special report
Answering
to The Market
Hard questions on Fusarium and MoistureLoc
and responses from professionals in the know.
Joseph
T. Barr, OD, MS, FAAO: More than 1,800 optometrists were invited to attend this
roundtable. Many of them have submitted questions that we will address today.
Q: Why did it take so much time to
recall MoistureLoc, and why did you not recall the product completely when you withdrew
it from Singapore and Hong Kong?
A: Angela Panzarella:
About 3 months
passed between the time we were informed of an increase in fungal cases in Asia
in February and when we withdrew the product worldwide on May 15, 2006. Along the
way, we worked as quickly as possible, guided by science, regulatory agencies, and
our desire to do what we deemed necessary to protect the safety of patients.
Q: Once you recalled MoistureLoc, why
did it take so long to get sufficient stocks of your other product, MultiPlus?
A: Angela Panzarella:
Patient safety
was our first priority. We immediately switched our manufacturing facilities over
to producing more ReNu MultiPlus and the original ReNu Multi-Purpose solution, but
it required some time to produce sufficient quantities.
Q: Are there other fungi or bacteria
that are likely to attach more readily to the polymers in MoistureLoc?
A: Praveen Tyle, PhD: We have no evidence
that Fusarium, or any other fungus or bacterium, attaches to these polymers more
than to any other polymer.
Q: Do you think the combination of
silicone hydrogel lenses and all-in-one solutions caused the infections?
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Gary
Orsborn, OD |
A: Gary Orsborn, OD: There is no clinical,
scientific or anecdotal evidence to support that theory.
Q: How can I recommend MultiPlus
to my silicone hydrogel patients when scientific reports associate the solution
with corneal staining?
A: Christopher Snyder, OD: I see some
staining, I grade it, I note it, and I don't see that as being a bigger issue
with MultiPlus than with other lens care products, based on my clinical experience.
I've been looking for it because of these reports. I just can't seem to validate
the reports.
Q: How much did this controversy
cost Bausch & Lomb?
A: Angela Panzarella:
We spent millions
of dollars on the investigation, and we had hundreds of people working on it nonstop.
Sales of ReNu with MoistureLoc last year were about $100 million. We certainly expect
to offset a great deal of those lost sales with our other ReNu products. As we have
told Wall Street, Bausch & Lomb has a very strong balance sheet, and we're going
to invest what we need to invest to regain our brand equity and to develop new products.
We're committed to continuing to be the leader in the lens care category.
Q: What will happen with the ReNu brand?
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Christopher Snyder, OD |
A: Angela Panzarella: The ReNu brand
has terrific brand equity with consumers around the world, and we're committed to
continuing to invest and support that brand. But we don't think we should simply
return to business as usual. We know how important it is to let consumers and practitioners
know they can be completely confident about the safety and efficacy of ReNu MultiPlus.
And we are working to reinforce with consumers and practitioners the importance
of good lens wear and care practices.
Q: When will Bausch & Lomb launch
a new solution?
A: Angela Panzarella: Ideally, we intend
to launch a new solution within the next 18 to 24 months as we continue to invest
in product development. We have no plans to reintroduce the same MoistureLoc formulation,
but we have learned an incredible amount that will help us in the development of
new lens care products.
Q: Has news of the Fusarium and MoistureLoc issue led to noticeable increases in contact lens dropouts?
A: Jack Schaeffer, OD:
On the contrary,
I feel the contact lens market will grow. Doctors and patients are working together
again to use contact lenses and lens care products properly.
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Jack Schaeffer, OD
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A:
Dr. Snyder: We have seen increased awareness, prompting patients to come in for
check-ups. It's started a dialogue that has had positive effects.
Q: Should this situation encourage
the industry to return to a rub regimen of lens cleaning?
A: Dr. Schaeffer: I think most doctors
have already returned to a rub regimen, especially with the advent of silicone hydrogel
contact lenses, which attract lipid deposits.
A: Dr. Snyder: I've actually never
really left the rub regimen. I would appreciate labeling that supports this recommendation.
We know from studies of long ago that simply rubbing a lens removes 99.9+% of microbial bioburden, leaving very little for the solution to act on.
Contact Lens Spectrum, Issue: September 2006