Here's a link to a copy of the letter...
http://www.optifree.com/images/DocLetter041206.pdf
Alcon
6201 South Freeway
Fort Worth, TX 76134-2099
(817) 293-0450
(800) 451-3937
April 12, 2006
Dear Doctor,
I am responding to the recent increase in the United States and Asia of reported cases of
fungal keratitis, an eye infection caused by the Fusarium species, associated with contact
lens wear and the decision by Bausch & Lomb on April 10 to suspend shipments of
ReNu® MoistureLoc®1. At this time, it is our understanding that the Fusarium keratitis
reports are associated mainly with one brand of multi-purpose contact lens solution. I
would like to reassure you and your patients that Alcon’s OPTI-FREE® EXPRESS® and
OPTI-FREE® RepleniSH™ Multi-Purpose Disinfecting Solutions (MPDS) are safe and
effective for cleaning and disinfecting contact lenses.
Alcon has confirmed with the regulatory authorities in Hong Kong, Singapore and
Malaysia that none of the Fusarium keratitis cases there have been associated with the
use of either OPTI-FREE® EXPRESS® or OPTI-FREE® RepleniSH™ Multi-Purpose
Disinfecting Solutions (MPDS).
In the U.S., the Food and Drug Administration (FDA) and the Centers for Disease
Control and Prevention (CDC) are conducting an ongoing investigation into the rise of
Fusarium keratitis cases in the U.S. On April 10, the CDC released a report stating that
all 26 (100%) evaluated cases of Fusarium keratitis involved a ReNu brand product or a
generic brand version manufactured by Bausch & Lomb, with five of these cases also
reporting the use of other solutions in addition to ReNu, including solutions made by
Alcon and another company. There were no cases reported in which OPTI-FREE®
EXPRESS® or OPTI-FREE® RepleniSH™ MPDS were used as the only disinfecting
solution, and the CDC has not provided us with information about the products involved
or the patterns of usage in the cases of Fusarium keratitis involving multiple products.
For more details about the CDC investigation, visit the following link:
http://www.cdc.gov/mmwr/pdf/wk/mm55d410.pdf
OPTI-FREE® EXPRESS® and OPTI-FREE® RepleniSH™ MPDS both employ
POLYQUAD® and ALDOX® as the disinfection agents in the formulations. These
compounds form the basis of a unique disinfecting system that is totally different from
the disinfection systems used in the ReNu branded products and the generic products
2
manufactured by Bausch & Lomb. The POLYQUAD® system has been used in Alcon
MPDS products for over 20 years, and has consistently been shown to be highly effective
against the Fusarium species and other potential ocular pathogens.
To further ensure the disinfecting efficacy of the POLYQUAD® and ALDOX® system,
OPTI-FREE® EXPRESS® has been subjected to a series of tests to demonstrate
effectiveness under exaggerated, real world conditions. The results of these tests
demonstrated:
- Even when the solution and lens are subjected to elevated storage temperatures of
50°C, OPTI-FREE® EXPRESS® MPDS showed a high level of antimicrobial
activity2.
o 100% log reduction of Fusarium solani
- In the presence of a contact lens, OPTI-FREE® EXPRESS® MPDS maintained
high antimicrobial activity2.
o 100% of normal log reduction of Pseudomonas aeruginosa
o 88% of normal log reduction of Staphylococcus aureus
Of course, to ensure the efficacy of any contact lens solution, it is necessary to reinforce
to your patients that they strictly follow the directions for use of their solutions. We also
encourage you to advise your contact lens-wearing patients to notify you immediately if
they notice any eye-related discomfort or changes in their vision.
Alcon will continue to monitor the situation closely and will communicate new
information to the community as it becomes available.
Sincerely,
Ralph Stone, PhD
Vice President, Clinical Affairs
For further information, please contact Ralph Stone at 817-568-6114.
1 Registered trademark of another company
2 Ruth A. Rosenthal, et al, Extreme Testing of Contact Lens Disinfecting Products, Contact Lens Spectrum,
Jul 2002