STAAR Surgical Company (NASDAQ:STAA) 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.