BUSINESS WIRE
Advanced Medical Optics (AMO) (NYSE:EYE) today announced its continued support and cooperation with the U.S. Food and Drug Administration (FDA) regarding the enhancement of product safety and effectiveness of contact lens care products.
AMO's presentation before the FDA's Ophthalmic Devices Panel of the Medical Devices Advisory Committee addressed several general issues regarding the safety and effectiveness of contact lens solutions and demonstrated that infection control is a complex issue that involves more than the formulation of the solution itself.
"Rub and rinse has been proven to improve effectiveness against Acanthamoeba and other microorganisms," said David Hansen, O.D., director of professional services, AMO. "We firmly believe that it should be an integral part of an effective contact lens hygiene regimen," he finished.
Safe use of contact lens care products depends heavily on the patient's compliance with labeled instructions for use. Specifically, the company emphasized that it is focused on the education of eye care professionals and patients on proper lens care compliance and that real-world testing of contact lens care products should be considered when evaluating product safety and efficacy.
"AMO is committed to protecting the ocular health of people who wear contact lenses and use lens care products," said Russ Trenary, executive vice president, global public policy and medical education at AMO. "We support safety measures that provide patients with appropriate steps for proper handling, disinfection and hygiene of contact lenses."
The company, which manufactures the COMPLETE(R) brand of eye care products, also shared information on ways to minimize the risk of infections such as Acanthamoeba keratitis among people who wear contact lenses and underscored the importance of proper handling, disinfection and hygiene when using contact lenses and contact lens products.
The company also addressed the FDA's interest in evaluating preclinical microbiology test methods to better serve as predictors of real world product performance. AMO supports establishing standards for testing the effectiveness of contact lens solutions in effectively disinfecting against a broad range of organisms in the best interest of the patients who use its products. "We look forward to collaborating with the FDA on the most effective and appropriate path forward because we share their interest in controlling infections," said Trenary. "Per our routine policy, we will comply with new FDA standards and/or labeling decisions and take any requested actions within the allotted timeframe."
About Advanced Medical Optics (AMO)
AMO is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver optimal vision and lifestyle experiences to patients of all ages. Products in the cataract line include monofocal intraocular lenses (IOLs), phacoemulsification systems, viscoelastics, and related products used in ocular surgery. AMO owns or has the rights to such product brands as Tecnis(R), Clariflex(R) and Sensar(R) IOLs; Sovereign(R), Sovereign(R) Compact and WhiteStar Signature(TM) phacoemulsification systems with WhiteStar(R) technology; Healon(R) viscoelastics and the Baerveldt(R) glaucoma shunt. Products in the refractive line include wavefront diagnostic devices, femtosecond lasers and associated patient interface devices; excimer laser vision correction systems and treatment cards, and refractive implants. AMO brands in the refractive business include iDesign(TM), iFS(TM), Star S4 IR(R), WaveScan Wavefront(R), Advanced CustomVue(TM), IntraLase(R), IntraLasik(R) and ReZoom(R), Tecnis(R) Multifocal and Verisyse(R) IOLs.
Products in the eye care line include disinfecting solutions, enzymatic cleaners, lens rewetting drops and artificial tears. Among the eye care product brands the company possesses are COMPLETE(R), COMPLETE(R) Blink-N-Clean(R), Consept(R)F, Consept(R) 1 Step, Oxysept(R) 1 Step, UltraCare(R), Ultrazyme(R), Total Care(TM) and blink(TM) branded products. AMO is based in Santa Ana, California, and employs approximately 4,000 worldwide. The company has operations in 24 countries and markets products in approximately 60 countries. For more information, visit the company's Website at www.amo-inc.com.
Forward-Looking Statements
This press release contains forward-looking statements about AMO, including statements by Mr. Hansen and Mr. Trenary and statements relating to AMO's product performance and patient compliance through education and labeling, and the industry's ability to develop standardized clinical and real world testing for disinfection against a broad range of microorganisms. All forward-looking statements in this press release represent AMO's judgment only as of the date of this press release. Actual results may differ from current expectations based on a number of factors. Therefore, the reader is cautioned not to rely on these forward-looking statements. AMO disclaims any intent or obligation to update these forward-looking statements. Additional information concerning these and other risk factors may be found in previous press releases issued by AMO and AMO's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in AMO's 2007 Form 10-K filed in March 2008. Copies of press releases and additional information about AMO are available at www.amo-inc.com.