Practice pulse

Company Seeks Premarket Approval for Implantable Miniature Telescope

■ VisionCare Ophthalmic Technologies, Inc., a Saratoga, Calif. company that develops, manufactures and markets visual prosthetic devices, has filed a Premarket Approval (PMA) application amendment for its implantable miniature telescope.

The implantable miniature telescope is designed as a permanent solution for moderate to profound vision loss resulting from advanced, end-stage forms of age-related macular degeneration (AMD) that have no current surgical or medical treatment options, according to a press release issued by the company.

VisionCare Ophthalmic Technologies, Inc. submitted a PMA last year, though the Food and Drug Administration (FDA) panel required additional information on how the implant sat in the eye. This information was garnered from a prospective, multicenter Phase II/III trial, which evaluated the safety and efficacy of the device in more than 200 people who had moderate to profound bilateral central vision impairment linked with end-stage AMD.

Reality TV Star in LASIK Documdrama
The Web site www.realityLASIK.com, from Advanced Medical Optics (AMO), features an online docudrama about generation-Y actress Kristin Cavallari's quest for 20/20 vision via Advanced CustomVue LASIK with the IntraLase Method. The online series, which was underwritten and produced by AMO, follows every LASIK move Ms. Cavallari makes over a month to educate other members of generation-Y about this LASIK procedure. In conjunction with the series, AMO has requested others submit their own video, audio or diary documenting their own experiences for a cash prize of $5,000 to be awarded to the best entry. AMO will select one winner each month until December 31, 2007.

The miniature prosthetic telescope is said to render central vision on the central and peripheral retina in patients with advanced, end-stage forms of AMD who can't benefit from current surgical or medical treatment options.

Implantation

Surgeons implant the miniature prosthetic telescope, which is 4mm long and contains two wide-angle glass microlenses, in one eye during an outpatient procedure.

The device, together with the cornea, acts as a telephoto system to enlarge images 3x or 2.2x, depending on the model the surgeon implants.

This telephoto effect enables the patient to focus images in the central visual field over other healthy areas of the central and peripheral retina and not the damaged macula, generally helping to decrease the "blind spot" that impairs vision and hopefully improving the patient's ability to recognize objects that were hard or impossible to see, VisionCare Ophthalmic Technologies says.

Meanwhile, the non-implanted eye gives the patient peripheral vision for mobility and orientation.

Post-op

Post-op, the patient participates in a vision rehabilitation program so he can maximize his ability to perform daily activities using his new visual status. The program includes a multidisciplinary team incorporating expertise of practicing low-vision O.D.s and occupational therapists, the company says.

So, when will this device be available on the U.S. market?

"The technology is currently under regulatory review for marketing approval, so we don't know the actual pin-point month or date, but we hope it will be approved the second half of this year for patients with end-stage AMD," says Chet Kumar, director of business and market development for VisionCare Ophthalmic Technologies.

For more information, go to VisionCare Ophthalmic Technologies, Inc.'s Web site at www.visioncareinc. net/technology.html.