Implantable contact lens maker Staar Surgical (NSDQ:STAA) said it earned Health Canada approval to sell its EVO Visian ICL in the country.
The device to correct myopia and astigmatism is permanently implanted between the iris and the eye’s natural lens. Staar sells 3 implantable lenses under its Visian franchise, but none are available in the U.S., according to the company’s website.
“We are very pleased with Health Canada’s approval that allows us to offer the EVO ICL for myopia, with a broad power range of -3.0 to -18.0 diopters, to our surgeons and their patients in Canada. This represents an important new treatment option for eligible patients between 21 and 45 years old living with nearsightedness. This approval reinforces our deep commitment to patients seeking visual freedom, as we continue to build our growing EVO ICL portfolio. Staar looks forward to bringing this visual freedom choice to the Canadian refractive surgery market,” CEO Caren Mason said in prepared remarks.
The good news wasn’t enough to prevent Monrovia, Calif.-based Staar’s stock from falling to a 52-week low yesterday; STAA shares closed down -5.5% at $5.12 apiece yesterday.
The company last week reported a net loss of -$8 million for the 1st quarter of 2016, compared with a net loss of -$2.3 million in the 1st quarter of 2015. Net sales rose 2% year-over-year to $19.3 million.
U.S. intraocular lens revenues fell -19% year-over-year because the company’s manufacturing is under scrutiny from the FDA following a 2014 warning letter that called its devices adulterated.
“FDA remediation and continuation of quality systems overhaul remains at the top of the list of our strategic priorities. The achievement of remediation and quality systems plan commitments as submitted to the FDA and assuring that our global quality certifications are maintained remain as essential goals,” Mason said during an earnings call.
According to Staar’s quarterly earnings release, the company chose to delay shipment of some intraocular lenses due to the quality control issue, and is “reviewing the commercial fitness” of some of its cataract lens offerings.
