Healthcare Industry News:  cataract 

Devices Ophthalmology

 News Release - September 8, 2010

STAAR Surgical Launches New Visian ICL Product Line Extensions at ESCRS

New Visian ICL Allows for Treatment of Virtually All Myopes and Hyperopes

New Visian Hyperopic Toric ICL Now Available in International Markets

Over 40 Presentations on Visian ICL Successes during Meetings around ESCRS

MONROVIA, Calif., Sept. 8 -- (Healthcare Sales & Marketing Network) -- STAAR Surgical Company (Nasdaq:STAA ), the leading worldwide developer, manufacturer and marketer of phakic intraocular lenses, today announced that the Visian Implantable Collamer® Lens (ICL) was featured prominently in more than 40 presentations by leading ophthalmologists at meetings prior to and during the 2010 Congress of European Society of cataract and Refractive Surgeons (ESCRS) held in Paris, France from September 4 through 8, 2010. The presentations, based on studies conducted by surgeons throughout the world, confirmed that the Visian ICL offers 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 over a period of 17 years.

The 7th Annual Visian ICL Expert Meeting, sponsored by STAAR, was held prior to the conference with 100 surgeons from 34 countries in attendance. There were 26 presentations and eight specialized breakout sessions on ICL topics over a two-day period. During the opening presentation Hans Blickensdoerfer, President of STAAR Europe, Latin America and the Middle East, demonstrated the growth in Visian ICL procedures by comparing the rate of ICL implants per minute. In 2008, worldwide, a Visian ICL was implanted every 20 minutes; that rate has doubled in 2010 to one implant every 10 minutes.

"This was our seventh annual meeting of this type and I believe it was the best," commented Mr. Blickensdoerfer. "We continue to see strong growth in the Visian ICL throughout the world and believe that the newly expanded Visian ICL diopter ranges launched here at ESCRS more than doubles the market opportunity for Visian and allow us to compete directly within the most popular myopic and hyperopic ranges of treatment with LASIK. Key presentations during the meeting demonstrated that though the Visian ICL has very good results in the higher refractive areas, it can have even better visual results in the lower ranges of refractive procedures where LASIK is most popular currently."

During the formal free paper presentation sessions at the ESCRS meeting there were 17 papers on the Visian ICL, 14 scientific posters and two courses. All of these continued to reinforce the Visian ICL technology as a safe and effective option for addressing a wide range of myopia, hyperopia and astigmatism.

Some of the highlights during presentations at the Visian ICL Expert's Meeting and the ESCRS included:

* Dr. Paul Dougherty from the U.S. presented results showing that the Visian ICL was a very safe and effective treatment for lower myopes. His preference for patients with myopia over 3.0 diopters of refractive error is the Visian ICL. In his practice the Visian ICL visual results (88% of eyes 20/20 or better), accuracy and safety are better than LASIK. Ophthalmologists in International markets that accept CE Mark Approval will now be able to treat below 3.0 diopters.

* Several presentations reinforced the low complication rate of cataract formation in patients with the Visian ICL.

Dr. Tobias Neuhann presented the results of the German Study Group, which reflected a 1.4% rate of cataract formation among the 436 patients in the study.

In a study of visual outcomes and the safety of the Visian ICL in Chinese eyes, Dr. Xingtao Zhou reported a cataract formation rate of 1.67% in his study of 658 eyes.

Dr. Jose F. Alfonso from Spain reported a cataract formation rate of 1.4% in a seven-year study of 734 patients.

These studies compare with an incidence of 1.3% anterior subcapsular cataract formation in STAAR's FDA clinical study with five years follow-up. All eyes with cataract formation were associated with very high myopes, over -12.5 diopters. Only one of those eyes was from a patient younger than 40 years of age. The total study included 526 eyes.

* Dr. Scott Barnes from Fort Bragg in the U.S. reported that 75% of the soldiers in which he has implanted the Visian ICL see better now than they did with contact lenses before surgery, and none saw worse. In contrast only 10% of soldiers who underwent LASIK reported better results than with contact lenses and 50% responded their vision was worse. The average age reported on was 28 years and over one third of the respondents had a refractive error of -6.0 diopters or less.

* Dr. Cheryl Lee from Singapore opened an Implantable Lens Centre in January of 2009. Her experience has been that the quality of vision with the Visian ICL is better than vision with glasses, contact lenses or LASIK. Her center now has patients walk in to ask for the ICL.

In addition, Dr. Kenneth Lipstock, an ophthalmologist based in Richmond, Virginia and a member of STAAR's CAST (Collamer Accommodating Study Team), presented on the nanoFLEX™ IOL, which uses the same Collamer material of the ICL. The nanoFLEX, an intraocular lens used for the treatment of cataracts, has demonstrated in early clinical observations the ability to improve near and intermediate vision. Dr. Lipstock was impressed by the results at near and intermediate vision with the nanoFLEX IOL, reporting that nanoFLEX intermediate visual results were equal to or better than competitive products including Crystalens® HD and 5, ReZOOM® and ReSTOR®. Dr Lipstock also presented retrospective data on patients where he had used nanoFLEX for monovision treatments. His data showed that with less than a 2 diopter offset, on average his patients could achieve 20/20 distance vision and 20/25 near vision. In Dr. Lipstock's view, the nanoFLEX IOL is a great option for patients who do not want to spend extra money for presbyopic correction.

On Monday evening, STAAR Surgical sponsored a Symposium on refractive surgery that was attended by over 400 surgeons. In 16 video based presentations, leading global refractive surgeons demonstrated how practitioners can further fine tune success in refractive surgery results.

"The newly expanded indications of the Visian ICL for international markets more than doubles the potential market for the ICL," said Barry G. Caldwell, President and CEO of STAAR. "The lower diopter range for both myopic and hyperopic patients will now be available in 0.25 diopter increments with new pricing segmentation, which will allow the Visian ICL to compete more effectively with LASIK. The addition of a Visian Toric Hyperopic ICL and the ability to treat mixed astigmatism will also increase the addressable market with the Visian ICL. Results from an interactive response system of the attendees at the ICL Expert's Meeting revealed the belief shared by 40% of the group that within five years, 40% of all refractive procedures would be with phakic IOLs."

Crystalens® is a registered trademark of Bausch & Lomb Incorporated, AcrySof®ReSTOR® is a registered trademark of Alcon, Inc., and ReZoom™ is a registered trademark of Abbott Medical Optics.

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 180,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: 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: 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 potential market for STAAR's products, growth strategy and expectations for revenue or profitability, 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 negative effect of the global recession on sales of products, especially products such as the ICL used in non-reimbursed elective procedures; the challenge of managing our foreign subsidiaries; 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, patterns of Visian ICL use that have typically limited our penetration of the refractive surgery market, and the potential effect of recent negative publicity about LASIK on the demand for refractive surgery in general in the U.S. STAAR assumes no obligation to update its forward-looking statements to reflect future events or actual outcomes and does not intend to do so.

The preliminary results of research on the accommodating properties of the Collamer® lens material are provided for information of investors. They do not constitute a claim of therapeutic benefit or indications for use. STAAR's current data on the accommodating properties of the Collamer material derive from the reports of individual independent clinicians and have not been subjected to an FDA-approved clinical study. STAAR's current nanoFLEX IOL does not currently have an FDA labeling claim for accommodation. STAAR cannot assure that its further research will support a claim that either its current Collamer lenses or future designs restore the eye's ability to accommodate. If clinical research does not support these claims, or supports only a narrow range of accommodation, STAAR's Collamer accommodation project may not result in increased sales. New lens designs may require clinical research studies and applying for the FDA's premarket approval, which are expensive and could result in delay or denial of approval.

Source: STAAR Surgical

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