Nov 16 2011
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™ 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™.
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.
SOURCE STAAR Surgical Company