Bausch & Lomb Issues Doctor Advisory
re: ReNu Contact Lens Solution Fungus Infection

April 13, 2006 (Rochester, NY)

Dear Doctor,

We want to ensure that you have the latest information about our ongoing efforts to investigate cases of fungal keratitis in parts of Asia and the U.S. At Bausch & Lomb, our highest priority is the health and safety of your patients. If you have comments, questions or suggestions following your review of this communication, please contact us as indicated below.

As you may have heard, reports of an unusual incidence of Fusarium keratitis among contact lens wearers first came from health authorities in Singapore, Hong Kong and Malaysia. Because these infections are rare, there is now a heightened level of awareness and surveillance in other countries, including the U.S. This is not an infection that has been tracked closely in the past, so the actual number of cases, and the deviation from "normal" background levels of infection, is unknown.

Shipments of ReNu with MoistureLoc are Temporarily Suspended in U.S.

The U.S. Centers for Disease Control and Prevention (CDC) have analyzed the Fusarium infections of 28 contact lens users, 26 of whom remembered what lens care product they used. Twenty-one reported using ReNu-brand products, and five reported using a combination of ReNu and products manufactured by other companies. There is an apparently disproportionate representation of ReNu® with MoistureLoc® in the CDC data, although both the CDC and the Food and Drug Administration (FDA) have emphasized that no causal relationship between ReNu with MoistureLoc and these incidences of fungal keratitis has been found. However, we at Bausch & Lomb intend to make every effort to assist with this investigation in order to quickly identify the root cause of these infections. To this end, we have voluntarily suspended shipment of ReNu with MoistureLoc here in the U.S., pending further investigation.

Bausch & Lombís FDA-licensed manufacturing facility in South Carolina has been extensively monitored. Bausch & Lomb does not manufacture any pharmaceutical or surgical products in this facility.

In addition, Bausch & Lomb does extensive, ongoing testing of its products and has conducted additional tests to ensure the biocidal efficacy of our lens care regimens against Fusarium and a host of other ocular pathogens. For example, product from the lots of ReNu with MoistureLoc multi-purpose solution that were identified as being used by patients in Singapore, Hong Kong and the U.S. were tested and shown to be effective in killing both standard strains and clinical isolates of the fungus. Product samples collected from these markets were tested against a full panel of biocidal challenge organisms, and chemical testing — including testing of component materials — has been performed. Again, these tests indicated that the samples were within specification and highly effective in killing bacteria and fungi. We are pleased to work with the FDA and the CDC to investigate this matter, and we are gratified that the FDA has publicly viewed our decision to suspend shipment as a responsible step, regardless of the lack of causal connection.

Multi-Center Surveillance Programs with CDC and Wilmer Eye Institute

As reported by the CDC, an ongoing investigation by CDC, state and local health departments, and the FDA is under way to determine whether this cluster represents an increase of Fusarium keratitis infections and to determine the association, if any, of these cases with any product. Epidemiologic and laboratory studies will help define specific activities, hygiene practices, or products that place persons at increased risk for Fusarium keratitis.

We feel we must continue to thoroughly investigate the root cause of reported cases of Fusarium infections. As such, we are working closely with health authorities in Asia, the CDC and the Wilmer Eye Institute at Johns Hopkins University to implement a multi-center surveillance program to evaluate the actual incidence of the infection and try to determine its root cause. Bausch & Lomb is also working with independent experts in microbiology to collect and culture clinical isolates of Fusarium from patient samples to identify the genetic make-up of the organisms, and to determine if they represent an uncommon variant of the fungus.

Finally, as clinicians, we would like to remind you of the further advice of the CDC:

Clinicians evaluating contact lens users with signs or symptoms of keratitis, such as unusual redness, eye pain, tearing, discharge, or sensitivity to light, should consider fungal keratitis. Clinicians should consider obtaining clinical specimens (e.g., corneal scrapings) for culture before initiating treatment.

We share your concern about this potential threat to eye health, and are doing all we can to help determine the cause and extent of infections caused by Fusarium. We will continue to keep you updated as more information becomes available. We welcome your input; you can reach us in the following ways:

E-mail: eyehealth@bausch.com
Phone: 1 (800) 828-9030 – Push #3
Mail: Bausch & Lomb, Inc.
1400 North Goodman Street
Attn: Eye Health Program
Rochester, NY 14609