BB&T Executive Editor

On April 25, the second day of a two-day meeting, the Ophthalmic Devices Panel of the FDA's Medical Devices Advisory Committee will discuss the "general issues concerning the post market experience with laser-assisted in situ keratomileusis" (Lasik). These issues are fairly well known, ranging from the visual side effects of glare and halos to, very rarely, loss of vision.

Rick Wise, device analyst with Bear Stearns, issued a note on the meeting, saying, "Aside from visual side effects after Lasik surgery, we expect the FDA review will include psychological setbacks (with an emphasis on depression)."

He said that those having the Lasik procedure normally sign consent forms "which illustrate a myriad of risk factors ... mainly limited to the patient's vision rather than potential emotional and quality of life issues."

He added that one possible fall-out from the hearing could be a requirement by the FDA that these consent forms include the possibility of "psychological" risk factors, such as depression.

"Since 1990, the industry has been addressing Lasik risk factors through improved technology and training," according to Wise's note, "and the meeting's impact will likely be a neutral for Advanced Medical Optics [Santa Ana, California] (34% of sales), Alcon [Huenenberg, Switzerland] (~1%), and Bausch & Lomb [Rochester, New York] (6%). We would be surprised if testimonials at the hearing resulted in a decrease in procedures" since he said patients are already well informed concerning the risks.

Wise reported that from 1996-2006, FDA has received about 150 patient complaints regarding Lasik. But he quoted industry statistics of up to 96% procedural satisfaction — defined as a person's likelihood to recommend the procedure to someone else.

The first day of the ophthalmic panel meeting will focus on considering a premarket application — previously given a panel vote recommending against approval — from Visioncare Ophthalmic Technologies (Saratoga, California) for its implantable miniature telescope (IMT). The IMT is a visual prosthetic comprised of a small telephoto lens that enlarges images and serves to reduce the blind spot resulting from macular degeneration and indicated for implant in patients with stable, moderate-to-profound central vision impairment due to bilateral central scotomas associated with end-stage macular degeneration and cataract.