Court: J&J, Ocular Insight settle over contact lens ad claims

Jacksonville, FL and New York

-In response to a complaint filed in July by Johnson & Johnson (J&J) Vision Care Inc., a U.S. district court in New York has ordered Ocular Insight Inc. to discontinue permanently stating or communicating in its advertising, promotional materials, or activities for the company's contact lenses (Clear 58) in the United States any of the following claims:

• Clear 58 is approved by the FDA.

• Clear 58 is approved by the FDA as a generic equivalent lens to ACUVUE 2 brand contact lenses.

• Clear 58 is a generic equivalent to ACUVUE 2.

• Clear 58 is an exact duplicate or is identical to ACUVUE 2.

"In the interest of patient safety, we felt an urgent need to address these misleading claims as quickly as possible," said Naomi Kelman, president, Americas, Vistakon, Division of Johnson & Johnson Vision Care Inc. "While [the contact lens] has been 'cleared' for marketing by the FDA, it has not been 'approved' by the agency. Furthermore, the FDA does not perform the function of assessing whether a contact lens may be prescribed as a 'generic equivalent' lens."

On behalf of Ocular Insight, Mark Levin, the company's president, said, "Experience has led us to allow eye-care practitioners to determine if a contact lens made of the same material, same water content, same base curve, same diameter, and same method of manufacturing is a viable product to substitute for a branded product they currently dispense."