DELAYED PRODUCT LAUNCH HAS IMPLICATIONS FOR AMO STOCK, ANALYST SAYS

The FDA has recommended Advanced Medical Optics (AMO) enroll additional subjects in its U.S. clinical study for the Tecnis Multifocal intraocular lens (IOL), setting back the scheduled entry of the device into the U.S. market.

"AMO still intends to file a premarket approval application for the Tecnis next month in accordance with its original plan to launch the product in the U.S. in the first half of 2008," the firm said Jan. 3. But AMO now believes there is "a reasonable likelihood the launch timeline could be extended by approximately 1218 months."

The Tecnis lens has already been approved and launched in Europe and other international markets, making eventual U.S. approval likely, Merrill Lynch Research analyst Lee Brown said in a Jan. 4 research note. Clinical data to date suggest that the device "may be the best performing multifocal IOL on the market," Brown said.

Merrill Lynch had expected the launch of the Tecnis lens to help AMO take market share from Alcon in 2008 and 2009, Brown said. "As such, the possible delay may put some pressure on AMO's stock price. However, we are standing pat on our sales and earnings estimates given the current lack of visibility tied to the voluntary recall of certain eye care product lots and the temporary shutdown of its Chinese manufacturing plant, which we feel are the more dominant factors driving the stock price at present."