Vision-correcting devices maker Staar Surgical (NSDQ:STAA) is getting a little FDA love early next year in the form of a review meeting to discuss a PMA supplement for the device maker’s Toric ICL, part of its Visian line of intra-ocular implants.
California-based Staar has a Valentine’s Day appointment with the FDA, according to a company SEC filing. The meeting should get notice in the Federal Register next month, Staar said.
Staar’s implantable Collamer lenses are surgically placed between the iris and the natural lens of the eye in order to correct vision, with the new Toric ICL designed to also help patients with near-sightedness, far-sightedness and astigmatism. The device is not yet available in the U.S., and Staar has gone a couple of rounds with the FDA to answer agency questions.
President & CEO Barry Caldwell told investors during an October 2013 conference call that the company had undergone FDA inspection visits at sites in both the U.S. and Switzerland, where "key reviewers of the Toric ICL submission" were present.
The Toric device is already available in markets overseas, where the company estimates that it comprises about half of its sales compared with Staar’s standard myopic lenses. There may be a similar trend in the U.S., starting with an initial post-approval surge in sales, Caldwell said during the conference call.
"There is some pent-up demand out there and the early adoption might be higher than that and then it could level off," he said.