Attorney Daily - Your source for the most important legal news

Based upon data from a study published in the November 2008 issue of Archives of Ophthalmology, Renu with Moistureloc, manufactured by Bausch & Lomb, a contact lens solution that was implicated in an epidemic of the eye infection Fusarium keratitis between 2004 and 2006 was likely due to a reduction in the solution’s antifungal activity because of exposure to prolonged temperature increase.

In August 2004, Bausch & Lomb introduced ReNu with MoistureLoc, a contact lens solution that contains a unique antimicrobial agent. The solution was associated with cases of Fusarium keratitis, according to U.S. government reports, since March 2006. Eventually there were 154 confirmed cases identified in the United States of this condition characterized by inflammation of the cornea (keratitis). Bausch & Lomb investigators acknowledged that all original cases appear to be related to ReNu with MoistureLoc produced in their Greenville, South Carolina plant.

In 2006, the FDA inspected the Greenville facility and cited Bausch & Lomb for poorly controlling temperature in the production, storage and transport of products from this plant. Researchers further studied the effects of temperature on the growth of the Fusarium fungus by analyzing five contact solutions in addition to ReNu with MoistureLoc. The researchers explain that, Two bottles of each solution were separately stored at room temperature and 60 degrees Celsius [140 degrees Fahrenheit] for four weeks, serially diluted and then tested for their ability to inhibit growth of 11 Fusarium isolates (seven of which were associated with the keratitis epidemic).

Bausch & Lomb permanently removed its contact lens solution Renu with MoistureLoc from the market on May 15, 2006 due to an outbreak of extremely serious fungal eye infections called fungal keratitis, caused by the fusarium fungus. Bausch & Lomb had suspended shipments in April and asked retailers to stop selling the product. In February 2006, the company stopped selling ReNu with MoistureLoc in several Asian countries.  The outbreak affected hundreds of contact lens wearers worldwide. Many victims of ReNu with MoistureLoc suffered partial or complete loss of vision in the affected eye(s) and were forced to undergo cornea transplantation surgery, with some requiring multiple cornea surgeries.

ReNu with MoistureLoc showed the greatest decline in anti-fungal activity after the 60-degree storage period, while Clear Care and ReNu MultiPlus demonstrated the smallest decline. The authors also specifically analyzed the strains of Fusarium that were linked to the keratitis epidemic. In addition, the authors of the study found that when stored at room temperature, ReNu with MoistureLoc allowed fungal growth in 27 of 84 different blends of isolates grown in different solutions and at different levels of dilution. When stored at 140 degrees Farenheit, the solution allowed fungal growth in 67 of 84 of these combinations.

After 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.”