ROCHESTER, N.Y. — Bausch & Lomb (NYSE:BOL) has filed a civil suit against Alcon Laboratories, Inc. (NYSE:ACL), seeking to stop a broad-based advertising campaign of false and misleading claims about ReNu MultiPlus^® multi-purpose contact lens solution and other contact lens care solutions. The suit also seeks damages for the loss of sales based on Alcon’s deceitful claims, as well as corrective advertising. It was filed today in the United States District Court for the Western District of New York. 

At the center of the complaint is Alcon’s widespread use of a red/yellow/green color-coding chart to report the results of corneal staining tests run with various brands of contact lenses and multi-purpose solutions. With this chart, Alcon communicates that green solution-lens combinations are safe, yellow combinations warrant caution, and red combinations are unsafe and should be avoided. 

Contrary to Alcon’s repeated messages to doctors and consumers concerning the yellow- and red-designated combinations, scientific studies and clinical evidence to date have classified such staining as superficial punctate, which is considered to be clinically insignificant. 

The chart, which is used widely in Alcon advertising and promotional activities, was created by Dr. Gary Andrasko, an optometrist in private practice in Columbus, Ohio, whose research has been supported by a grant from Alcon Research Ltd.  

“The color-coding of corneal staining levels is wholly arbitrary and without clinical relevance. It intentionally exaggerates clinically-insignificant differences,” said Robert Moore, vice president and general manager of Bausch & Lomb’s U.S. vision care and OTC eye care business. “Alcon is extensively reporting conclusions not supported by the research, thus intentionally misleading, confusing and deceiving the eye care community and consumers.” 

“Alcon’s progressive encroachment and disingenuous actions are not only damaging the Bausch & Lomb brand, but also causing harm to the broader eye care marketplace. The medical industry has always demanded clinically-relevant data, not promotional claims posing as science, and Alcon must be held to that same standard.” 

Corneal staining describes the diagnostic process by which a medical practitioner applies a sodium fluorescein dye to the surface of a patient’s eye to evaluate the ocular surface in contact lens wearers and non-wearers alike. A proper evaluation measures area, type and depth; by contrast, Alcon uses a simplistic one-dimensional approach that considers only a subjective estimate of area, while ignoring the critical attributes of type and depth.

Almost 8 of 10 normal, non-contact lens wearing patients exhibit low-level corneal staining, and low-level corneal staining is commonly observed in successful contact lens wearers. In the vast majority of cases, such corneal staining is transient in nature and asymptomatic. Alcon’s own research confirms that the staining identified in its promotional chart is both transient and asymptomatic. However, the chart is being used improperly to attack the safety of ReNu MultiPlus, a product that has been used successfully by millions of consumers for the last ten years, and which is the number one selling formulation in the U.S.