Company Advocates Rub and Rinse Regimen
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® 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.
