STAAR Surgical’s nanoFLEX(TM) CollamerÂ® IOL Receives CE Mark Approval
MONROVIA, Calif., April 28, 2011 /PRNewswire/ — STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of minimally invasive ophthalmic products, today announced CE Mark approval for its nanoFLEX(TM) CollamerÃ‚® Single Piece IOL which can be injected through a 2.2 mm incision with the nanoPOINT(TM) Injector System. The nanoFLEX IOL incorporates the Company’s proprietary aspheric optic design (patent pending), which is optimized for the naturally curved anatomy of the eye. CE Mark approval allows the Company to market nanoFLEX in the European Economic Area (EEA) and can serve as a foundation for some additional approvals in countries outside the EEA.
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 VisianÃ‚® ICL(TM).
“The nanoFLEX approval to market in Europe is a very important milestone for STAAR Surgical,” said STAAR Surgical CEO Barry G. Caldwell. “The CE Mark approval positions us to build our global IOL strategy to drive premium product sales growth in key and profitable markets throughout the world. The global platform of our current IOL products includes the current silicone and acrylic preloaded IOLs. We will now add the excellent benefits of the Collamer material through the nanoFLEX IOL, which can be implanted through a 2.2 mm incision. The increased demand can be met with our existing production capacity, and the higher volume should lower our unit production cost. Our R&D IOL product pipeline includes transitioning our silicone toric IOL to the Collamer platform with the nanoFLEX Toric IOL. In addition, design changes to the current nanoFLEX IOL intended to further enhance near and intermediate visual results are underway in a project called nanoFLEX II. We also plan packaging both nanoFLEX II and nanoFLEX Toric into a new preloaded injection system. Globalizing our IOL offerings fits our corporate strategy of gross margin expansion with the introduction of premium products.”
“The nanoFLEX IOL launch will focus on key European markets and will put our distribution channel into a unique position to effectively compete in a well-established market segment,” added Hans Blickensdoerfer, STAAR’s President of Europe and Latin America. “The positioning of the nanoFLEX IOL as a premium cataract solution is exciting and will allow patients to benefit from the exceptional properties of the Collamer material. It will also allow surgeons to charge the patient for these benefits in primarily the German, French and U.K. markets. In addition, our wide base of ICL surgeons will finally be able to offer a cataract IOL technology that features the same superior quality of vision benefits as the ICL. Our key distributors have already been trained on the product and should be able to begin marketing during the second quarter.”
The nanoFLEX IOL was the lens used by STAAR’s Collamer Accommodating Study Team (CAST) that 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 intermediate and 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.
With a blended vision strategy using the nanoFLEX lens, surgeons can provide patients with good quality near, intermediate and distance vision. This pan-focal vision has reportedly left patients highly satisfied with their vision at all distances. In 2010, Dr. Kenneth Lipstock from the Lipstock Cataract Center in Richmond, Virginia, presented retrospective results from patients previously treated with nanoFLEX using a Blended Vision strategy. In this study he found that the average near visual acuity could be improved to 20/25 with an average myopic offset of just 1.3 diopters, which was well tolerated by 100% of the patients treated.
At the 2011 American Society of Cataract and Refractive Surgeons (ASCRS) meeting, Dr. Lipstock presented a paper on the near and intermediate reading acuity and reading speed. The study showed that when patients received nanoFLEX with Blended Vision their near reading acuity was equivalent and their intermediate reading acuity was superior as compared to the published data for all premium accommodating and multifocal IOLs approved for use in the U.S. At the nanoFLEX Blended Vision Mini Symposium during the ASCRS meeting Dr. Lipstock noted, “The nanoFLEX gives pan-focal visual outcomes comparable to premium IOLs, a great option for patients who cannot afford premium IOL presbyopic correction.”
A growing number of surgeons who offer patients enhanced outcomes such as blended vision or monovsion provide additional services and diagnostic tests to ensure the patients are free of astigmatic errors that cannot be treated with monofocal IOLs. The need for these tests and services is presented to the patient in advance along with the fact they will be responsible for the cost of such services.
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 CollamerÃ‚® Lens or “ICL.” Over 200,000 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.
CollamerÃ‚® is the registered trademark for STAAR’s proprietary biocompatible collagen copolymer lens material.
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, 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 willingness of surgeons and patients to adopt a new product and procedure; 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 CollamerÃ‚® lens material, and the reported results of blended vision studies with nanoFLEX, 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 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.
CONTACT: Investors Media EVC Group EVC Group Jenifer Kirtland/Doug Sherk Christopher Gale, 415-896-6820 646-201-5431
SOURCE STAAR Surgical Company