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"Our patented Collamer material is similar to the eye's naturalcrystalline lens in its ability to refract light, its flexibility and highwater content - all characteristics necessary for high quality visualoutcomes," 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 investigatethe baseline accommodative ability of our Collamer lens. We have reviewedpublished clinical data by Dr. Liz Davis and Dr. Liviu Saimovici reporting theaccommodative properties of our Collamer Single Piece Lens as well as feedbackfrom ophthalmologists involved in other clinical comparisons where the ThreePiece Collamer lens showed accommodative properties."
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To explore the accommodative properties of Collamer a phased approach willbe used. The members of the CAST team will begin Phase One with the launch ofthe Collamer Aspheric Single Piece Lens. The initial goal is to collectbaseline accommodative data on the performance of the lens. Each member willcollect near and distance visual acuity data from their patients implantedwith the Collamer lens. STAAR's research and development team has engineeredchanges to the current lens to maximize the current levels of accommodation.During Phase Two CAST will evaluate these design changes against the baselineaccommodative data collected from Phase One. The Company does not currentlybelieve that these changes would require supplemental premarket approval fromthe FDA, which means the redesigned lens could be available during 2009. Oncedata is completed the Company will decide whether to apply for anaccommodative labeling claim from the FDA. Phase Three will involve a newlydesigned Collamer Lens which would require a full clinical study andsubmission to the FDA for approval to commercialize the device and makeaccommodative 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 thatprovides an alternative to LASIK for refractive patients. Dr. Paul Dougherty,who is a member of CAST, appeared on the November 14th airing of a nationallysyndicated show, "The Doctors." On the program Dr. Dougherty was confrontedwith a patient who had worn glasses since the age of six and had been told byother ophthalmologists that LASIK was not an option. The Visian ICL procedurewas 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 orHigh Quality Vision. The day the segment aired the number of visitors to theVisian ICL website increased by tenfold. The segment can be viewed byvisiting: 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 purecollagen copolymer. Collamer is composed of a poly-HEMA based copolymer, asmall amount of collagen and a UV-absorbing chromophore (light absorbingchemical). When fully hydrated, the Collamer lens material possesses a highwater content concentrated at the surface of the lens. The distribution ofthe water content (the bulk at the lens's surface) creates an anti-reflectiveinterface in Collamer lenses. Other characteristics of the Collamer lens areits low levels of aberrations, biocompatibility and bio-adhesive properties.These unique features make Collamer an ideal optic material and highlysuitable for an accommodative lens. STAAR's formula and processes for makingCollamer are protected by patents. Lenses made of Collamer have been approvedby the FDA for implantation since 2000.
About STAAR Surgical
STAAR is a leader in the development, manufacture and marketing ofminimally invasive ophthalmic products employing proprietary technologies.STAAR's products are used by ophthalmic surgeons and include the Visian ICL, atiny, flexible lens implanted to correct refractive errors, as well asinnovative products designed to improve patient outcomes for cataracts andglaucoma. Manufactured in Switzerland by STAAR, the ICL is approved by the FDAfor use in treating myopia, has received CE Marking and is sold in more than40 countries. More information is available at http://www.staar.com.
Safe Harbor
All statements in this press release that are not statements of historicalfact are forward-looking statements, including any statements about futuredevelopment of accommodating Collamer lens designs or other plans, strategies,and objectives of management for future operations, statements of belief andany statements of assumptions underlying any of the foregoing. Thesestatements are based on expectations and assumptions as of the date of thispress release and are subject to numerous risks and uncertainties, which couldcause actual results to differ materially from those described in the forward-looking statements.
STAAR's current data on the accommodating properties of the Collamermaterial are based on the observations or reports of individual independentclinicians and have not been subjected to large scale clinical studies. STAARcannot assure that its further research will support a claim that either itscurrent Collamer lenses or future designs restore the eye's ability toaccommodate. If clinical research does not support these claims, or supportsonly a narrow range of accommodation, STAAR's Collamer accommodation projectmay not result in increased sales. STAAR's decision to pursue the developmentand marketing of accommodating Collamer lens designs will depend on positiveresults of initial feasibility studies, which are not complete. New lensdesigns may require clinical research studies and applying for the FDA'spremarket approval, which are expensive and could result in delay or denial ofapproval. Other risks and uncertainties include the negative effect ofworldwide recession on demand for products used in elective procedures such asthe Visian ICL, the possibility that negative publicity about complications ofLASIK could reduce demand for all refractive procedures, our limited capitalresources and limited access to financing, negative publicity resulting frompast correspondence with the FDA and the integrity hold placed on our clinicalactivities, the challenge of managing foreign subsidiaries, the willingness ofsurgeons and patients to adopt a new product and procedure and other factorsbeyond our control, including the "risk factors" described in our AnnualReport on Form 10-K and Quarterly Report on Form 10-Q filed with theSecurities and Exchange Commission. STAAR assumes no obligation to updatethese forward-looking statements to reflect future events or actual outcomesand does not intend to do so.CONTACT: Investors Media EVC Group EVC Group Doug Sherk, 415-896-6820 Chris Gale, 646-201-5431 Dahlia Bailey, 415-896-5862
SOURCE STAAR Surgical Company
