FDA considers stricter rules for contact lens solutions

Washington, DC-The FDA is considering changing requirements for contact lens cleaning solutions after infections in recent years prompted product recalls, hundreds of lawsuits, and cornea transplants for more than 100 patients.

In a daylong hearing on June 10, members of the agency's Ophthalmic Devices Panel discussed issues relating to patient labeling and use, transient corneal staining, preservative depletion, silicone hydrogel lenses, and biocompatibility of lenses with certain multipurpose solutions. The panel listened to presentations by outside researchers and clinicians, many of whom endorsed a "rub-and-rinse" regimen when cleaning contact lenses, even though "no-rub" formulas have been approved by the FDA for years and had become popular with consumers.

There was no vote, but the FDA staff will take the discussion under consideration, according to Karen Riley, a spokeswoman for the FDA's Center for Devices and Radiological Health.

Outbreak

Beginning in April 2006, 180 cases of suspected Fusarium keratitis were reported in 36 states and U.S. territories; 30 cases required corneal transplants. Many of these usually rare cases were linked to use of Bausch & Lomb's ReNu with MoistureLoc contact lens solution, which the company permanently recalled in May 2006. The company attributed the Fusarium keratitis cases to a combination of surfactants that, in some circumstances, allowed the fungus to grow in contact lens cases.

Also in May 2006, researchers at the Illinois Department of Public Health said they had begun to see an increase in Acanthamoeba keratitis cases over the previous three years. The Centers for Disease Control and Prevention (CDC) later found 158 culture-confirmed cases of Acanthamoeba keratitis associated with use of a contact lens solution; in 28% of these cases, cornea transplant was performed or planned. The CDC found more than 54% of cases were linked to use of Advanced Medical Optics' (AMO's) Complete MoisturePlus solution, and the company began a worldwide recall May 25, 2007.

Expanding tests

Before approving a contact lens solution for the market, the FDA tests for Pseudomonas aeruginosa, Staphylococcusaureus, Esherichiacoli, Candidaalbicans, and Aspergillus niger. In light of these fungal outbreaks, the FDA should add Acanthamoeba to that list, Elmer Y. Tu, MD, of the University of Illinois at Chicago Eye and Ear Infirmary, told the panel. Dr. Tu spoke on behalf of the American Academy of Ophthalmology, American Society of Cataract and Refractive Surgery, the Contact Lens Association of Ophthalmologists, and The Cornea Society. His presentation was one of 17 posted on the FDA's Web site, http://www.fda.gov/.

"Testing requirements should be updated to ensure products are effective against a more diverse and representative set of infectious organisms, including Acanthamoeba," Dr. Tu said. "At the same time, tests currently required should be continued because of their historic use and for comparison purposes."

Dr. Tu told the panel that although advances have been made in the disinfecting regimen, the use of extended-wear contact lenses, reduced tear exchange under the lens, environmental factors, and poor consumer hygiene all contribute to infection. He advocated additional research into each of those factors.

Dr. Tu said pre-clinical testing should more closely replicate consumers' habits and lifestyles when determining the effectiveness of cleaning solutions. Expanding the solution tests will not necessarily prevent another outbreak of eye infections, he noted.

"However, it will increase overall safety for contact lens wearers, especially against those organisms most commonly responsible for contact lens-related infection," he said.