Last updated on April 16, 2014 at 1:21 EDT

STAAR Surgical Receives Approval to Market Its Toric Collamer® IOL in Europe

November 16, 2011

MONROVIA, Calif., Nov. 16, 2011 /PRNewswire/ — STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced it has received CE Mark approval for its nanoFLEX(TM) Toric Collamer® Single Piece IOL. The CE Mark approval of the nanoFLEX Toric IOL will allow the Company to expand its product offerings in the European Union (EU) to include an improved solution for cataract patients with astigmatism. The nanoFLEX Toric IOL was approved for correction of 1.0 diopters to 4.0 diopters of cylinder in 0.5 diopter steps. The Company received CE Mark approval for its nanoFLEX IOL in April 2011 and began shipments in the third quarter of 2011.

“Approval of the nanoFLEX Toric IOL in Europe marks another important milestone for STAAR,” said Barry G. Caldwell, President and CEO. “Approval in Europe is the first step in a process to establish the nanoFLEX Toric IOL globally as an improved option for cataract patients who also have astigmatism. We have also been in discussions with the FDA about the requirements to obtain approval of the nanoFLEX Toric IOL in the U.S. The nanoFLEX Toric IOL is based on our proprietary Collamer material, which offers significant benefits to patients and surgeons. It provides a superior quality of vision for the patient and the flexibility of the Collamer material allows it to be implanted through a 2.2 mm incision. This product is also a key part of our overall margin enhancement strategy for our IOL products.”

According to the Market Scope 2011 Global IOL Market Report, the global market for Toric IOLs in 2011 is $180 million and will grow to $300 million in the next five years. During that same period, units are estimated to reach 1 million annual units globally. While 35% of all cataract patients have a clinically significant degree of astigmatism, only 2.5% of cataract patients are receiving a Toric IOL today. Approval of the cylinder range from 1.0 to 4.0 diopters allows the lens to correct over 95% of the eyes with clinically significant astigmatism. The global average selling price for Toric IOLs is estimated to be $365. The market in Europe is approximately $30 million in 2011 and is expected to more than double in the next five years. It is estimated today that only 3% of cataract patients receive a Toric IOL in Europe as compared to an 8% rate in the U.S.

“The recent launch of our nanoFLEX IOL in select countries in Europe is going well,” said Hans Blickensdoerfer, STAAR’s President of Europe, Middle East and Latin America. “It is a well differentiated product and, while it is early in the process, our distributors have made progress in penetrating our target markets. The nanoFLEX Toric IOL is an important addition and will significantly expand our opportunities in the premium IOL segment of our target markets, as well as allowing us to enter new markets in Europe. The average selling price in Europe is nearly $300 and this provides a comfortable margin for both STAAR and our distributors. With the nanoFLEX Toric, we have established the new nanoFLEX Family of Premium IOLs.”

Collamer is a highly compressible, unique lens material composed of collagen, a UV-absorbing chromophore, and a poly-HEMA based copolymer. The compressibility of the material allows the lens to be delivered through a small incision in a controlled and predictable manner. The Collamer material provides excellent quality of vision due in part to its anti-reflective surface, which reduces or eliminates the occurrence of glare and halos. In addition, the Collamer material has demonstrated that it induces fewer higher order aberrations than other lens materials. It has a water content of 40% which is over 50% higher than any other FDA approved hydrophilic IOL material. This same material is used to manufacture the Company’s worldwide leading refractive lens, the Visian® ICL(TM).

The nanoFLEX IOL was the lens used by STAAR’s Collamer Accommodating Study Team (CAST), which first reported results in late 2009 that were very promising regarding intermediate and near vision results. The Company’s Research and Development team has been working on some minor design changes to the nanoFLEX IOL that potentially could improve the near vision results. The Company believes that these product enhancements would require only a notice of change for regulatory approvals. The Company also continues to work with the FDA on a clinical study protocol that could potentially provide clinical data for additional product claims.

Additional information on the nanoFLEX Collamer Aspheric Single Piece IOL can be viewed on the Company’s website: www.nanoflexlens.com. You can also visit: www.facebook.com/nanoflexlens.

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. 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.” Over 250,000 Visian ICLs have been implanted to date; to learn more about the ICL go to: www.visianinfo.com, www.facebook.com/visianicl or www.twitter.com/visianicl. 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 sales, expected prices, the effect of new product approvals on our business, the development of future products and future product approvals, 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: our need to compete against much larger and better financed companies in selling IOLs; the lack of an established market for Collamer IOLs outside the U.S., the risk that products in research and development may face unexpected technical hurdles, costs or delays; and the broad discretion of regulatory agencies to deny or delay product approvals. 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 these subjects 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 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.

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SOURCE STAAR Surgical Company

Source: PR Newswire