B&L panel addresses questions about Fusarium investigation

LAS VEGAS – A panel of optometrists, industry representatives and scientists convened here Thursday at Optometry’s Meeting, the American Optometric Association (AOA) Congress, to discuss lessons learned from investigations of ReNu with MoistureLoc solution and its possible link to a recent outbreak of Fusarium keratitis in Singapore, Hong Kong and the United States. The solution was recalled from worldwide markets on May 15.

The panel consisted of Jack Schaeffer, OD, incoming president of the AOA’s Contact Lens and Cornea Section; Gary Orsborn, OD, of Bausch & Lomb; Praveen Tyle, PhD, vice president and chief scientific officer of Bausch & Lomb; Angela Panzarella, vice president of Global Vision Care, Bausch & Lomb; and Chris Snyder, OD, MS, FAAO, professor of optometry, University of Alabama at Birmingham. The discussion was moderated by Joseph T. Barr, OD.

The panelists addressed several pre-submitted questions from news outlets, regarding the scientific causes of the Fusarium outbreak, the company’s decision to recall ReNu with MoistureLoc and the impact of this situation on the future of lens care.

The decision to recall

One question, directed to Ms. Panzarella, raised the issue of why, upon hearing of the first clusters of Fusarium in Hong Kong and Singapore, Bausch & Lomb did not recall the product immediately around the world.

“I think in a recall situation, decisions get critiqued with 20/20 hindsight,” Ms. Panzarella said. “We were dealing with the information we had at the time. There were no unusual trends anyplace else. Based on the information we had, it appeared to be a local situation.”

Another question asked why, once ReNu with MoistureLoc was recalled, it took such a long time to get sufficient stocks of other products, such as ReNu MultiPlus, on the shelves as substitute solutions.

“We had to act quickly, regardless of whether we had substitute stocks,” Ms. Panzarella said. “We were aware that this might disrupt and inconvenience patients, but we were more concerned about safety issues.”

The noncompliance factor

In a question directed to Dr. Orsborn, one interviewer asked why, if the outbreaks were related to noncompliance issues, this should become a problem so suddenly. The questioner added that noncompliance has been an issue for quite some time.

“We haven’t said that noncompliance is the reason for this,” Dr. Orsborn said. “This is a multifactorial problem dealing with a rare infection. Some aspects of noncompliance in the use of this formulation, related to evaporation or ‘topping off,’ may have contributed. Noncompliance is a factor among many factors.”

Drs. Schaeffer and Snyder were asked whether the industry should return to a rub regimen for contact lens solutions. “Absolutely,” Dr. Schaeffer said. “I think we already have, especially with silicone hydrogels.”

Dr. Snyder agreed. “I never really stopped. Rub and rinse is a good option,” he said. “The industry is starting to recognize that. You’ll notice on bottles of solution that the words ‘no rub’ are getting smaller and smaller.”

When asked whether eye care practitioners have become lax in enforcing compliance, Dr. Schaeffer was emphatic. “We haven’t become lax, we are lax,” he said. “This has turned into a wake-up call. We’re now taking control, telling patients that they need to take care of their lenses.”

Ms. Panzarella was asked what will happen to optometrists who are sued for having recommended ReNu with MoistureLoc. “It is our thought that this will be rare,” she said. “If all the doctor did is recommend the solution, they usually don’t have liability. The third-party manufacturer would have liability. But it is an individual-case situation.”

Questions about ReNu MultiPlus

Concerns were also raised about ReNu MultiPlus. One question addressed to Dr. Orsborn pertained to whether ReNu MultiPlus is compatible with silicone hydrogels. “We have in vitro and clinical evidence that ReNu MultiPlus is compatible with silicone hydrogels,” he said.

Another questioner asked how doctors can suggest that ReNu MultiPlus is compatible with silicone hydrogels when there has been evidence of corneal staining with this solution. “I put that in context with other signs and symptoms,” Dr. Orsborn said. “I have a happy patient and a normal-looking cornea. If there is some staining, I see it. I grade it. There is no difference in this between ReNu and other solutions.”

The future

Ms. Panzarella was asked how much this situation has cost Bausch & Lomb. “The investigation alone cost millions of dollars,” she said. “We’ve had hundreds of scientists focusing on this. Our goal is to recover a lot of it through our other lens care products.”

One question posed to Dr. Schaeffer asked whether the Fusarium issue will result in a marketplace drop in the use of contact lenses.

“To the contrary,” he said. “Every crisis is opportunity. We are taking better care of patients. Patients have expressed increased interest in their lenses. They have a better appreciation of the fact that contact lenses, if cared for properly, are safe. It has started a dialogue.”