A Medical Device Daily

Eye care firm Advanced Medical Optics (AMO; Santa Ana, California) last week reported that the FDA has recommended that the company enroll additional subjects in its U.S. clinical study for the Tecnis Multifocal intraocular lens (IOL).

The trial was originally to have included 300 patients from the U.S. and Europe.

AMO did not disclose the number of patients to be added or the issues raised by the agency.

AMO said it still intends to file a premarket approval (PMA) application for the Tecnis Multifocal IOL next month, in accordance with its original plan to launch the product in the U.S. in the first half of 2008.

However, it said that in light of the latest questions raised by the FDA, the company now believes there is “reasonable likelihood” that the launch timeline could be extended by 12-18 months, thus into 2009 or even early 2010.

The company said it believes that the data from the trial are “compelling and unrelated to the FDA’s questions,” which have to do with “sample size assumptions from the protocol established in the investigational trial exemption (IDE) before [the] U.S. trial commenced in late 2004.”

Lawrence Biegelsen, device analyst with Prudential Equity Group (New York) in a report wrote that the delay is likely to benefit Alcon, which is poised to launch a competing product, its ReSTOR IQ IOL in early ’07. “We believe a delay to the Tecnis MF and the ’07 launch of the ReSTOR IQ will significantly reduce the positive buzz surrounding the Tecnix MF lens,” Biegelsen wrote.

AMO acquired the Tecnis IOL technology via the purchase of Quest Vision Technologies (Tiburon, California) in 2005 for an undisclosed sum (Medical Device Daily, May 5, 2005). Tecnis technology features a “shape-changing” optic system that adjusts to the changing musculature of the eye.