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news.Staar Surgical has received approval from the State Food and Drug Administration of the People's Republic of China or SFDA to market the Staar Visian Toric Implantable Collamer Lens or TICL to ophthalmologists and other eye care professionals in the country for the treatment of nearsightedness and astigmatism.
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In addition the SFDA granted approval to Staar to market the Staar Visian ICH, an implantable collamer lens to correct hyperopia or farsightedness. These approvals in China are for treatments of myopic patients with refractive errors between -3.00 and -20.0 and astigmatism up to six diopters. The hyperopic approval is for patients with refractive errors between +1.0 to +4.0. Made of Staar’s proprietary, highly biocompatible Collamer material, the ICL, TICL and the ICH are said to be the the only minimally invasive foldable lenses of their kind approved for the Chinese commercial market.
Barry Caldwell, president and CEO of Staar Surgical, said: “The approval of both the Visian Toric ICL and the Visian Hyperopic ICL represents a solid endorsement of the Staar technology. With these additional approvals, we are positioned to expand our presence in a market where the demographics are very favorable.”