This article is more than 5 years old. Information may no longer be current.
FDA issues warning letter regarding new PureVision contact lenses
Click Here to Manage Email Alerts
ROCKVILLE, Md. — The introduction of a new contact lens that can be worn up to 7 days continuously remains a difficult one as the Food and Drug Administration (FDA) issued a warning letter to Bausch & Lomb Inc. regarding claims made in its marketing material.
In an April 23 letter from Lillian Gill, director of the Office of Compliance of the Center for Devices and Radiological Health, to Bausch & Lomb chairman and chief executive officer William M. Carpenter, the FDA charges that the company’s promotional materials have “misbranded and adulterated the company’s PureVision lenses.” The letter does not raise objections to the safety or efficacy of the PureVision lenses.
Bausch & Lomb has taken steps to comply with the FDA’s letter, according to president and chief operating officer Carl Sassano. “We take this matter seriously and are giving the FDA’s concerns our immediate and full attention in order to address the issues raised,” Mr. Sassano said in a statement issued by Bausch & Lomb. “We have exercised prudence and ceased distribution of materials containing the claims questioned by the FDA pending further discussions with the agency.”
Claims not supported in PMA
Through its promotional materials, Bausch & Lomb has implied a superiority of its “continuous wear lens” over extended wear lenses, according to the FDA. The FDA also reacted to the claim that the PureVision lens achieves a “new level of ocular health.” This statement is apparently based on data comparing overnight corneal swelling in PureVision wearers to patients not wearing any type of lens, the agency said. The FDA said referring to this data was acceptable, but objected to Bausch & Lomb’s conclusion that the reduced swelling results in a ‘new level of ocular health’, because the company has “not submitted data to support the conclusion.”
A promotional brochure also claims “a significantly lower level of hypoxia-related effects compared to a conventional [extended wear] hydrogel lens” and refers to a 4-month clinical investigation. The data sets submitted in Bausch & Lomb’s Premarket Approval Application (PMA) involved studies of 6 months and 12 months. The PMA also did not include data to support the company’s claim that a “high percentage of bound water results in minimum dehydration,” according to the FDA.
The FDA’s objections will have “no material impact on the company’s financial results and we do not believe they will compromise the availability and sale of PureVision contact lenses,” according to Mr. Sassano.
Continuing controversy
The FDA’s action is the latest controversy surrounding efforts to market a lens for continuous wear, with Bausch & Lomb and CIBA Vision both developing lenses intended to be worn for up to 30 days without removal or cleaning.
On March 19, Vistakon, a Johnson & Johnson company, filed a lawsuit objecting to “false and misleading” statements in Bausch & Lomb’s marketing materials. Johnson & Johnson claims that the FDA’s warning letter raises the same issues the company did in its lawsuit. “Johnson & Johnson intends to continue its lawsuit seeking corrective advertising, a permanent injunction and damages,” said the company in a statement issued after the FDA’s action.
For Your Information:
- Lillian Gill can be contacted at the Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850.
- Carl Sassano, president and chief operating officer of Bausch & Lomb, can be contacted at 1400 N. Goodman St., P.O. Box 450, Rochester, NY 14692; (716) 338-6000; fax: (716) 338-6481.
- Vistakon can be contacted at P.O. Box 10157, Jacksonville, FL 32247; (904) 443-1000.
- Warning letters issued by the Food and Drug Administration can be viewed on the agency’s web site at www.fda.gov/foi/warning.htm.