NEWS UPDATE: On May 24, 2006, THKO filed a Federal Class Action Lawsuit against Bausch & Lomb in the District Court for the Southern Distict of Florida. THKO is seeking approval from the Court to proceed with a class consisting of all individuals who obtained eye infections as a result of using ReNu MoistureLoc lens solution. However, THKO represents a large number of clients with serious injuries (from corneal ulceration to total blindness) sustained as a result of using the defective ReNu solution and has since filed many individual lawsuits on their behalf. With the acquisition of a leading group of experts in the fields of optometry and opthalmology, we are anxious to seek justice for our clients.

Click here for a copy of the Federal Class Action Lawsuit against Bausch & Lomb in the District Court for the Southern Distict of Florida

Lens Case Bausch & Lomb Solution Recall
Exposes Risks for Eye Infections
Studies Pointed to Problems
As Long as Nine Years Ago;
Now, Industry Re-evaluates
The Role of 'Corneal Staining'
By SYLVIA PAGÁN WESTPHAL
July 26, 2006; Page A1

Two months ago, Bausch & Lomb Inc. issued a global recall of a new multipurpose contact-lens solution after it was linked to serious fungal eye infections in the U.S. and Asia. Within weeks, the company's U.S. market share for lens solutions dropped to 29%, down from 41%.

Bausch explained that under certain "unique circumstances" -- such as when people left cases open and let the product evaporate -- ReNu with MoistureLoc created an environment that allowed the fusarium fungus to thrive.

But to some researchers, the ReNu fallout didn't come as a surprise. As long as nine years ago, tests performed by doctors and eye clinicians had suggested that multipurpose solutions might be associated with certain health risks.

Manufacturers of contact-lens solutions downplayed the concerns, saying their products were safe and effective when properly used. Market leader Bausch, in particular, took the offensive against researchers who linked its solutions to possible safety issues.

Today, there is mounting concern that multipurpose solutions -- so named because they are designed for cleaning, disinfecting and storing soft contact lenses -- may indeed be contributing to dangerous eye infections.

The fusarium scare has prompted the Food and Drug Administration, which regulates the solutions, to re-evaluate its current testing methods. Marketers are taking action, too. "It was a wake-up call," says Lynn Lasswell, director of eye care clinical research at Advanced Medical Optics Inc., maker of multipurpose solution brands including Complete MoisturePLUS. "We're certainly looking at our testing methods to make them more robust."

Some academic and industry researchers also fear that certain solution brands, when used with certain contact lenses, may cause damage to the surface of the eye. This phenomenon is known as "corneal staining." Though the premise is still unproved, some researchers think that corneal staining could predispose some people to infection.

Hints of problems with multipurpose solutions began to emerge in the late 1990s. In 1999, Indiana State University microbiologist Kathleen Dannelly added Pseudomonas aeruginosa -- an organism that causes eye infections -- to five popular contact-lens solutions. She wanted to test the solutions under conditions that mimicked an infection, using higher amounts of bacteria than industry testing standards require.

Dr. Dannelly found that Bausch's ReNu MultiPlus, the company's leading solution at the time, didn't kill the bacteria as well as the other brands. The results of the independently funded study appeared in the trade journal Contact Lens Spectrum in 2000.

Bausch wasn't pleased. In a letter, former corporate vice president Alan P. Dozier complained to the university about the study's methodology. He said that two studies, one of them conducted by Bausch, showed ReNu to be as effective as other brands. Mr. Dozier requested "an immediate retraction" of the published article, arguing the company had to spend "significant time and resources" defending its products with doctors and patients. His request was denied, and the university stood by Dr. Dannelly's study.

Several years later, studies performed by Alcon Inc. and published in the journal Contact Lens and Anterior Eye tested four different multipurpose solution brands under conditions that simulated regular use by consumers. Skipping the rinsing and rubbing steps, for instance, which many people do, made the solutions -- including Alcon's -- less able to kill several test organisms such as the fusarium fungus. Alcon declined to comment on the results of these studies, but maintains, as other manufacturers do, that its solutions are safe and effective for consumers.

At the University of Texas Southwestern in Dallas, researchers found in 2003 that multipurpose solutions can increase the binding of bacteria to the cells of the cornea. This, they wrote, "might potentially contribute inadvertently to increased risk" for eye infections.

Then, in 2005, New York optometrist Arthur Epstein decided to try an informal experiment. He left several cases of contact lenses soaking in Bausch's new ReNu with MoistureLoc.

A week later he opened the cases and, to his surprise, several of the lenses "were clearly covered with what appeared to be fungus," says Dr. Epstein, who concluded it was a "fluke" and did not immediately contact Bausch.

Dr. Epstein, who is also a spokesman for the American Optometric Association, has in recent years consulted or lectured for most eye-care companies -- including Alcon and Bausch.

He says he has been able to repeatedly grow fusarium and other microbes in lenses soaked for days in ReNu with MoistureLoc. He says he alerted the company to his findings in April, when questions about the fusarium outbreak emerged. He says he provided information about his methodology.

Bausch says it asked for, and did not receive, access to Dr. Epstein's methodology and that it would be "impossible to comment responsibly" on unknown data.

The company notes that during its own investigation into the fusarium outbreak, it added the fungus to lenses and soaked them in solution. Up to 28 days later, it says, no growth was detected.

Eye infections among contact-lens users are still considered to be relatively uncommon. Their incidence is thought to be about 5 cases per 10,000 users a year. But with about 125 million contact-lens users world-wide, this implies that more than 60,000 people a year will develop an infection.

Most of the cases associated with the fusarium outbreak involved ReNu with MoistureLoc. The Centers for Disease Control and Prevention confirmed 125 U.S. cases affecting contact-lens wearers. Of those, 118 patients provided information about what solutions they had used. Seventy-five, or 64%, of patients had used only ReNu with MoistureLoc; 14, or 12%, used ReNu with MoistureLoc along with other products; and another eight, or 7%, used unspecified Bausch solutions.

The CDC concluded there was no statistically significant infection link to any other brand of solution.

Bausch is one of the major players in the $6.3 billion contact lens and lens-care market. In 2004, the last year in which the company reported full earnings, Bausch had revenues of $2.23 billion, of which contact-lens care contributed 23%.

Once headlines surfaced linking the fungal infections to Bausch's ReNu solution in early April this year, the company's shares took a hit. The stock traded above $60 per share during the early months of 2006 but shares plunged and have not recovered. In 4 p.m. composite trading on the New York Stock Exchange, they rose 44 cents, to $47.91.

Solution manufacturers have recently revamped their marketing efforts to reassure wary consumers that their products are safe. For example, AMO's Web site features a banner titled "important message regarding safety of multipurpose solutions" which takes users to a company letter touting its solution's "excellent safety record." Alcon's "look into it" Web site has a prominent sidebar discussing fungal eye infections and the ReNu recall. The Web site goes on to describe how not all contact-lens solutions are created equal.

Multipurpose solutions came onto the market in the mid-1980s, replacing more complicated regimens that required consumers to use different agents for cleaning, disinfecting and storing lenses. The convenient new solutions were touted as being able to kill dangerous microbes that can cause infection.

Consumer behaviors, including poor hygiene and wearing lenses overnight, have generally been considered the major risk factors for infection. In 2004, Elisabeth Cohen and her team at Wills Eye Hospital in Pennsylvania published a study that challenged this theory. Of 70 patients with eye infections, 30% said they had strictly followed instructions for contact-lens care. The team's conclusion: Even among careful users of soft contact lenses, multipurpose solutions may not be enough to stave off infections.

One concern among researchers is that current FDA-mandated tests do little to mimic real-world use of contact-lens solutions.

During the FDA approval process, a handful of sample organisms -- such as the yeast Candida albicans, the fungus Fusarium solani and others -- are added individually to a solution. Hours or days later, depending on the test, the solution is analyzed for its ability to kill the microbes. Most solutions pass the test and manufacturers insist that, when used according to directions, these solutions are highly effective.

The FDA does not, however, ask manufacturers to measure the disinfecting ability of a solution after used lenses have been stored in it for days -- a common practice by people who take breaks from their lenses.

The fusarium outbreak has caused companies in the industry to re-examine the kinds of internal tests they perform. AMO, for instance, is thinking of adding testing organisms that are currently not required by the FDA.

"We have naively believed the FDA standards for disinfecting efficacy were sufficiently robust to prevent something like this from happening," says Dr. Epstein. "We need to now re-examine those beliefs."

Kristen Neese, a spokeswoman for the FDA, says that the International Organization for Standardization -- whose testing guidelines the FDA imposes on makers of contact-lens solutions -- is in the midst of revising them.

Until the highly publicized fusarium outbreak, consumers knew little about the possible pitfalls of multipurpose solutions. "People assume you squirt some of the stuff in there and it's safe," says Indiana State's Dr. Dannelly.

As the Bausch recall underscores, there are big differences between products -- and variables whose effects are unknown. For instance, ReNu with MoistureLoc contained a disinfectant called alexidine that had never before been used in a contact-lens solution.

Other multipurpose solutions have very different molecules as disinfectants, which differ in size and chemical properties. Research has suggested these may have different levels of efficacy and also different effects on the surface of the eye.

Some potential risks are even less well understood. Several studies indicate that multipurpose solutions may harm the cornea itself -- most likely via the absorbing of disinfectant first into the contact lens and then into the eye. There, the disinfectant may cause corneal staining, the pattern of spots on the eye's surface that indicates where the cornea has been disrupted.

"Staining indicates a break in the integrity of the cornea," says Kenneth Lebow, an optometrist in Virginia who worked on Bausch's clinical trial for ReNu with MoistureLoc and has also done research sponsored by Alcon and Novartis AG's CIBA Vision Corp. "Once we have a break in the primary barrier of defense the potential increases for corneal infection."

According to the FDA, it is not unusual for contact-lens wearers to experience some low-grade corneal staining. And while there is no hard evidence that staining raises the risk of infection, studies show that some solution brands may cause higher levels of corneal staining than would be desirable.

The problem has been mostly linked to the latest generation of contact lenses, known as silicone-hydrogel lenses. The chemical properties of these lenses make them more prone to absorbing the disinfectants in certain brands of multipurpose solutions, experts believe. There is less concern about gas-permeable lenses, according to Dr. Epstein, because they don't interact as much with solutions, and past studies have shown significantly lower infection risk.

The most comprehensive study to address corneal staining, performed by Columbus, Ohio, optometrist Gary Andrasko, compares seven multipurpose solutions with five different types of lenses. In 5,000 separate tests on more than 400 contact-lens wearers, most subjects showed some minor levels of corneal staining.

But in Dr. Andrasko's continuing study, sponsored by Alcon, some combinations turned up worrisome results. One poor performer was AMO's solution. It produced higher levels of staining, especially when used with Bausch's PureVision contact lenses. AMO's Dr. Lasswell acknowledges that the study is correct, and says the company recommends to doctors that its solution not be used with that particular brand of lens.

Bausch's ReNu MultiPlus fared worse still. Even when used with the company's own PureVision lenses, it produced the highest levels of staining -- affecting an average of 73% of all subjects' corneal surface area.

Bausch says its own clinical trials showed that the two products, when used together, caused only minor levels of staining.

Two years ago, Christine Sindt, an assistant professor of clinical ophthalmology at the University of Iowa, informally tested three multipurpose contact-lens solutions on five volunteers in her office. She found that one solution -- ReNu with MoistureLoc -- produced "dramatic" corneal staining.

Dr. Sindt, who received no external funding for her study, immediately called Bausch. She says she told Fred Edmunds, then director of professional relations: "I think you guys have a problem."

Mr. Edmunds told her, she recalls, that what she had seen "wasn't a big deal." Mr. Edmunds couldn't be reached for comment. Bausch, which responded on behalf of its former employee, denies that Mr. Edmunds made the remarks. Bausch says that Dr. Sindt works closely with its contact-lens competitors, but acknowledged that she is working on a presentation for Bausch as well.

Information Links

• Lens solution the culprit in worldwide contact lens scare
• Update - Fusarium Keratitis --- United States, 2005--2006
• FDA Information
• News Update
• CDC Information
• General Information about Fusarium Keratitis
CDC confirms more cases of rare eye infection
• Rare eye infection puts new focus on contact-lens care