FDA Advisory Panel Votes in Favor of STAAR Surgical's Visian® Toric Implantable Collamer® Lens, TICL™
The Panel voted favorably on all three questions posed to it by the
- 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?
"The
Surgeons presenting during the Company's session to provide support for the TICL approval included: Dr.
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
The
The proposed indications for use of the Visian TICL, as presented during the panel meeting, was as follows:
- for the correction of myopic astigmatism in adults 21-45 years with spherical equivalent ranging from -3.0D to ≤ -15.0D with cylinder of 1.0D to 4.0D;
- for the reduction of myopic astigmatism in adults 21-45 years with spherical equivalent ranging from greater than -15.0D to -20.0D with cylinder 1.0D to 4.0D;
- fith an anterior chamber depth (ACD) of 3.0 mm or greater, when measured from the corneal endothelium to the anterior surface of the crystalline lens and a stable refractive history (within 0.5 Diopter for 1 year prior to implantation); and
- the Visian TICL is intended for placement in the posterior chamber (ciliary sulcus) of the phakic eye.
About
STAAR, which has been dedicated solely to ophthalmic surgery for over 25 years, designs, develops, manufactures and markets implantable lenses for the eye and delivery systems therefor. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR's lens used in refractive surgery as an alternative to LASIK is called an Implantable Collamer® Lens or "ICL." A lens used to replace the natural lens after cataract surgery is called an intraocular lens or "IOL." More than 400,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: www.visianinfo.com. STAAR has approximately 335 full time employees and markets lenses in over 60 countries. Headquartered in
Safe Harbor
All statements in this press release that are not statements of historical fact are forward-looking statements, including statements about any of the following: any projections of financial items; the potential future performance of the company or its products, such potential sales of the Visian TICL in the U.S. or prospects for achieving such potential future performance; and statements regarding expectations for future success. Important additional factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the company's Annual Report on Form 10-K for the year ended
These statements are based on expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those described in the forward-looking statements.
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