Bausch & Lomb Provides Additional Information to FDA in Response to Warning Letter Regarding Advertising and Promotion for PureVision-tm-.

ROCHESTER, N.Y.--(BUSINESS WIRE)--May 3, 1999--

-- Company modifies promotional materials pending further

FDA review

-- Availability and sale of PureVision extended wear lenses

are not compromised

Bausch & Lomb (NYSE:BOL), the leading global technology-based healthcare company for the eye, today acknowledged receipt of a "warning letter" from the U.S. Food and Drug Administration, regarding advertising and promotion for PureVision(tm) soft contact lenses.

"We take this matter seriously and are giving the FDA's concerns our immediate and full attention in order to address the issues raised," said Bausch & Lomb President and Chief Operating Officer Carl Sassano. "We have exercised prudence and ceased distribution of materials containing the claims questioned by the FDA pending further discussions with the agency.

"It is important to understand that the FDA's objections relate to our advertising and promotional materials; there are no issues with the safety and efficacy of this product," Sassano continued. "The issues raised by the FDA 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, which have been enthusiastically received by both doctors and their patients."

In the letter dated April 23, 1999, the FDA objects to certain claims in advertising and promotional literature about PureVision lenses, which include the following:

-- That PureVision lenses provide "a new level of ocular health"

-- That the lenses are for "continuous wear" and may therefore be considered different from the "extended wear" category of which they are a part

-- That "continuous wear" lenses are superior to "extended wear" lenses because of their design

According to the FDA, data submitted by Bausch & Lomb in pursuit of the agency's approval of PureVision lenses does not enable the agency to validate and allow these promotional claims to be made, either implied or expressed. Therefore the agency has directed Bausch & Lomb to stop making the claims; and has requested supplemental information supporting the claims. The company has submitted a detailed response to the warning letter, and has expressed its strong desire to meet immediately with the FDA to address the agency's concerns.

Bausch & Lomb will continue to promote the unique attributes of the PureVision lens. New promotional materials, supported by clinical data previously provided to the FDA, have been developed emphasizing the product's high oxygen transmissibility, which, among other things, allows for low levels of overnight corneal swelling. The materials will also highlight the performance of the lens, including excellent comfort, visual acuity, and movement, along with easy handling.

PureVision contact lenses are approved by the FDA for 7-day extended wear. They are made of balafilcon A, with revolutionary AerGel(tm) technology for excellent oxygen transmissibility, and the Performa(tm) surfacing technology that creates a consistent wettable surface for optimal visual acuity and comfort.

PureVision lenses were launched nationwide in the U.S. last month.

Bausch & Lomb Incorporated is the global technology-based healthcare company for the eye, dedicated to helping consumers see, look and feel better through innovative technology and design. Its core businesses include soft and rigid gas permeable contact lenses, lens-care products, ophthalmic surgical and pharmaceutical products. The company is advantaged with some of the most respected brands in the world starting with its name, Bausch & Lomb(R), and including SofLens66(tm), Boston(R), ReNu(R), and Storz(R). Founded in 1853 in Rochester, N.Y., where it continues to have its headquarters, the company has annual revenues of more than $2 billion and employs approximately 15,000 people in 35 countries. Bausch & Lomb products are available in more than 100 countries around the world.