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SYS-CON MEDIA Authors: Liz McMillan, Kevin Jackson, Peter Silva, Greg Wind, Glenn Rossman

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Ventura County Eye Surgeon Helps Persuade FDA Panel to Support Approval of Long-Awaited Lens Implant

First-of-Its-Kind in the U.S. Toric Implant for Treating Nearsightedness and Astigmatism Already Cleared for Use in 60-Plus Countries; Data Reported by Dr. Paul Dougherty Helps Prompt FDA Advisory Panel Recommendation

WEST LAKE VILLAGE, CA and CAMARILLO, CA -- (Marketwired) -- 03/25/14 -- Ophthalmic surgeon and researcher Dr. Paul Dougherty presented evidence and opinion at the U.S. Food and Drug Administration (FDA) Medical Devices Advisory Committee hearing May 14th that helped persuade the committee to vote in favor of STAAR Surgical's Visian® Toric Implantable Collamer® Lens (TICL™) -- the first-of-its-kind in the U.S. lens implant designed to treat both nearsightedness and astigmatism in a single procedure.

Dr. Dougherty explained to the Committee how the Implantable Collamer Lens (ICL) is safe and effective for patients who meet the treatment criteria. He also discussed how the Toric version of the ICL is an excellent treatment option for those with nearsightedness and astigmatism. Without the Toric ICL, such patients must undergo two separate procedures (typically the ICL and LASIK or PRK) to correct their vision, which can double the risk of surgery.

Upon review of testimony from Dr. Dougherty and other leading ICL surgeons, the FDA's Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices, and STAAR Surgical, the Advisory Panel recommended to the Commissioner of Food and Drugs that the Toric ICL be made available to surgeons and patients in the U.S.

"The recommendation for the Toric ICL is good news for the many nearsighted people in the U.S. who can benefit from this long-awaited technology," said Dr. Dougherty. "In my experience, the ICL provides better quality vision and fewer night vision problems compared to other available treatment options."

Dr. Dougherty went on to explain how the ICL does not require the surgeon to remove corneal tissue (as is the case with LASIK), and therefore preserves the eye's corneal structure. While it is intended to provide permanent vision correction, the lens can also be removed if necessary. Finally, he pointed to ancillary benefits such as the ICL's built-in UV protection, which may help patients delay the onset of cataracts.

"Superior vision, fewer adverse side effects, reversibility and even UV protection are among the ICL's benefits, and they're the reason why surgeons across the U.S. look forward to making the Toric ICL available to their patients with nearsightedness and astigmatism," he added.

The Toric ICL is already approved for use in more than 60 countries. Its long-awaited approval by the FDA has prompted a significant number of U.S. patients with astigmatism to travel to Mexico, Canada or other nations where the lens is already available to consumers.

Dr. Dougherty's presentation during the open public hearing included data from his nearly 15 years of experience implanting the ICL on both an investigational and routine basis. He was an original clinical trial investigator for the lens, and has performed more than 1,000 ICL procedures.

The Visian Toric ICL (TICL) 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, which was approved in the U.S. in 2005. The difference between the two is the toric optical feature of the TICL designed to permit the surgeon to correct both myopia (nearsightedness) and astigmatism (blurriness due to an irregularly shaped cornea) in a single procedure.

About Dougherty Laser Vision and Dr. Paul Dougherty

For nearly 20 years, Dougherty Laser Vision has brought the benefits of LASIK, lens implants, cataract surgery and other advanced vision correction procedures to patients who demand the highest quality care. Medical Director Dr. Paul Dougherty is an internationally renowned eye surgeon who has helped pioneer many of today's most advanced techniques. He also serves as assistant clinical instructor of ophthalmology at UCLA's Jules Stein Eye Institute and as a principal investigator for numerous FDA trials. Dr. Dougherty was one of the first surgeons in the US to perform laser vision correction on an investigational basis, and had the procedure on his own eyes in 1997. His book -- "See for Yourself - A Patient's Guide to Permanent Vision Correction," is a popular guide for consumers. Dougherty Laser Vision has locations throughout Los Angeles and Ventura Counties. More information is available at www.DoughertyLaserVision.com.

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