Staar Surgical seeks premarket approval for Visian Toric implantable lens

By Elaine Rigoli

Tampa, Fla., April 28 - Staar Surgical Co. has submitted a premarket approval (PMA) supplement to the Food and Drug Administration for its Visian TICL, a toric implantable Collamer lens, designed to treat both nearsightedness and astigmatism.

The Visian TICL supplemental filing supports an indication for use in adults 21 to 45 years of age for the correction of myopia ranging from -3.0 to -20 diopters with astigmatism of 1 to 4 diopters, according to a news release.

"The submitted data indicates very positive surgical outcomes, in fact, 98% of all patients reported that they were 'very' or 'extremely' happy with the surgical results and no patients were dissatisfied. The Visian line remains our most significant opportunity for profitable growth in the future and our submission of the TICL PMA supplement is another important milestone toward executing our long-term strategy," president and chief executive officer David Bailey said in the release.

"If approved, the TICL will be the only phakic implantable lens product available in the U.S. to treat myopia and astigmatism. Based on the interest we have seen in international markets where the TICL is already approved, we believe our product can uniquely serve the growing needs of the dynamic refractive market in the U.S," he added.

The review period for a PMA supplement is typically 180 days from the date of submission to the FDA.

Monrovia, Calif.-based Staar Surgical develops minimally invasive ophthalmic products employing proprietary technologies.

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