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FDA: No Plans To Recommend Action On Other Bausch Products

Other Bausch contact lens products not subject to heightened concern despite fungus infection is some users.

Only ReNu with Moisture Loc will be recalled. Other Bausch & Lomb products not subject to elevated concern.


WASHINGTON--3 May 2006--(Dow Jones)--The U.S. Food and Drug Administration on Wednesday said its advice to consumers that they not use a specific Bausch & Lomb Inc. (BOL) contact-lens solution remains the same, and the agency currently has no plans to recommend consumers quit using another Bausch product linked to reports of a serious eye infection.

Late Tuesday, the Centers for Disease Control and Prevention linked Bausch & Lomb's ReNu with MultiPlus solution in addition to ReNu with MoistureLoc, which the company pulled off the market after it was linked to cases of a serious eye infection that can cause blindness. Both the company and the FDA have recommended that consumers with existing ReNu with MoistureLoc contact-lens solution stop using it. The solution is used to store and clean contact lenses.

The CDC confirmed 86 cases of Fusarium keratitis infections, nine possible cases and is investigating 96 additional cases. The agency had complete information on 58 cases of the eye infections and, of those, 56 reported wearing contact lenses. Of those cases, 54 people reported using a Bausch & Lomb ReNu-brand contact-lens solution.

The CDC's most recent tally shows that 15 people reported using ReNu with MultiPlus - a product with roughly 40% of the contact lens solutions market - in addition to 32 cases of people who reported using ReNu with MoistureLoc. Seven people reported using an unspecified ReNu product.

Kristen Neese, an FDA spokeswoman, said in an email that the FDA's advice to consumers remains the same and that the breakdown of Bausch products linked to the fungal infections "continues to trend the same way."

On April 10, when the CDC first said it was investigating 109 reports of fungal infections, the agency had fully investigated 30 cases. Of those 30 cases, 26 people reported using a Bausch & Lomb ReNu brand contact-lens solution or a Bausch & Lomb-made generic but no information was released about the specific types of products. The May 2 update provided to Dow Jones by a CDC spokesperson was the first time the CDC released more specific product information.

FDA's Neese said the CDC has been giving FDA product breakdowns for the past few weeks and that the bulk of the eye infections remain linked to the MoistureLoc product. On April 10, Bausch voluntarily stopped shipments of ReNu with MoistureLoc, but a few days later asked retailers to remove the product from store shelves.

So far, health officials haven't determined a cause of the Fusarium infections, and there has been no definitive link made to Bausch & Lomb solutions. Health officials continue to investigate the company's Greenville, S.C., manufacturing plant where ReNu products are made.

In a press release issued Wednesday, Bausch & Lomb said the number of reports of ReNu MultiPlus among the 56 investigated cases was far below the product's market share, and that the product has an "excellent record of safety and effectiveness since it was introduced in 1997."

ReNu with MoistureLoc, in contrast, has a U.S. market share of less than 10%, which makes its heavy potential connection to confirmed fungal infections stand out.

"This disproportionate representation of the MoistureLoc formula in the CDC case reports is the reason Bausch & Lomb voluntarily withdrew MoistureLoc from the market while the investigation to determine the cause of these unusual infections continues," the company said.

Bausch & Lomb shares recently traded down 9.3%, or $4.54, to $44.21, and have fallen more than 30% since the end of March.

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