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STAAR ICL gets FDA panel recommendation with conditions
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GAITHERSBURG, Md. — The Implantable Contact Lens from STAAR Surgical received recommendation for premarket approval with conditions from a government advisory panel on Friday.
The Food and Drug Administration’s Ophthalmic Devices Panel voted 8 to 3 to recommend approval of the ICL, with conditions, for correction of myopia in the range of –3 D to –15 D and for reduction of myopia from –15 D to –20 D. The conditions primarily include postmarket surveillance and labeling issues.
“We are extremely pleased with the panel’s recommendation and vote of confidence and look forward to working with the FDA staff to complete the review of the ICL,” said STAAR president and chief executive officer David Bailey in a company press release.
While the data presented to the FDA by the manufacturer showed the lens to meet safety and efficacy standards with a low rate of complications, the panel was divided over the indications and safety of the device in a young population. Specifically, panel members voiced concerns about potential endothelial cell loss with the lens in the long term.
The panel’s recommendations were based on 3-year follow-up data from clinical trials. The panel recommended that STAAR provide postmarket follow-up data on its cohort patients for an additional year.
A STAAR scientific officer said that the company would be “providing a steady stream of information” to the FDA regarding endothelial cell stability.
The panel also recommended that the company initiate a surgeon training program, consider changing the name of the device and alter the patient satisfaction questionnaire to better measure patient perception of the device.
The ICL has received the CE Mark in Europe and is approved for sale in 37 countries, according to STAAR.