To: Softechie who wrote (2951 ) 8/4/1999 4:14:00 PM From: BARRY ALLEN Respond to of 4140
Bausch & Lomb Responds to Questions About Regulatory Status of Technolas 217 laser ROCHESTER, NY, Aug 4, 1999 (BUSINESS WIRE via COMTEX) -- - Pre-market application has been accepted for filing by the FDA - Company is awaiting determination as to whether or not panel review will be required - Next panel meetings are in September and November; agendas have not been finalized and published In response to heavy trading in its stock, apparently triggered by questions about the regulatory status of its Technolas 217 laser, Bausch & Lomb (NYSE/BOL) said today that it is still awaiting word on whether or not the FDA will require the company's pre-market application for approval of the laser to be reviewed by the agency's Ophthalmic Devices Panel. Panel meetings are scheduled for September 23-24 and November 18-19, and agendas for the meetings willbe finalized and published 15 days prior to each meeting. Bausch & Lomb's application was filed on May 28, 1999 and accepted by the agency in mid-July, indicating that the clinical data and information submitted by Bausch & Lomb were sufficient to permit the agency to conduct a substantive review of the application. The company said they expect to know within the next few weeks whether or not the application will require review by the panel. Bausch & Lomb is seeking FDA approval to market the Technolas 217 in the United States for use by ophthalmic surgeons in performing LASIK, the fastest growing refractive procedure for vision correction. The world's most technologically advanced excimer laser, the Technolas 217 leads the market in laser placements outside the United States. "Our plans anticipate the introduction of the Technolas 217 into the U.S. market by the end of this year," said Hakan S. Edstrom, senior vice president and president-pharmaceuticals/surgical for Bausch & Lomb. "A decision by the FDA to waive panel review of our application could accelerate that schedule by a month or two. However, if panel review is required, we believe our previously established introduction plan can still be met."