Fusarium cases might cause change in product-testing procedures

As Bausch & Lomb developed its ReNu with MoistureLoc solution, it tested its biocidal efficacy, how well it tackled various fungi and other ocular pathogens. It studied how long the solution remained stable and sterile. It performed tests to discover how the solution locked in moisture with its Poloxamer 407 and Polyquaternium 10, two polymers that worked together to inhibit deposits and create what the company called a "cushion of moisture" for greater comfort on the eye.

It worked to determine the best methods for using the product, all carefully spelled out in patient advisory leaflets.

Despite all these pre-market tests, the company apparently did not anticipate fully how patients might misuse the product and fail to comply with recommendations. Because patients did not follow recommended methods, the company now says, patients unwittingly allowed the potency of the solution to change as the liquid evaporated from their cases and they simply "topped off," adding fresh solution to the old. The situation led to more than 130 reports of Fusarium keratitis in the United States and more worldwide, and 37 of these patients required corneal transplants, according to the U.S. Centers for Disease Control and Prevention (CDC).

After what Bausch & Lomb describes as "exhaustive" new tests performed since the cases started emerging this winter, the answer is-not surprisingly-no. And that apparently led to the demise of a $100 million product and at least $50 million to $70 million in costs associated with its recall.

Penny A. Asbell, MD, FACS, MBA, says this incident might give companies something more to consider in the way they test their products before bringing them to market. She suggested that companies reproduce how patients might actually use a product other than the way it is intended.

"Maybe we've discovered some things that should be evaluated during the FDA approval process," said Dr. Asbell, professor of ophthalmology at Mt. Sinai School of Medicine, New York, and a past-president of Contact Lens Association of Ophthalmologists (CLAO). "It may be it's appropriate to develop such methodology for future testing. I think it's an area that needs to be explored."

Even if the FDA does not require such testing, she said, companies might discover new problems with their products.

"To some extent, this unfortunate problem has brought to light a new way of testing products," Dr. Asbell said. "I wouldn't be surprised if a new methodology isn't developed."

FDA spokeswoman Kristen E. Neese said a group has been formed to evaluate the international lens care product testing standards, including a "hazard analysis" concept within design controls in the quality system regulation.

"The Fusarium event demonstrated what may happen with misuse, such as 'topping off' old solution in the lens case and not using fresh solution each day," Neese said. "However, the fundamental product testing has always been based on the labeled directions for use."

Bausch & Lomb's chief medical officer, Brian Levy, OD, said patient compliance has always been a risk factor for the company. But the whole experience with ReNu with MoistureLoc has revealed the need for additional testing, Dr. Levy said.

"As a lesson from this experience, we will be formulating and testing our future products very differently. We will be taking the lessons learned into our future testing," said Dr. Levy, who declined to elaborate.

However, Harry Zink, MD, president of the American Academy of Ophthalmology, questioned whether a company could reproduce those situations before bringing a product to market.

"It's an interesting question," Dr. Zink said. "The universe of noncompliance is pretty broad."