STAAR Surgical’s Visian® Toric Implantable® Collamer Lens (TICL™) is three steps closer to getting FDA approval and making it a first of its kind product in the U.S.
The Visian TICL recently received favorable votes to three questions presented to the U.S. Food and Drug Administration’s (FDA) Ophthalmic Devices Panel of the Medical Devices Advisory Committee.
The panel, which reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in the eye before making recommendations to the Commissioner of Food and Drugs, answered favorably to all three questions presented 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?
“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,” said Barry Caldwell, President and CEO, STAAR Surgical Company. “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 U.S.”
The Visian TICL is a refractive phakic implant placed in the posterior chamber of the eye between the iris and the natural crystalline lens. It has the same unique, foldable design as the STAAR Surgical Visian® ICL, but the toric optical feature of the TICL allows surgeons to treat astigmatism as well as myopia in one procedure.
In the U.S., clinical trials for the TICL 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. 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.
Though there are no phakic IOLs currently approved in the U.S. for the correction of astigmatism, the STAAR’s Visian TICL has been available internationally for over then years with 10,000 successful implantations worldwide.