Detailed information on risks associated with Bausch & Lomb's Zyoptix wavefront ablation system will be available in print and web forms as a supplement to TV broadcast advertising for the product.

Risk information will be accessible on B&L's website in accordance with recommendations in FDA's Feb. 10 draft guidance on consumer-directed broadcast device advertising (¹ Also see "Device DTC Guidances Aim To Hone Enforcement, Stimulate Patient Education" - Medtech Insight, 9 February, 2004., p. 6).

The Zyoptix TV ad will direct consumers to a detailed print ad in an upcoming issue of Prevention magazine and include toll-free access that connects to a physician referral operator. FDA's guidance stipulates that firms offer "a mechanism to provide package labeling to consumers with restricted access to sophisticated technology, such as the Internet."

Access can be provided "in the form of print advertise-ments appearing concurrently in publications that reach the exposed audience," FDA suggests.

At the Food & Drug Law Institute's Conference on Advanced Medical Device Issues Feb. 12-13 in Washington, D.C., Office of Device Evaluation Deputy Director Philip Phillips solicited industry comments on the guidance, due May 10. The draft draws on a 1999 DTC drug document, but further elaboration on risks associated with devices may require distinct attention, he suggested.

The Zyoptix campaign, launched the week of Feb. 9, marks the first manufacturer-sponsored TV advertisement for laser eye treatment, B&L says. The ad will air through the February Sweeps, the first high- ratings period since the product's October approval.

B&L hopes its brand recognition will spur customer interest. In the commercial, a man describes his wife's decision to choose Zyoptix: "She was ready for laser surgery, but didn't know who she could trust." The commercial targets a wide demographic, airing during national morning and evening news programs, as well as a range of prime-time shows, from "The Bachelorette" to ESPN's "Sportscenter."

Competitors Visx and Alcon have no plans for DTC TV advertising of their respective LASIK products, Customvue and LADARvision , but VISX provides support to physician advertising efforts.

Last year, Ciba Vision received a July FDA letter relating to its TV ads for Focus Night & Day contact lenses (² [A#01290350002], p. 4).

B&L Focuses On Brand Recognition For Zyoptix DTC Campaign

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