Medical Device Daily Associate
Bausch & Lomb (B&L; Rochester, New York) reported that it is temporarily suspending U.S. shipments of ReNu with MoistureLoc contact lens care products made at its Greenville, South Carolina, facility in order, it said, “to facilitate the further investigation of reports of fungal keratitis infections among contact lens wearers in the United States.“
The suspension follows the release of a report by the U.S. Centers for Disease Control & Prevention (CDC; Atlanta) that it is reviewing reports of 109 cases in 17 states since June 2005 of suspected fungal keratitis, which is caused by the fusarium fungus.
The CDC said that the majority of cases have yet to be reviewed, but of the 30 cases reviewed so far, 28 involved contact lens wearers. Twenty-one reported using ReNu contact lens care products and five reported using a combination of ReNu and products manufactured by Advanced Medical Optics (Santa Ana, California) and Alcon (Fort Worth, Texas).
An estimated 30 million Americans wear soft contact lenses, the CDC noted.
“The CDC data released today are both troubling and perplexing, as there is an apparent disproportionate representation of U.S.-manufactured ReNu with MoistureLoc in the underlying data,“ said Ronald Zarella, B&L CEO and chairman, in a statement. He said the source of the infections has not been determined and that the available scientific evidence “does not establish any type of ReNu solution as a cause.“
The fungus rarely affects contact lens users, and the surge in reported cases has raised alarm at centers across the country, including cornea specialists at Bascom Palmer Eye Institute of the University of Miami's Miller School of Medicine (Miami, Florida)who reported their concerns last week (Medical Device Daily, Apr. 5, 2006).
Soft contact lens use has been the only identified risk factor in the majority of the cases seen between January and March 2006 at the institute's facility, where it said 21 cases have been identified, 12 among contact lens users.
Between 2000 and 2005, the average number of fusarium keratitis cases was 21 per year. Usually, less than 2% of these cases have been in contact lens users, the institute said.
The fungus is commonly found in plant material and soil in tropical and subtropical areas. Singapore health officials noticed an increase in reports of infection in January and discovered 39 cases involving contact lens users from 2005 to February of this year. Cases have also been reported in Malaysia and Hong Kong.
In February, B&L halted sales of its ReNu contact lens solution in Singapore and Hong Kong.
Without treatment, which can last two to three months, the infection can scar the cornea and blind its victims. Eight U.S. patients have required cornea transplants, the CDC reported.
B&L said it has been collaborating with the FDA, the CDC, major eye centers and health authorities to determine if the reports represent an increase in the historical incidence of these infections and determine the root cause.
The company had previously noted that many of the reported cases in Asia involved examples of poor patient compliance with lens care and contact lens wear, including wearing expired lenses and re-using daily disposable contact lenses. It urged contact lens wearers to follow good hygiene and proper lens care practices to prevent infection and warned against the use of unregulated “knock-offs.“
The company stressed that this suspension does not affect any other B&L products.
Daniel Schultz, MD, director of the FDA's Center for Devices and Radiological Health, said it was too early to determine if B&L's solution was the cause of the infections. Both the FDA and CDC are investigating the growing number of reports of infection by the fungus.
“We are relatively early in this investigation. It may be we will find this particular product does not have an association. We may find a strong association,“ Schultz told reporters, adding that the company's decision to stop shipments was “a very appropriate and responsible action.“
While the company is halting shipments, stores can continue to sell Renu until supplies run out, Schultz said.
The concerns began on March 8 when a New Jersey ophthalmologist called the CDC to say that he had seen three patients in the previous three months who were suffering from fusarium keratitis.
The infections are rare but are more likely to occur in the South. That so many cases have been found in New York and New Jersey caused particular concern, Schultz said.
Some analysts said that the suspension could hurt the company at least in the short-term.
Med-tech analyst Joanne Wuensch of investment banking firm Harris Nesbitt (New York) in a research report wrote that the product could be absent from the U.S. market until the end of the year.
“We estimate each $10 million in lost lens care sales reduces EPS by roughly 2 cents,“ she said, adding that still uncertain “is the collateral damage to other Bausch & Lomb brands.“
The company said that the product generated sales of about $45 million in the U.S. in 2005, and that it already had reported that the situation is expected to reduce its 1Q vision care revenues in Asia by as much as $10 million vs. internal expectations.