of course if you have a protocol established that long ago, you can’t use the new technologies. We’ve implanted over 110,000 of these toric ICLs around the world with very, very successful outcomes. The clinical outcomes are just outstanding."
Staar Surgical plans to keep a close eye on the roughly 9,000 patients who’ve had the device implanted for at least 15 years, Caldwell added.
"That’s where you really start to learn things or not learn things," he said. "There are 60-plus countries [where the Visian Toric is approved]. The U.S. is the last major market by far."
Regulatory history for Visian Toric
This is not Visian Toric’s 1st time at bat with the FDA, according to background materials released ahead of the meeting. The federal watchdog agency in 2012 denied marketing approval for the lens after Staar Surgical failed to meet requirements for post-approval study data. Visian Toric was initially approved in 2005, subject to post-approval study data from 3 studies.
The 1st post-approval study was to monitor for device-related corneal endothelial cell loss for 5 years and Staar was asked to provide yearly reports on this data. FDA in 2011 approved Staar’s report on the results of this study, but ultimately denied the company’s proposed device labeling revision in 2012 "based on a number of concerns regarding the analysis used to describe the endothelial cell density (ECD) development. The applicant has yet to provide FDA with their response to the labeling concerns," the agency stated.
Staar was also tasked with monitoring adverse events under conditions of general use in a second 5-year post-approval study of Visian Toric, including cataract formation, corneal decompensation, persistent elevated retinal detachment, chronic uveitis and secondary surgical interventions (e.g., lens exchange, lens explantation, repositioning). This 2nd study, which is ongoing, involved enrollment of 5,000 U.S. patients in order to obtain 5-year follow-up on at least 2,000 patients.
Finally the company was asked to conduct a pre- and post-operative axial length measurement sub-study to determine whether Visian Toric affects this measurement. The FDA in 2011 approved Staar Surgical’s proposed updates to device labeling based on this 3rd sub-study.
Panelists made some additional recommendations for post-approval study to supplement what Staar has proposed in the event that the FDA grants Visian Toric market approval for placement in the posterior chamber of the phakic eye to treat astigmatism.
Staar has proposed a multicenter (5-10 sites in the U.S.), single-arm, prospective post-approval study (PAS) in 150 patients to evaluate endothelial cell density loss and cataract formation over 5 years, refractive and visual outcomes in higher astigmatism groups over 1 year, and the stability of corrected cylinder and impact of visual disturbance over 1 year.
In addition, panelists asked that an active control arm be included comprised of concurrent patients who have not had surgical intervention within the same age range followed with the same techniques.
The panel also asked that the study be powered to detect significant differences in the proportion of eyes with large changes, less than 20% loss from baseline; that additional endpoints be included, such as pigment dispersion, angle, and transillumination defects; and that the sponsor employ some other method (such as a questionnaire or imaging) that ensures no rotation of the implant has occurred.
Visian Toric is already approved in a number of countries around the world, and Staar recently notched Japanese regulatory approval for a new version of the lens implant featuring CentraFLOW technology, which the company called a "key driver to our growth of Visian ICL revenues the past several quarters." CentraFLOW allows physicians to treat a larger range of patients with the Visian ICL, expanding to myopia starting at -3.0 diopters, up from the current range at -5.0 diopters, according to a press release.
STAA shares were trading at $17.92 apiece today as of about 11 a.m., up 16.6%.
Brad Perriello contributed to this report.
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