Corneal staining chart at center of Bausch & Lomb, Alcon lawsuit

Key Points

Rochester, NY-Bausch & Lomb is suing Alcon Laboratories Inc. over what it calls a "false and misleading" system of rating corneal stains that it says unfairly attacks the credibility of its multipurpose contact lens solution (ReNu MultiPlus).

The civil lawsuit, filed June 26 in the U.S. District Court for the Western District of New York, said that the rating system constitutes false and misleading advertising. The suit seeks unspecified damages for lost sales and corrective advertising.

The rating system targeted in the lawsuit is a chart developed by Gary Andrasko, OD, a Columbus, OH, optometrist, and used by Alcon to indicate "safe" combinations of solutions and contact lenses. Dr. Andrasko based the chart, which can be viewed at http://www.staininggrid.com/, on ongoing studies pairing various brands of contact lenses and multipurpose solutions. According to the chart's color-coding system, green combinations are safe, yellow combinations warrant caution, and red combinations are unsafe and should be avoided. Dr. Andrasko's research was supported by an Alcon-funded grant.

"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, in the press release. "Alcon is extensively reporting conclusions not supported by the research, thus intentionally misleading, confusing, and deceiving the eye-care community and consumers."

The chart is based on "internationally recognized studies" and has been used for more than 1 year to inform physicians about corneal staining data associated with certain combinations of contact lenses and lens-care solutions, according to Kathleen Golden, strategic corporate communications, Alcon.

"There is nothing false or misleading about the well-documented corneal staining data incorporated in some of these materials," Golden said in a prepared statement.

The chart shows that Bausch & Lomb's multipurpose contact lens solution caused stains to 73% of corneas 2 hours after the solution was combined with Bausch's hydrogel (SofLens 66) and silicone hydrogel (PureVision) lenses. Staining levels with both lenses were considered "excessive," and 93% and 100% of patients tested were listed in the red "biocompatibility zone," indicating an unsafe combination. Percentages were lower with other types of lenses, including two that registered stains in 1% (Acuvue hydrogel lens, Vistakon) and 4% (Biofinity silicone hydrogel lens, CooperVision) of corneas.

In its press release, Bausch & Lomb said that Alcon simplified the corneal staining diagnostic process by focusing on the subjective estimate of area when evaluating the ocular surface and ignoring the critical attributes of type and depth.

Low-level staining

The company also noted that eight of 10 patients who do not wear contact lenses exhibit low-level corneal staining, and that low-level corneal staining-which often is transient and asymptomatic-commonly is observed in successful contact lens wearers.

"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," Moore continued. "The medical industry has always demanded clinically relevant data, not promotional claims posing as science, and Alcon must be held to that same standard."

In April, Goldman Sachs analyst Lawrence Keusch expressed concern about the effect the staining grid might have on Bausch & Lomb's stock price. According to an April 2 article on http://www.forbes.com/, after Dr. Andrasko presented him with the results of his ongoing studies, Keusch suggested in a client note that physicians might use this material to steer patients to solutions that are more compatible and cause less staining.

"While we are making no changes to our neutral rating on Bausch & Lomb shares, we believe that any increasing focus on corneal staining and solutions biocompatibility could represent another obstacle facing the company as management attempts to rebuild ReNu market share," Keusch wrote.