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FDA Advisory Panel Supports Staar Surgical Visian Toric Lens

FDA’s Ophthalmic Devices Panel voted in favor of Staar Surgical’s Visian toric implantable collamer lens to correct myopic astigmatism in adults ages 21 to 45. Earlier safety and missing data questions on the lenses were reviewed, but ultimately, the panel said the product’s proposed indication outweighed risk for use in specified patients.

Six of ten FDA Ophthalmic Devices Advisory Panel members see a clear future for Staar Surgical Co.’s Visian toric implantable collamer lens, voting favorably at a March 14 panel meeting that the lens’ benefits outweigh its risks in patients age 21 to 45 with myopic astigmatism. If FDA grants Staar Surgical’s PMA application for the Visian, the lens will be marketed as the only approved phakic, or nearsightedness, intraocular lens in the U.S. for correction of astigmatism.

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