- The Washington Times - Wednesday, April 12, 2006

ROCHESTER, N.Y. (AP) — Bausch & Lomb Inc. scrambled to reassure investors yesterday as federal health officials try to unravel the mystery of whether the company’s newest contact lens solution is to blame for a flurry of potentially severe eye infections.

The source of an apparent spike in Fusarium keratitis infections linked to the ReNu with MoistureLoc contact lens solution remains unknown, and it could be weeks before an explanation is found, Bausch Chief Executive Officer Ronald L. Zarrella said yesterday.

The eye-care products maker halted U.S. shipments of the cleaning solution Monday while the Centers for Disease Control and Prevention investigates 109 reports of infection in patients in 17 states dating to June last year. The company already had cut off shipments from its Greenville, S.C., plant to the Far East in February after dozens of reported infections surfaced in Asia.

Federal health officials have found no direct link between ReNu and the infections, but many of the affected people had used the cleanser, which contains new-generation moisturizing and conditioning agents.

Company and government scientists have looked at more than 100 suspected factors, from chemical ingredients, batch tanks and production lines to packaging and shipping procedures, and “through all of that analysis, we haven’t found a correlation with anything,” Mr. Zarrella told analysts during a conference call.

“There’s been theories all the way from, ‘Has the tsunami … hurricanes and the effect of environmental factors created mold levels that are unprecedented?’” Mr. Zarrella said. “Right now, we’re trying to deal with the close-in factors of ensuring we don’t have a formula problem or a contamination problem in our manufacturing facilities. And nothing indicates that we do.”

Fusarium is commonly found in plant material and in soil in tropical and subtropical regions. Without 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, excessive discharge and increased sensitivity to light.

Bausch & Lomb began selling the brand in late 2004 and generated $45 million in U.S. sales last year — a small portion of its more than $2 billion in annual revenues.

The company, which also makes contact lenses, ophthalmic drugs and vision-correction surgical instruments, stopped short of recalling the solution, but merchants, led by Wal-Mart Stores Inc., began removing it from store shelves Tuesday. Analysts lowered their ratings and the stock took a tumble.

Woonsocket, R.I.-based CVS Corp. said it would pull ReNu from its 5,400 stores pending the outcome of an investigation into fungal infections linked to the product. CVS is the largest U.S. pharmacy by store count.

Walgreen Co. and Warwick, R.I.-based Brooks pharmacies also have pulled the solution from their shelves. Walgreen has stopped selling any ReNu product, spokeswoman Tiffani Bruce said.

After plunging 14.6 percent to a 2-year low Tuesday, the shares fell another $3.42, or 7 percent, to close at $45.61 yesterday on the New York Stock Exchange.

“We haven’t begun to estimate the ripple effect that all this negative publicity will have on other ReNu products or other geographical markets” such as China and Europe, where no such eye infections have been reported, Mr. Zarrella said.

The company will mount a vigorous brand-building campaign to try to stem the impact, he said, but the reverberations already were widening. Walgreen, the nation’s biggest drugstore chain by revenues, took the extra step of removing all ReNu brand products, and Moody’s Investors Service moved toward a ratings downgrade.

Bausch & Lomb also has been grappling with accounting troubles at its Brazilian and South Korean subsidiaries in recent months, and Mr. Zarrella said the company was unlikely to meet an April 30 deadline to file its annual report for 2005.

Soon after stopping shipments of ReNu in Singapore and Hong Kong in February, Bausch & Lomb said it began contacting corneal-treatment centers and eye-care professional groups in the United States to be on the lookout for a rise in Fusarium infections and re-emphasize sanitary lens-care habits among patients.

In some cases in which ophthalmologists tested lenses, lens cases and the ReNu cleanser, “the solutions remain sterile and the lenses and the lens cases are contaminated with Fusarium,” Mr. Zarrella said.

The St. Louis-based American Optometric Association alerted its 30,000 members to “the importance of reinforcing good wear and lens-care practices among their patients,” said Angela Panzarella, Bausch & Lomb’s corporate vice president for global vision care.

“You try to build in some margin of safety so the product will continue to perform, even with some extreme use,” she said. “But fundamentally, any product will fail if some reasonable care is not taken — if, for example, the patient doesn’t change the lens-care product and the lens case over time.”

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