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.
