STAAR Surgical Companyl’s New Visian ICL(TM) Technology Described as “Incredible Step Forward” at ESCRS Congress

MONROVIA, Calif., Sept. 22, 2011 /PRNewswire/ -- STAAR Surgical Company (Nasdaq: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced the Visian Implantable Collamer® Lens (ICL), and new Visian ICL with CentraFLOW technology utilizing the KS-AquaPORT, were featured prominently in twice as many presentations at the 2011 Congress of European Society of Cataract and Refractive Surgeons (ESCRS) as those on the ICL during last year’s Congress. This year’s event took place from September 17 to 21, 2011, in Vienna, Austria.

Attention was focused on the new Visian ICL with CentraFLOW technology that utilizes the KS-AquaPORT, eliminating the need for an iridotomy before the procedure. This allows the procedure to be as convenient for the surgeon and patient as LASIK. It also allows the ICL procedure to be more economical for the surgeon. The Visian ICL, which is currently the fastest growing refractive technology, is expected to enjoy an even greater growth rate with this enhancement.

The presentations, based on studies conducted by leading surgeons around the world, confirmed that the Visian ICL and new Visian ICL with CentraFLOW technology offer superior visual results over a wide range of myopic and hyperopic refractive errors, including those within the most popular LASIK areas of treatment. These presentations also confirmed the safety and efficacy of the Visian ICL and Visian ICL with CentraFLOW technology.

“This was a game changing meeting for STAAR and the ICL technology,” said Barry G. Caldwell, President and CEO of STAAR. “Our two latest evolutions of the ICL technology allow a surgeon to treat all LASIK eligible patients and more, and the procedure is now as convenient for both the surgeon and patient as the LASIK procedure. This is true for the first time in our history and it allows us to compete head to head with LASIK. At last year’s meeting we announced worldwide that a Visian ICL was implanted every ten minutes, the comparison is now a Visian ICL is implanted every seven minutes.”

Highlights among presentations on Visian ICL included:

• Dr. Roberto Zaldivar from Argentina originally worked with STAAR on putting a port on the ICL over 17 years ago. Based on his observations, he called the CentraFLOW technology an “incredible step forward” as it saves time for the surgeon and the patient and eliminates the potential for a pupillary block.
• Dr. Kimiya Shimizu from Japan, for whom the KS-AquaPORT is named, presented data related to 42 patients implanted with the current ICL in one eye and the new Visian ICL with CentraFLOW Technology in the other. He found that after a three-year follow up 82 percent of the patients preferred the vision from their eye with the new ICL. During the ESCRS free paper session Dr. Shimizu presented data concluding that post-operative contrast sensitivity was significantly improved with the Toric ICL when compared to LASIK.
• Dr. Erik Mertens from Belgium reported findings from implanting 28 of the new Visian ICLs with CentraFLOW Technology. He reported no intraocular pressure or glare issues from the patients, and that these patients were 100 percent satisfied.
• Dr. Jaime Aramberri from Spain reported positive results from 24 implants of the new Visian ICL with CentraFLOW Technology performed by three Spanish ophthalmologists. He also pointed out potential long term-benefits from the new technology that can be studied over time.
• Dr. Xiaoying Wang from China during the ESCRS free paper session compared the ICL in one eye with LASIK in the opposite eye and concluded that the contrast sensitivity was better with the ICL eyes and overall superior to the LASIK eyes.
• Dr. Bruce Allen from the UK in the ICL Experts Symposium pointed out the advantages of maintaining a “virgin cornea.” LASIK patients, because of changes made to their corneas during their initial procedures, may not be candidates for future technology for vision correction, like multi-focal IOLs.

The 8th Annual Visian ICL Expert Meeting, sponsored by STAAR, was held prior to the conference with more than 100 surgeons from 34 countries in attendance “by invitation only.” Among the presenters was Dr. Gregory Parkhurst from the US, the former Chief of Ophthalmology and Refractive Surgery at Fort Hood, Texas. He presented on evaluating night time visual results with the Visian ICL. He concluded there was a better quality of vision and better contrast sensitivity obtained with the Visian ICL when compared to LASIK. He said 1,500 ICL procedures have been performed at Fort Hood, the world’s largest military installation.

STAAR also sponsored a lunch symposium on refractive surgery that was attended by more than 350 surgeons. Dr. Amar Agarwal from India moderated the session of five presentations regarding Revolutions in Refractive Surgery. The presenters were: Dr. Georges Baikoff from France, Dr. Erik Mertens from Belgium, Dr. Roberto Zaldivar from Argentina, Dr. Alaa El-Danasoury from Saudi Arabia, and Dr. Jose Alfonso from Spain. Some of the highlights of the symposium include:

• Dr. Baikoff, one of the pioneers of anterior segment Phakic IOLs commented that today he would implant a Visian ICL over any alternatives. Over the past 20 years he has tried all of the anterior segment Phakic IOLs and now prefers one positioned in the posterior chamber like the ICL.
• Dr. Mertens had a patient on the podium who had recently received the new Visian Toric ICL with CentraFLOW technology. This patient had only -0.75 diopter of myopia and 1.25 diopters of astigmatism. He was the beneficiary of both recently approved V4b and V4c technologies. He was extremely happy with the results and confirmed that he could see better now than he ever could with glasses or contact lenses.

In addition during the Experts Symposium a Gala Dinner was held to celebrate over a quarter of a million Visian ICLs implanted. Dr. Jong-Ho Lee from South Korea was given a very special award for implanting over 10,000 Visian ICLs since 2003. Dr. Kimiya Shimizu of Japan was awarded the Innovators Award 2011 for his work on the new CentraFLOW technology utilizing the KS-AquaPORT.

“This was our most successful ESCRS ever and the presentations clearly demonstrated the benefits of our new Visian ICL technologies, particularly when compared with the alternative LASIK surgery,” Mr. Caldwell continued. “The roll-out of our new technologies is proceeding well. We have established a solid financial foundation with double digit revenue growth and with the new product introductions now plus a robust new product pipeline, we are extremely optimistic about the outlook for STAAR.”

About STAAR Surgical

STAAR, which has been dedicated solely to ophthalmic surgery for over 25 years, designs, develops, manufactures and markets implantable lenses for the eye. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. A lens used to replace the natural lens after cataract surgery is called an intraocular lens or “IOL.” A lens used in refractive surgery as an alternative to LASIK is called an Implantable Collamer® Lens or “ICL.” Over 250,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: www.visianinfo.com. STAAR has approximately 300 full-time employees and markets lenses in approximately 50 countries. Headquartered in Monrovia, CA, it manufactures in the following locations: Nidau, Switzerland; Ichikawa City, Japan; Aliso Viejo, CA; and Monrovia, CA. For more information, please visit the Company’s website at www.staar.com or call 626-303-7902.

Collamer® is the registered trademark for STAAR’s proprietary biocompatible collagen copolymer lens material.

Safe Harbor

All statements in this press release that are not statements of historical fact are forward-looking statements, including any statements about the effect of new product approvals on our business, statements about planned product launches, any statements of belief and any statements of assumptions underlying any of the foregoing.

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. The risks and uncertainties include the following: the effect of poor global economic conditions on sales, especially sales of products like the ICL used in non-reimbursed elective procedures; our limited resources to promote new products; the risk that product launches may be affected by unplanned delays or be less successful than we expect; the willingness of surgeons and patients to adopt a new product and procedure; the entrenched market position of laser-based procedures for many conditions treated by the Visian ICL; and patterns of Visian ICL use that have typically limited our penetration of the refractive surgery market. STAAR assumes no obligation to update its forward-looking statements to reflect future events or actual outcomes and does not intend to do so.

SOURCE STAAR Surgical Company