Favorable FDA Panel Vote for SAAR Surgical’s Visian ® staaTICL

Implantable lens manufacturer STAAR Surgical Company tells us that its Visian Toric Implantable Lens or TICL received favorable votes to three questions presented to the U.S. FDA’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee.

Background

Sharing the same unique, foldable design as STAAR Surgical’s Visian ICL, 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. Unlike its brother however, 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 U.S. for the correction of astigmatism. In the over 60 markets in which the Visian ICL and TICL are in commercial use approximately 40% of the units and approximately 50% of the revenue are the TICL version.

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?

Company comments

“The FDA, the Panel members, and the STAAR team spent a great deal of time preparing for the Visian TICL panel session,” said Barry Caldwell, President & CEO. “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 U.S.”

Source: STAAR Surgical, Inc., PR Newswire

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