MONROVIA, Calif., Nov. 20 /PRNewswire-FirstCall/ -- STAAR Surgical Company today announced the creation of a team of leading ophthalmic surgeons, CAST (Collamer(R) Accommodating Study Team), to work with the Company in a collaborative effort in evaluating the accommodative properties of its Collamer lens technology. Accommodating Intraocular Lenses (IOLs) are implantable lenses designed to restore the eye’s ability to “accommodate,” or to adjust to see near and far as does the natural eye. This ability diminishes with age, and conventional IOLs used in cataract surgery do not restore it.
“Our patented Collamer material is similar to the eye’s natural crystalline lens in its ability to refract light, its flexibility and high water content - all characteristics necessary for high quality visual outcomes,” said Barry G. Caldwell, President and CEO of STAAR Surgical. “During the recent American Academy of Ophthalmic Meeting we formed CAST, which is currently comprised of seven leading ophthalmologists, to investigate the baseline accommodative ability of our Collamer lens. We have reviewed published clinical data by Dr. Liz Davis and Dr. Liviu Saimovici reporting the accommodative properties of our Collamer Single Piece Lens as well as feedback from ophthalmologists involved in other clinical comparisons where the Three Piece Collamer lens showed accommodative properties.”
To explore the accommodative properties of Collamer a phased approach will be used. The members of the CAST team will begin Phase One with the launch of the Collamer Aspheric Single Piece Lens. The initial goal is to collect baseline accommodative data on the performance of the lens. Each member will collect near and distance visual acuity data from their patients implanted with the Collamer lens. STAAR’s research and development team has engineered changes to the current lens to maximize the current levels of accommodation. During Phase Two CAST will evaluate these design changes against the baseline accommodative data collected from Phase One. The Company does not currently believe that these changes would require supplemental premarket approval from the FDA, which means the redesigned lens could be available during 2009. Once data is completed the Company will decide whether to apply for an accommodative labeling claim from the FDA. Phase Three will involve a newly designed Collamer Lens which would require a full clinical study and submission to the FDA for approval to commercialize the device and make accommodative claims in the U.S.
Visian ICL Highlighted on CBS produced show, “The Doctors”
STAAR also uses the Collamer material in the Visian ICL, a product that provides an alternative to LASIK for refractive patients. Dr. Paul Dougherty, who is a member of CAST, appeared on the November 14th airing of a nationally syndicated show, “The Doctors.” On the program Dr. Dougherty was confronted with a patient who had worn glasses since the age of six and had been told by other ophthalmologists that LASIK was not an option. The Visian ICL procedure was performed and the patient was able to see 20/15 or better immediately. The patient reported that she could see “better than ever in her entire life.” Dr. Dougherty referred to the Visian ICL procedure as providing HD Vision or High Quality Vision. The day the segment aired the number of visitors to the Visian ICL website increased by tenfold. The segment can be viewed by visiting: www.visianinfo.com and clicking on media coverage.
Collamer is a proprietary collagen copolymer material developed by STAAR. Its name derives from the material’s composition; it is a 100 percent pure collagen copolymer. Collamer is composed of a poly-HEMA based copolymer, a small amount of collagen and a UV-absorbing chromophore (light absorbing chemical). When fully hydrated, the Collamer lens material possesses a high water content concentrated at the surface of the lens. The distribution of the water content (the bulk at the lens’s surface) creates an anti-reflective interface in Collamer lenses. Other characteristics of the Collamer lens are its low levels of aberrations, biocompatibility and bio-adhesive properties. These unique features make Collamer an ideal optic material and highly suitable for an accommodative lens. STAAR’s formula and processes for making Collamer are protected by patents. Lenses made of Collamer have been approved by the FDA for implantation since 2000.
About STAAR Surgical
STAAR is a leader in the development, manufacture and marketing of minimally invasive ophthalmic products employing proprietary technologies. STAAR’s products are used by ophthalmic surgeons and include the Visian ICL, a tiny, flexible lens implanted to correct refractive errors, as well as innovative products designed to improve patient outcomes for cataracts and glaucoma. Manufactured in Switzerland by STAAR, the ICL is approved by the FDA for use in treating myopia, has received CE Marking and is sold in more than 40 countries. More information is available at http://www.staar.com.
Safe Harbor
All statements in this press release that are not statements of historical fact are forward-looking statements, including any statements about future development of accommodating Collamer lens designs or other plans, strategies, and objectives of management for future operations, 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.
STAAR’s current data on the accommodating properties of the Collamer material are based on the observations or reports of individual independent clinicians and have not been subjected to large scale clinical studies. 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. STAAR’s decision to pursue the development and marketing of accommodating Collamer lens designs will depend on positive results of initial feasibility studies, which are not complete. 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. Other risks and uncertainties include the negative effect of worldwide recession on demand for products used in elective procedures such as the Visian ICL, the possibility that negative publicity about complications of LASIK could reduce demand for all refractive procedures, our limited capital resources and limited access to financing, negative publicity resulting from past correspondence with the FDA and the integrity hold placed on our clinical activities, the challenge of managing foreign subsidiaries, the willingness of surgeons and patients to adopt a new product and procedure and other factors beyond our control, including the “risk factors” described in our Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. STAAR assumes no obligation to update these forward-looking statements to reflect future events or actual outcomes and does not intend to do so.
CONTACT: Investors, Doug Sherk, +1-415-896-6820, or Dahlia Bailey,
+1-415-896-5862, or Media, Chris Gale, +1-646-201-5431, all of EVC Group
for STAAR Surgical Company
Web site: http://www.staar.com/
