Eye fungus outbreak puts makeup of lens cleaner under scrutiny

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Eye fungus outbreak puts makeup of lens cleaner under scrutiny

5/10/2006, 4:05 p.m. ET

By BEN DOBBIN

The Associated Press

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ROCHESTER, N.Y. (AP) — It's a cornea infection so rare that many eye

doctors have never seen a case, and so severe it can cause permanent

blindness. Yet in the past year, more than 100 Americans in 32

states — nearly all of them contact-lens wearers — have been

afflicted with Fusarium keratitis.

" There's no question what we're seeing here is not a trend or a

shift, it's something truly extraordinary, " said Dr. Arthur Epstein,

a Long Island optometrist who chairs the American Optometric

Association's contact lens and cornea section.

One month after the Centers for Disease Control and Prevention said

it was investigating a flurry of the fungal infections, government

health officials say it's still too early to say whether Bausch &

Lomb Inc.'s newest lens-care cleaner, ReNu with MoistureLoc

MultiPurpose Solution, is responsible.

But some eye-care professionals view the 1 1/2-year-old brand and

its unique disinfecting and moisturizing agents as the most logical

explanation for the outbreak that surfaced last fall in the Far East

and most recently showed up in Europe. At least eight U.S. patients

have required cornea transplants.

" For this level of infections to be occurring, the disinfection

system has to be failing, " Epstein said. " There's a significant

amount of research over the past two years that suggests that the

disinfectant is being absorbed into the lens where it's ineffective.

" In a bottle, that solution is very potent, works perfectly, but the

problem is when you take it out of a bottle, squirt it into a lens

case and put a contact lens in. Depending on the lens, the killing

ability of the disinfectant goes down steadily ... and the Fusarium

fungus takes the longest to kill. "

While warning against a rush to judgment, Bausch & Lomb's chief

scientific officer, Praveen Tyle, affirmed Thursday that " we are

looking more and more closely to patient habits and whether, when

they're using MoistureLoc, they're more likely to get an infection

compared with other products. "

Extensive federal inspections of the factory in Greenville, S.C.,

where MoistureLoc was made for U.S. and several Asian markets before

sales were halted a month ago, have not turned up evidence of

contamination.

While microbiologic tests could take weeks to analyze, " one thing we

are very close to deleting as a possibility is a widespread

contamination in our plant, " Tyle said.

No infections have been reported in Japan or Canada, where

MoistureLoc has never been sold, and infections dwindled in

Singapore after MoistureLoc was pulled off shelves there in

February, Tyle noted.

If MoistureLoc is implicated, he added, " the decision we really have

to make is, `Can we bring this product back in its current forms in

these markets, or do we have to tweak something ... in the formula

and then bring back the tweaked formula?' "

The CDC said this week the number of confirmed infections had edged

up to 106, and an additional 92 reports of infection were under

investigation.

Of the 93 fully analyzed cases involving contact lens users, 59

patients, or 63 percent, reported using MoistureLoc and 19 others,

or 20 percent, said they used an older, more popular Bausch & Lomb

solution called ReNu MultiPlus. Seven said they used cleaners made

by Alcon Inc. and Advanced Medical Optics Inc.

" Patients may not be able to distinguish between MoistureLoc and

MultiPlus — the packaging and labeling is very similar, " Tyle

said. " We don't believe that MultiPlus is the cause here. "

But Banc of America Securities analyst Maris thinks " the most

conservative fix to the problem during the investigation still seems

to be to suspend sales " of the entire ReNu line made in Greenville.

" It's hard for us to speculate exactly what the cause is, " said Dr.

L. Abbott, a professor of ophthalmology at the University of

California San Francisco. " But certainly when you look at the

statistics, suspicion is very high for these products. "

Of the more than 30 million Americans who wear contact lenses,

nearly 11 million use MultiPlus, which was launched a decade ago.

Another 2.3 million people use MoistureLoc, which was introduced in

late 2004 and accounted for $45 million in U.S. sales last year.

Bausch & Lomb also makes contact lenses, ophthalmic drugs and vision-

correction surgical instruments and generates more than $2 billion

in annual revenues.

Its shares, which have plunged 34 percent this year, fell 13 cents

to $44.71 in afternoon trading on the New York Stock Exchange, at

the low end of their 52-week range of $40.75 to $87.89.

The Fusarium fungus is commonly found in plant material and soil in

tropical and subtropical areas. Without eyedrop treatment, which can

last two to three months, the infection can scar the cornea and

blind its victims.

Symptoms can include blurry vision, pain or redness, increased

sensitivity to light and excessive discharge from the eye. It is not

transmitted from person to person.

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On the Net:

http://www.bausch.com

http://www.fda.gov/