Fusarium frustration

June 1, 2006

As investigators search for the source of an unusual outbreak of Fusarium keratitis cases among contact lens wearers, the number of confirmed cases continues to climb.

Of the 98 confirmed cases for which the CDC had complete data, all but five patients wore contact lenses and used contact lens solution, and 59 patients reported using Bausch & Lomb's ReNu with MoistureLoc Multi-Purpose Solution, a fact that the company said in a May 3 statement is "significantly and disproportionately higher than its U.S. market share of less than 10% . . ." In another 19% of confirmed, fully investigated cases, patients reported using Bausch & Lomb's ReNu with MultiPlus, while another nine patients reported using "any unspecified B&L ReNu."

The CDC stressed that it is too early in the investigation to identify any particular solution as being responsible for the outbreak. However, Bausch & Lomb's MoistureLoc product is consistently linked in 50% to 60% of confirmed cases, the CDC said.

While FDA officials comb through the Greenville, SC, plant that manufactures ReNu with MoistureLoc for distribution throughout the United States and parts of Asia, they have revealed little of their investigation.

However, the FDA said it continues to show interest in the MoistureLoc product because of the growing number of confirmed cases in which that product was used, and no further recalls were warranted. (See "Health officials scramble to find source of fungal keratitis cases," Ophthalmology Times, May 15, 2006).

"The FDA continues to work with the CDC to investigate the Fusarium keratitis infections and will determine whether or not further action needs to be taken," the agency said in a May 5 update.

Outside the United States

Meanwhile, cases of Fusarium keratitis are being reported in Brazil and in Europe, in addition to those already under investigation in Singapore, Hong Kong, Malaysia, and the United States.