Tougher Rules for Contact Lens Solutions Sought by FDA
Saturday, June 7th, 2008After Bausch & Lomb and Advanced Medical Optics contact lens solutions were linked to hundreds of eye infections the past two years, federal regulators are considering stricter testing requirements for the solutions. On June 6, 2008, the FDA outlined numerous proposals aimed at improving the safety of solutions used by as many as 34 million Americans who wear contact lenses.
Specifically, the FDA is considering new testing standards for contact solutions and updated labeling, including recommending that users gently rub their lenses during the cleaning process. On June 10, 2008 the agency will ask a panel of outside experts to weigh in on the ideas.
Multipurpose solutions have been on the market for a decade, all but replacing older systems that use several formulas to rinse and clean contacts. But the effectiveness of newer solutions has been questioned since Bausch & Lomb and Advanced Medical Optics separately pulled their products off the market in 2006 and 2007 after eye infection outbreaks.
The Centers for Disease Control and Prevention concluded in summer 2006 that Bausch & Lomb’s MoistureLoc solution played a key role in an outbreak of 180 Fusarium keratitis fungal infections, which can cause blindness.
A Bausch and Lomb spokesman said the company has been in discussions with FDA for over a year to ensure its remaining solution, Renu Multiplus, is used safely.
Like most other products on the market, Renu’s labeling does not advise patients to rub their contacts, an instruction which some eye doctors say helps keep lenses clean. FDA will ask its panel of eye care experts whether the recommendation should be a requirement. If the government favors that action, Bausch and Lomb said it would comply.
“We felt that if the solution was effective enough to pass FDA’s stringent requirements without rubbing then consumers should get that benefit,” said company spokesman Michael McDougall. “But should FDA decide a rub requirement is necessitated, we would have no problem with that.”
Advanced Medical Optics added a “rinse and rub” instruction to its latest solution, which it reformulated after last year’s withdrawal. Competing products from Alcon Inc. and other companies carry a “no rub” instruction.
Panelists also will debate whether contact solutions should be tested against a wider range of bacteria. That issue came to a head last year after CDC linked Advanced Medical Optics’ Complete Moistureplus solution to rare eye-infecting bacteria called Acanthamoeba keratitis. It is not among the bacteria and fungi FDA currently requires products be tested against.
Dr. Elmer Tu, professor of clinical ophthalmology at the University of Illinois at Chicago, said reports of the infection have continued despite AMO pulling its product off the market, suggesting competing products are susceptible to the same type of infection.
“Our hypothesis was that AMO happened to be the weakest solution of the group, but that doesn’t mean all the others are OK,” said Tu, who will present recommendations to FDA on June 10, 2008 on behalf of the American Academy of Ophthalmology. “If the outbreak is continuing and the current solutions are not working then there needs to be more research into how to reduce that risk.”