at press time

New TLC Vision Clinic Treats Dry AMD
Canada OKs Blood Filtration Device; U.S. Trials Continue.

TLC Vision, a Canadian com pany best known for operating laser vision correction centers, has opened the first facility in North America that uses a patented rheopheresis blood filtration process to treat the dry form of age-related macular degeneration (AMD).

A new TLC Vision subsidiary, Rheo Clinic Inc., began treating patients on a private-pay basis in late November at its Rheo Clinic in Mississauga, Ontario, after Health Canada approved the Rheofilter blood filtration device. Patients, who must be in good general health, undergo an initial series of eight 2-hour treatments over a period of 8 to 12 weeks. An annual "booster" treatment is also recommended. Cost of the initial series is about $15,000 in U.S. dollars.

"Rheopheresis treatment for dry AMD is in a pivotal Phase III clinical trial in the United States right now," says Stephen Kilmer, spokesperson for TLC Vision. "Twelve-month data from this trial indicate that the treatment has stopped the progression of the disease in 94% of patients. Patients receiving rheopheresis have demonstrated a mean vision gain of 1.1 lines of EDTRS BCVA at 12 months post-baseline, compared with a mean vision loss of 1.9 lines in the placebo group, a 3-line difference between treated and placebo eyes."

	Patients with the dry form of AMD undergo the 2-hour rheopheresis blood filtration procedure that eliminates high-molecular-weight proteins and lipoproteins.

Kilmer further notes that 15.8% of eyes treated with rheopheresis in the Phase III study showed vision improvement of at least 3 lines EDTRS BCVA and continued to maintain this level of vision gain at 12-months post-baseline. None of the eyes in the placebo group demonstrated a vision gain of this magnitude.

"Given these preliminary results, we anticipate filing a pre-market approval application for rheopheresis in the United States in late 2003 or early 2004," says Kilmer.

In addition to developing, owning and operating its own Rheo Clinic centers, TLC Vision has formed a joint venture with Vascular Sciences Corp. to commercialize rheopheresis technology throughout North America. The joint venture, OccuLogix LP, intends to sell the proprietary Rheofilter MDF blood filtration system to hospitals and other qualified health providers who wish to offer the treatment.

"Rheopheresis offers hope to people who had very little in the way of treatment options before," says Kilmer. "With very little publicity, we've already had hundreds of inquiries from people who either want the treatment themselves, or who have parents afflicted with AMD."

The dry form of AMD currently affects more than 10 million Americans, with a million new cases diagnosed each year.

Patients with the dry form of AMD undergo the 2-hour rheopheresis blood filtration procedure that eliminates high-molecular-weight proteins and lipoproteins. 

Eye Surgeons Caught Up in Patent Battle
Hundreds Subpoenaed to Provide Procedure Information.

Patent infringement lawsuits filed by one company against another are a common occurrence in ophthalmology. However, until recently, physicians have been spared from involvement in these company vs. company battles.

But the current litigation between Nidek and VISX, Inc., over excimer laser patents represents a new escalation in ophthalmology-related patent infringement lawsuits. With each company suing the other over patent rights, both VISX and Nidek have subpoenaed hundreds of refractive surgeons to obtain each surgeon's procedure volume and other related information. VISX estimates that, as part of the discovery process in its lawsuit against Nidek, it's subpoenaed more than 100 Nidek users since 2000. Nidek, which filed a counter-claim against VISX, just recently issued subpoenas to 608 VISX laser users.

The prospect of refractive surgeons being overburdened by the latest round of subpoenas has caused the American Society of Cataract and Refractive Surgery (ASCRS), the American Academy of Ophthalmology and the Ophthalmic Mutual Insurance Company to band together to attempt to quash the Nidek subpoenas, or at least minimize the amount of information required from the doctors. John Ciccone, director of communications for ASCRS, says the organizations' position is that "the litigants should settle this themselves and leave our members out of it."

Spokespersons for both VISX and Nidek say their companies were reluctant to involve the refractive surgeons in the legal battle, but say the procedure information is necessary to accurately determine the extent of damages if a court rules that a patent has been infringed.

Stargardt's Doesn't Stop Football Star
Wofford's Goodpaster Excelled Despite Being Legally Blind.

It was tough enough for little Wofford College's football team to even take the field in 2001 against Division 1-A powerhouse Clemson. It was even tougher for Wofford's top wide receiver, Isaac (Ike) Goodpaster, who has 20/200 vision from Stargardt's disease, the most common form of juvenile macular degeneration.

Goodpaster scores at Clemson.

Despite a lifelong visual handicap that has him classified as legally blind, Goodpaster caught a touchdown pass in Wofford's 38-14 loss to Clemson. That was only one of 25 catches for a total of 422 yards that the speedy Goodpaster made during the 2001 season.

Goodpaster is now a senior at Wofford, a little-known center of academic excellence located in Spartanburg, S.C. He recently completed his football career as his team compiled a 9-3 record in 2002, but doesn't view what he's done on the gridiron as particularly special.

"I look at myself as any other person," he told the Associated Press. "That's how I live my life."

Though his vision can't be improved by glasses or contact lenses, Goodpaster has been able to follow a football by cocking his head and using his stronger peripheral vision to line up the catch.

A three-sport star in high school in Kentucky, Goodpaster is also considered one of the best ping-pong players on the Wofford campus. He's earned a 2.9 grade-point average as a business/economics major by using large-print books, textbooks on tape and special computer software programs. He also has a driver's license.

"I can't explain how I do everything I do," Goodpaster says. "I just do it."

IN THE NEWS

Vistakon/1-800 Contacts agreement. 1-800 Contacts, a mail-order supplier of contact lenses, has reached an agreement with the Vistakon division of Johnson & Johnson Vision Care that will enable 1-800 Contacts to become an authorized retailer of Vistakon lenses.

As part of the agreement, 1-800 Contacts will modify its systems to give eyecare providers a minimum of 8 business hours to respond to its prescription verification requests. Eyecare providers will have the option of receiving these requests by fax. If the eyecare provider notifies 1-800-Contacts within this time period that the customer's prescription is expired or otherwise invalid, the order won't be shipped. Absent such notification, 1-800 Contacts will proceed with the sale based on the prescription that was communicated to the provider. This system will apply to Vistakon orders nationwide, with the exception of a few states in which 1-800 Contacts has pre-existing agreements to apply more stringent procedures.

"This agreement ensures that eyecare professionals are actively involved in their patients' eye care by actively controlling their patients' prescriptions," said Phil Keefer, president, Vistakon Americas. "We are confident that the terms of this contract establish a safe and well-structured ordering policy -- one that raises the standards for ensuring patients receive Acuvue brand contact lenses only based on a valid prescription."

Clinical trial. GenVec, Inc. has begun a Phase I clinical trial for its AdPEDF treatment for wet AMD. AdPEDF employs the antiangiogenic properties of Pigment Epithelium-Derived Factor (PEDF) to prevent new blood vessel formation. The company says preclinical testing has demonstrated that AdPEDF may also be effective against already existing abnormal blood vessels.

REFRACTIVE SURGERY UPDATE

Late adopters. Refractive surgeons who perform both LASIK and LASEK report that patients who choose LASEK are demonstrating classic "late adopter" tendencies. These cautious patients try to learn as much as possible about the advantages and disadvantages of various vision-correction procedures before making a decision. They fear complications and tend to ask their surgeon numerous questions, and they may take months before making a final decision to proceed with the surgery.

John Pinto, a consultant to ophthalmic practices, says late adopters can be difficult to serve and notes that the conversion rate from consult to surgery is lower than with early adopters. He says one of the best ways to reach late adopters is to use an advertising message such as: "You've known for years that you want to reduce your dependence on glasses and contacts. But you've held back, waiting for the surgery to be refined. Well, your wait is over."

Another effective ad message, suggests Thomas V. Claringbold II, D.O., of the MidMichigan Physicians Group in Clare, Mich., is: "If you've wanted better vision but weren't a good candidate for LASIK, LASEK may be right for you."

VISX drops Medjet. VISX, Inc., a developer and manufacturer of excimer lasers used in vision correction, said it's ending its association with Medjet, Inc., which has been developing a technology that uses high-pressure, controlled jets of water to cut flaps for LASIK. VISX will pay Medjet a $250,000 break-up fee to terminate the partnership.

Microkeratome recall. Alcon has voluntarily recalled its SKBM microkeratome after receiving reports of a small number of patient injuries caused by a loosened or misaligned applanation glass on the head of the handpiece. Alcon obtained the SKBM as part of its acquisition of Summit- Autonomous Technologies, Inc. and estimates that about 350 SKBM units are in use worldwide.

TICL gets CE Mark. STAAR Surgical's Toric Implantable Contact Lens (TICL) has received the CE Mark, making it the first posterior chamber toric phakic IOL approved for sale in the countries of the European Union. The TICL can reduce pre-existing astigmatism and provide correction of myopia or hyperopia.