Bausch & Lomb Pharmaceuticals is Working Closely With the FDA to Resolve Concerns Expressed in Its Warning Letter.

ROCHESTER, N.Y.--(BUSINESS WIRE)--Nov. 3, 1998--

- Issues have no material impact on company's financial results

- Product line in question generates less than $1 million in sales

In response to news reporter inquiries, Bausch & Lomb (NYSE:BOL), acknowledged receipt of a "warning letter" from the U.S. Food and Drug Administration. The letter was sent to its subsidiary, Bausch & Lomb Pharmaceuticals Inc.

Bausch & Lomb has given its immediate and full attention to the agency's letter dated October 1, concerning the storage conditions of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (sterile), a generic ophthalmic eye drop product, and its general procedure for the evaluation of test results.

We have been working closely with the FDA over the past month to thoroughly answer all questions and resolve the issues the agency has raised. Based on our face-to-face discussions, we have proposed a testing protocol to address the agency's concerns regarding the product storage conditions. We have also proposed modifications to our general evaluation procedure and have received indications from the FDA that the modifications are acceptable.

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP (sterile), is an ophthalmic antibiotic steroid. Sales of the product are less than $1 million.

Bausch & Lomb Pharmaceuticals, Inc. is a subsidiary of Bausch & Lomb Incorporated, the world's leading eye-care company. With its headquarters in Tampa, Florida, Bausch & Lomb Pharmaceuticals has been manufacturing and marketing ophthalmic pharmaceutical products since 1986. The company produces both generic and branded, prescription and over-the-counter medications.