FDA panel votes in favor of STAAR Surgical’s toric ICL

Monrovia, CA-STAAR Surgical’s Visian toric implantable lens (TICL) has received favorable votes to three questions presented to the FDA’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee.

The panel voted favorably on all three questions posed to it by the FDA’s Division of Ophthalmic, Neurological, and Ear, and Nose and Throat Devices:

1.     Is there reasonable assurance that the lens is safe for use in patients who meet the criteria specified in the proposed indication?

2.     Is there reasonable assurance that the lens is effective for use in patients who meet the criteria specified in the proposed indication?

            3.     Do the benefits of the lens for use in patients who meet the criteria specified in the proposed indication outweigh the risks for use in patients who meet the criteria specified in the proposed indication?

“The FDA, the panel members, and the STAAR team spent a great deal of time preparing for the . . . session,” said Barry Caldwell, president and chief executive officer of STAAR Surgical. “We went into the panel session understanding and acknowledging that the data under review from the trial study was more than 10 years old and subject to rigorous review.

“We appreciate both the FDA’s and the panel’s work to understand the data and clinical evidence we were able to provide regarding the (lens’) safety and efficacy for patients with myopia and astigmatism,” Caldwell continued.

The clinical trial that studied the lens included 210 eyes in 124 patients with a mean myopia of -9.37D and a mean astigmatism of +1.95D, and an average age of 35.

The 12-month clinical outcomes showed that 82% of the eyes were 20/20 or better uncorrected, and 54% of the eyes were 20/16 or better.

The FDA also approved another lens, STAAR Surgical’s Visian ICL, in December 2005 to treat myopia in adults. STAAR Surgical began commercial sale in the United States in 2006.

The lens has gained acceptance in the United States market since its introduction.

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