Visian ICL granted FDA approval

MONROVIA, Calif. — An implantable, foldable collamer lens for the correction of myopia has been granted regulatory approval in the United States, according to the device’s marketer.

STAAR Surgical’s Visian ICL “allows an incision up to 50% smaller than competing technology, and its placement in the eye behind the iris provides a more aesthetically pleasing outcome,” the company said in a press release. The lens received Food and Drug Administration approval for the correction of myopia in adults, STAAR added.

STAAR said it will begin shipping the phakic IOL to “trained doctors” in 6 to 8 weeks. The lens is already approved for sale in 41 countries, including those in the European Union. STAAR said the lens has been implanted in more than 40,000 eyes worldwide.

“We believe the ICL offers patients and their doctors opportunities to achieve higher quality visual outcomes compared with competing technology, and this characteristic will be an important growth driver of the refractive phakic implant market,” said David Bailey, president and chief executive officer of STAAR.

The Visian ICL is a refractive phakic implant intended for placement in the posterior chamber of the eye. The approved models are indicated for the correction of myopia in adults with myopia ranging from –3 D to no more than –15 D with astigmatism no more than 2.5 D at the spectacle plane, and the reduction of myopia in adults with myopia ranging from –15 D to –20 D with astigmatism no more than 2.5 D at the spectacle plane, in patients 21 to 45 years of age with anterior chamber depth of 3 mm or greater, and a stable refractive history within 0.5 D for 1 year prior to implantation, STAAR said.

Mr. Bailey said more than 860 surgeons have completed the first phase of training, which focuses on correct technique.

STAAR said training courses and educational symposia will be a focus for the company at upcoming industry conferences, such as the Royal Hawaiian Eye Meeting next month in Maui.