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ReNu with MoistureLoc Contact Lens Solution Fungus Final Report

Contamination not the cause, however MoistureLoc formula with poor compliance may have contributed to fungus infections.


 

In a letter distributed to eye care professionals, Bausch & Lomb provides details of the final findings of investigation into the recent outbreak of Fusarium keratitis.

Dear Eye Care Practitioner:

I am very pleased to let you know that I have very recently joined Bausch & Lomb as Director of Professional Relations. This opportunity allows me to also continue my 25 year association with the University of Alabama at Birmingham, now as an adjunct Professor of Optometry, and to remain in active practice, continuing my history of 28 years as a clinician colleague.

While I have taken the liberty of starting this letter all about me, this communication is primarily intended to update you on the investigation into the cases of Fusarium keratitis associated with contact lens wear. In recent weeks I have had conversations with many of our peers and in the process it became clear to me that there may be some uncertainty as to the outcome of the Fusarium investigation within minds of the ECP community. With that in mind, I’ve included highlights below from a recent article regarding the investigation’s outcome as presented by the Centers for Disease Control (CDC) and Prevention in The Journal of the American Medical Association (JAMA).

The August 23, 2006 issue of JAMA contained an article drafted by a team from the CDC, which outlined the process and findings of an epidemiological investigation of Fusarium keratitis occurring among contact lens wearers in the United States. The article titled, “Multistate Outbreak of Fusarium Keratitis Associated With Use of a Contact Lens Solution” -- was the CDC’s final report on this matter and helped provide important information that would educate the healthcare community regarding this unusual medical event. Go to http://www.bausch.com/article to order your free copy of the article.

What is noteworthy in this article, as well as other research, is that the association between the Fusarium outbreak and contact lens solutions was limited to the MoistureLoc® formula. The U.S. Food and Drug Administration supported the same conclusion, as do data published in a separate “case-control” study by the Hong Kong Centre for Health Protection on June 10, 2006 (Communicable Diseases Watch, Volume 3, Number 12.). You and your patients can be assured of the safety and efficacy of Bausch & Lomb ReNu MultiPlus, which has a proven track record for more than nine years.

The following are some other key findings and observations from the final CDC article published in JAMA:

As of June 30, 2006, the CDC identified 164 confirmed cases of Fusarium keratitis in 33 states and one U.S. territory. Of these, 154 reported wearing soft contact lenses. A case-control study was conducted to delineate factors, which may have contributed to the disease. The investigation of the clinical events, including the infecting organism as well as the solution and manufacturing sites, led the CDC to conclude that contamination of the MoistureLoc product at the source was not a possible cause.

Results of extensive testing led Bausch & Lomb and the CDC to conclude that some aspect of the MoistureLoc formula, along with certain aspects of non-compliance, may increase the relative risk of rare Fusarium infections in unusual circumstances. The report states, “It appears that this outbreak may have been caused by a complex and, as yet, undetermined interaction between MoistureLoc, Fusarium, and possibly the lens case or contact lens.” The CDC study also found that patients with the infection were more likely than controls to store lenses by re-using solution already in their lens cases. They were also less likely than controls to never clean their lenses by rubbing.

The report’s conclusions, with which Bausch & Lomb agrees, are that clinicians should be vigilant in the diagnosis and treatment of fungal keratitis, and that users of MoistureLoc should discontinue use of the solution.

I understand that this issue may have caused confusion and concern among our patients, and that’s why I wanted you to be aware of these important findings. You can be confident that Bausch & Lomb will continue to work with eye care practitioners to encourage proper and effective lens care practices, as part of our ongoing commitment to the health and safety of our patients.

As always, we at Bausch & Lomb welcome your input.

Sincerely,

Chris Snyder, OD, MS

Director, Professional Relations - Bausch & Lomb Inc


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