ReNu Moisture Loc solution adds FDA labeling

March 15, 2006

Rochester, NY?The FDA has cleared additional labeling claims for Bausch & Lomb's ReNu with MoistureLoc Multi-Purpose Solution (MPS). The FDA cleared labeling that includes a specific indication for ReNu with MoistureLoc solution use with silicone hydrogel contact lenses, and an additional claim that the product conditions contact lenses, in support of its original "sustained comfort" labeling claim.

Rochester, NY-The FDA has cleared additional labeling claims for Bausch & Lomb's ReNu with MoistureLoc Multi-Purpose Solution (MPS). The FDA cleared labeling that includes a specific indication for ReNu with MoistureLoc solution use with silicone hydrogel contact lenses, and an additional claim that the product conditions contact lenses, in support of its original "sustained comfort" labeling claim.

"While ReNu with MoistureLoc solution has always been approved for use with soft contact lenses, including silicone hydrogel lenses, Bausch & Lomb, in recognizing the accelerating growth of silicone hydrogel lenses, pursued the specific labeling claim to clarify and underscore further the appropriate uses of the product," said Gerard Warner, director, Lens Care Marketing, Bausch & Lomb.

Clinical data submitted to the FDA supporting the claim included a clinical evaluation of ReNu with MoistureLoc MPS when used with a variety of silicone hydrogel lenses. Seventeen practitioners in the United States monitored 400 patients in a cross-over study comparing clinical outcomes between ReNu with MoistureLoc solution and a competitive lens care regimen when used in combination with Bausch & Lomb PureVision silicone hydrogel lenses, and silicone hydrogel lenses from CIBA Vision and Vistakon.

"As our clinical data show, ReNu with MoistureLoc solution is compatible, safe, and effective with silicone hydrogel contact lenses. In fact, our most recent silicone hydrogel clinical data demonstrate that ReNu with MoistureLoc solution has superior overall comfort, end-of-day comfort, and comfort upon insertion compared with Opti-Free Express," said Jeffrey Nardoci, vice president, Marketing, Bausch & Lomb U.S. Vision Care.