As reported by the Rochester Democrat and Chronicle, May 4, 2006.

Concerns Spread to More B&L Products

Infections Hit Users of Two Other ReNu Solutions

By Nishad Majmudar

Concerns about the safety of Bausch & Lomb Inc.'s ReNu with MoistureLoc have now spread to the company's other contact lens solutions.

New data from the U.S. Centers for Disease Control and Prevention indicate that ReNu with MoistureLoc might not be the only B&L product used by contact lens wearers who contracted Fusarium keratitis, a rare fungal eye infection that can damage the cornea.

U.S. health officials said 32 of 58 people with fungal infections used MoistureLoc, which B&L pulled from the market April 10, while 15 more used ReNu MultiPlus and seven used other ReNu brands.

The news prompted B&L's stock to drop almost 10 percent Wednesday and close at $43.97. Volume was heavy, with more than 13million shares changing hands.

In a printed statement, the Rochester company said it would consult with the CDC Wednesday afternoon in a "previously scheduled meeting" to review the latest information from investigations of the eye infections, and it added that the new data "should be placed in proper context."

"It would be expected that the distribution of lens care products associated with these cases would be roughly proportional to the products' relative market share," the statement read. "In the small sample of cases the CDC has analyzed to date, the 27 percent representation of ReNu MultiPlus solution is well below its approximate 40 percent market share."

In a video statement posted on the company's Web site Wednesday afternoon, B&L Chief Executive Ronald Zarrella added: "despite an incredible effort by the company, the FDA, CDC and experts around the world, we don't yet know why this fungus is causing infections in contact lens wearers. We're looking at every possibility. I believe we've taken the appropriate action at every step of the way."

B&L suspended U.S. sales of ReNu with MoistureLoc on April 10 to determine whether the product was causing the infections, which are rare among contact lens wearers. All of B&L's lens care products sold in the United States are manufactured at its plant in Greenville, S.C.

Dr. William Ehlers, a corneal specialist at the University of Connecticut and an official with the American Academy of Ophthalmology, said he and the academy are standing by the ReNu MultiPlus solution until more information comes to light.

"I am not advising people at this time to not use other B&L products," Ehlers said. "Clearly this is a developing situation and there are more cases under investigation than have been reported. As the numbers change, that position may change."

One analyst said the latest news raised new questions about whether B&L would expand its recall to cover other ReNu-brand contact lens solutions.

"Without an overwhelming majority (of CDC-reported cases) leaning to MoistureLoc, we believe (B&L's) rationale for removing MoistureLoc and not all of ReNu is no longer intact and the risk of a larger recall is increasing," Bank of America Corp. analyst David Maris wrote in a research note Wednesday.

"(B&L's) decision to pull one product and offer coupons for the other may have not been the most prudent if all of (the company's) U.S.-manufactured lens care products are implicated."

Analyst Milton Hsu of Bear Stearns & Co. Inc. in New York said in a research note that it is plausible that the CDC data are skewed toward B&L's products because of the negative publicity specifically surrounding the MoistureLoc product.

But, he noted, "this may be irrelevant, considering that consumer perception of safety is paramount and the ReNu brand equity continues to sustain damage, given the lack of an identifiable cause and the CDC statistics to date."