Drug Products

Source of Fusarium Keratitis Fungus Still a Mystery

According to an article in the NY Times, a researcher hired by Bausch & Lomb has published a report indicating that the infection is not coming from the eye contact solution. The FDA and CDC have not commented directly on his findings. FDA officials declined to comment yesterday on Mr. Geiser’s assessment. But the agency’s Web site posted an update saying that while it continued to confirm cases of Fusarium infections associated with products other than ReNu With MoistureLoc, “Our interest in the MoistureLoc product is based on the disproportionate number of cases of Fusarium keratitis associated with ReNu With MoistureLoc compared to the overall product market share.”
As of yesterday, the federal Centers for Disease Control and Prevention in Atlanta had received 195 reports of Fusarium eye infections occurring in the United States since last June, 102 of which had been confirmed in follow-up investigations. “At this point, it is too early in the investigation to say whether a particular product or solution may be responsible for the outbreak,” the C.D.C. said.

Bausch & Lomb Fungus Enters Europe

New cases of the fusarium keratitis fungus have been confirmed in Europe. The cases represent the first time the company has acknowledged European incidents of the infection, which has struck Bausch solution users in Asia and the U.S. The outbreak has led the company to halt shipments of one of its products, ReNu with MoistureLoc, in several countries and to scrutinize a manufacturing plant in South Carolina for a possible explanation of the infection.

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Sites Set on Bausch & Lomb

As the days pass, the news continues to get worse for Bausch & Lomb. Initially, the company asked consumers to stop using one of their products, ReNu with MoistureLoc. In the intervening weeks, company execs tried to intimate that if there was a problem at all, it was restricted to the one product. Now that the CDC report comes out we know otherwise. Let’s take a look a the CDC numbers:
Fusarium Keratitis Outbreak among contact users:
56 confirmed cases
32 – B & L ReNu with Moisture Loc
15 – B & L ReNu with MultiPlus
7 – B & L ReNu (unspecified)
6 – other company brands
-Source US CDC

More Tears for Bausch & Lomb

In a company press statement issued in the middle of the night, Bausch & Lomb now reveal that additional cases of fusarium keratitis have been linked to the company’s ReNu products. According to a Market Watch report, “In an overnight release, Bausch & Lomb said “that a review by the U.S. Centers for Disease Control and Prevention had found reported cases of fungal keratitis among contact-lens wearers who used not only ReNu with MoistureLoc but also another popular ReNu product, ReNu MultiPlus solution.”

Why Bausch & Lomb Withdrew ReNu from the Market

The relationship between the recent outbreak of fusarium keratitis and Bausch & Lomb’s ReNu eye contact solution is becoming clearer as the CDC and the FDA continues its investigation. According to an article in Reuters, “The 57 percent share of cases preliminarily reported for the company’s MoistureLoc formula is significantly and disproportionately higher than its U.S. market share of less than 10 percent,” the company said in a statement.
“This disproportionate representation of MoistureLoc formula in the CDC case reports is the reason Bausch & Lomb voluntarily withdrew … from the market while the investigation to determine the cause of these unusual infections continue,” the company said.

Bausch & Lomb Says Initial Fusarium Findings Require More Investigation

In reaction to the CDC’s initial report on the fusarium fungus linked to Bausch & Lomb’s ReNu, the company has stated that the report requires further investigation. Now, we don’t know if this public relations obfuscation or the data reported thus far really requires further review. We do know that this fungus can cause blindness and/or serious eye damage if it’s not treated in a timely fashion.