STAAR Surgical has reported that its Visian Toric Implantable Lens or TICL received favorable votes to three questions presented to the US Food and Drug Administration's (FDA) Ophthalmic Devices Panel of the Medical Devices Advisory Committee.
The Ophthalmic Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in the eye and makes recommendations to the Commissioner of Food and Drugs.
The panel voted favorably on all three questions posed to it by the FDA’s Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices:
– Is there reasonable assurance that the Visian Toric Implantable Collamer Lens is safe for use in patients who meet the criteria specified in the proposed indication?
– Is there reasonable assurance that the Visian Toric Implantable Collamer Lens is effective for use in patients who meet the criteria specified in the proposed indication?
– Do the benefits of the Visian Toric Implantable Collamer 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?
STAAR Surgical president and CEO Barry Caldwell noted the FDA, the panel members, and the company team spent a great deal of time preparing for the Visian TICL panel session.
"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 Visian TICL’s safety and efficacy for patients with myopia and astigmatism.
"Additionally, we are grateful to the physicians who have worked extensively with our team throughout this process to provide valuable presentations to the Panel on the Visian TICL. We also appreciate the valuable testimony provided by physicians during the open public hearing who gave time from their practices to participate in the meeting.
"The STAAR team looks forward to working with the FDA to complete the process to make the Visian TICL available to surgeons and patients in the US," Caldwell added.
The Visian Toric ICL is a refractive phakic implant placed in the posterior chamber of the eye between the iris and the natural crystalline lens. It shares the same unique, foldable design as STAAR Surgical’s Visian ICL.
The difference between the two is the toric optical feature of the Visian Toric ICL is designed to permit the surgeon to correct both myopia and astigmatism in a single procedure. There is no currently approved phakic IOL in the US for the correction of astigmatism.
The FDA approved STAAR Surgical’s Visian ICL in December 2005 to treat myopia in adults and the company began commercial sales in the US in 2006. The lens has gained acceptance in the US market since its introduction STAAR’s Toric ICL clinical trial 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 show that 82% of the eyes were 20/20 or better uncorrected and 54% of the eyes were 20/16 or better.