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CIBA Vision Markets Mini Glaucoma Shunt
Device Is Implanted in Minimally Invasive Procedure.

The diagram above illustrates how the Ex-Press mini glaucoma shunt works in the eye to divert excess aqueous humor from the anterior chamber to lower intraocular pressure.

CIBA Vision has obtained the exclusive rights to market the Ex-Press mini glaucoma shunt in the United States and Canada. The device, developed by Optonol Ltd., is now available in this country, with CIBA Vision offering a training and certification program for eye surgeons.

The Ex-Press is a 400-micron diameter tube made from implantable stainless steel and loaded on a specially designed disposable inserter. Implanted through a small incision in the conjunctiva in a minimally invasive, 5-minute procedure, the Ex-Press reduces IOP by diverting excess aqueous humor from the anterior chamber to a subjunctival bleb.

According to CIBA Vision, implantation of the Ex-Press requires minimal manipulation, with no iridectomy, scleral dissection or cauterization required.

The Ex-Press has the CE Mark and has been marketed in Europe by Optonol for more than a year, with approximately 1,000 patients already treated. The product received FDA marketing clearance in March.

In a multicenter study evaluating the safety and efficacy of the Ex-Press mini shunt, researchers found the device effective in reducing IOP by an average of 40% after 1 year without intra-operative usage of antimetabolites. Approximately 88% of the patients in the study saw a reduction in their IOP to less than 21 mmHg.

"The beauty of this procedure is its simplicity and effectiveness," says Robin Terrell, president of CIBA Vision's Surgical business. "The Ex-Press shunt is minimally invasive when compared to current surgical procedures for glaucoma."

New Studies Begin for Three Wet AMD Therapies
One Trial Will Assess More Frequent Visudyne Treatments.

Three important new Phase III clinical trials are now under way as part of the effort to find more effective treatments for wet age-related macular degeneration (AMD):

Novartis Ophthalmics and QLT Inc., the co-developers of verteporfin for injection (Visudyne), have completed patient enrollment in a study to evaluate the effectiveness of more frequent Visudyne treatments in slowing or halting the progression of wet AMD. Visudyne is currently the only drug that's been approved by the FDA for treatment of some forms of wet AMD.

The study will compare the standard regimen of Visudyne therapy (a treatment every 3 months) to a more frequent regimen of every 6 weeks for the first 6 months of treatment. A total of 323 patients at 31 sites throughout the United States and Europe are participating in this trial.

"In this trial, we hope to confirm the anecdotal evidence that being more aggressive in the early phase of treatment improves vision outcome and reduces disease progression," said Michael Stur, M.D., associate professor of ophthalmology at the University of Vienna and principal investigator for the trial.

Results are expected to be available late next year.

In related news, Visudyne was recently approved by the European Commission for the treatment of occult subfoveal choroidal neovascularization associated with wet AMD.

Eyetech Pharmaceuticals has completed enrollment of patients in two Phase III trials of Macugen, the company's treatment for wet AMD. The two studies, which encompass 1,196 patients at 117 sites around the world, are the largest ever undertaken for wet AMD.

Macugen is an aptamer that binds to and neutralizes Vascular Endothelial Growth Factor. Macugen is being studied as both a stand-alone treatment and in combination with photodynamic therapy.

Alcon is enrolling patients in a new trial of Anecortave Acetate. The study will compare vision outcomes of patients treated with Anecortave Acetate to those treated with Visudyne. Anecortave Acetate is designed to stop blood vessel growth behind the retina by preventing production of certain enzymes that aid in the formation of new blood vessels.

O.D.s Rebuffed in Vermont and Alaska
Scope of Practice Legislation Is Defeated.

Ophthalmologists continued to have success in turning back optometrists' attempts to expand their scope of practice, with the latest victories in Vermont and Alaska. Earlier this year, similar optometric efforts were rejected in Georgia, Mississippi, Minnesota and South Dakota.

In Vermont, the optometry lobby had backed a bill that would have given O.D.s the authority to prescribe all pharmaceutical agents for the diagnosis, management and treatment of the eye and adnexa. In addition, the legislation would have allowed O.D.s to treat glaucoma and perform injections.

Optometrists argued that they needed to expand their scope of practice because Vermont has a large rural population that has difficulty readily accessing ophthalmologic care. The state's department of health commissioner, Jan Carney, M.D., told the legislature that she had investigated the eyecare access situation in the state and found no significant problems.

In Alaska, the optometry lobby supported a bill allowing O.D.s to prescribe all therapeutic oral drugs and perform all injection procedures. This legislation was rejected by both the Alaska State Senate Health, Education and Social Services Committee and the state legislature.

In both Vermont and Alaska, state ophthalmological societies joined with the American Academy of Ophthalmology to defeat the proposed legislation.

REFRACTIVE SURGERY UPDATE

Toric ICL implanted. STAAR Surgical Company announced that the U.S. clinical study for its toric implantable contact lens (TICL) has begun. The company said John Vukich, M.D., of the Davis Duehr Dean Medical Center in Madison, Wis., implanted the first lens in a severely nearsighted patient (-10.25D) with significant astigmatism (+4D). At 24 hours post-op, the patient's vision had improved to a level good enough to pass a driving test without glasses.

The U.S. clinical study for the TICL, a posterior phakic IOL, will include 125 patients with 1-year follow-up.

Refractec gets funding. Refractec, Inc., the developer of conductive keratoplasty (CK) for treating hyperopia, has received additional venture capital funding to expand the launch of its ViewPoint CK System in the United States. The company said that since CK was approved by the FDA in April, procedure volume has exceeded expectations. CK utilizes the controlled release of radiofrequency energy to reshape the cornea.

LADARVision study. A recent multicenter study involving 360 eyes shows that LASIK performed using the LADARVision eye-tracking system is both safe and effective for farsightedness, farsighted astigmatism and mixed astigmatism. At 1 year, uncorrected visual acuity of 20/40 or better was achieved by 93.9% of patients treated for farsightedness, 93.8% of those treated for farsighted astigmatism and 94.4% of those treated for mixed astigmatism.

LaserSight shipments. LaserSight Inc., a developer of laser vision correction technology, has begun shipping product to its partner in China, Shenzhen New Industries. The companies finalized an agreement that calls for Shenzhen New Industries to buy $10 million of LaserSight equipment over the next 12 months. The order includes LaserScan LSX excimer laser systems, AstraMax diagnostic workstations and UltraShaper microkeratomes and blades.

Antitrust settlement. LCA-Vision, a provider of laser vision correction services, said it has received a $2.28 million settlement in an antitrust class action suit against laser manufacturers. The suit charged that Pillar Point Partners, a joint entity formed by VISX Inc. and Summit Technology in 1995, had engaged in anticompetitive practices. Pillar Point partners was dissolved in 1998 after the Federal Trade Commission challenged its existence.

Intacs in Europe. Addition Technology, Inc., the maker of Intacs prescription inserts for surgical vision correction, has requested authorization to market a wider product line in Europe. The company is seeking approval to provide six additional inserts in smaller increments of correction within the currently approved range of -1 to -5D.

IN THE NEWS

CEO resigns. Thomas F. Motter, the CEO and chairman of the board of directors of Paradigm Medical Industries, Inc., resigned suddenly on Sept. 3. On the same day, the company's president and chief operating officer, Mark R. Miehle, was removed by the board. Heber C. Maughan, Paradigm's chief financial officer, was named interim CEO. No explanation was given for the changes in senior management at the time of the resignations, but on Sept. 13 the company board of directors said it had reviewed a previously announced $70 million order from Latin America and found that no firm order for Paradigm products existed. Paradigm stock, which had dropped to 50 cents a share after the Motter resignation, tumbled further after the Sept. 13 announcement.

Lawsuit filed. CIBA Vision has filed a lawsuit in U.S. District Court against two Georgia companies that CIBA Vision claims have been selling color contact lenses without prescriptions. CIBA Vision notes that all contact lenses, whether used for vision correction or merely to change eye color, are regulated as medical devices by the FDA and require a prescription. The suit names C&C Trading and MAS Wholesale & Retail as illegally selling CIBA Vision lenses.

Awareness campaign. Vistakon has launched a campaign to educate Hispanic-Americans on the importance of vision care, a health issue that's often neglected by this community because of the lack of Spanish-language eye health information. As part of the campaign, a network of Spanish-speaking eyecare professionals has been formed to provide information at the community level. Vistakon is also launching a Spanish-language eyecare Web site and sponsoring Hispanic festivals in Miami, Los Angeles and New York. Hispanics age 40 and older are at high risk for developing glaucoma and diabetic retinopathy.

Inoveon gets financing. Inoveon Corporation has received $16 million in venture capital financing to continue the development of its 3DT retinal scanning service to detect, track and manage patients with diabetic retinopathy. With this system, patients would go to a local Inoveon Patient Service Center to be scanned. The resulting images would then be evaluated and analyzed, with a disease management report returned to the patient's physician within 48 hours.

Antibiotic partnership. Bausch & Lomb will participate in the development of InSite Vision's ISV-403 sustained-release antibiotic for treating ocular bacterial infections. InSite Vision says preclinical studies indicate that the drug is effective against bacteria that are resistant to currently marketed fluoroquinolone products. The agreement makes InSite Vision responsible for the clinical development of ISV-403, while B&L will handle commercial manufacturing and marketing.

Artificial iris. Ophtec USA has begun a clinical trial for its artificial iris implant for the treatment of congenital or traumatic aniridia. The first procedure in the study was performed in early August by Francis W. Price, M.D.

Patent ruling. CIBA Vision has been granted a summary judgment by a U.S. District Court in its patent infringement lawsuit against CooperVision. The ruling affirms that CooperVision's Frequency Colors contact lenses infringe a patent that protects the color technology of the FreshLook brand of contact lenses. A trial date has been set for later this year.

On the board. Stephen J. Ryan, M.D., has been named to the board of directors of Allergan, Inc. Dr. Ryan, an expert in retinal diseases and ocular trauma, is dean of the Keck School of Medicine and senior vice president for medical care at the University of Southern California.

Artisan Phakic IOL Proves Effective in Trials
Lens Exhibits Advantages over LASIK for Moderate-to-High Myopia.

Two recently published studies indicate that Ophtec's Artisan phakic IOL is safe and effective in treating moderate-to-high myopia, offering visual results that are overall superior to LASIK.

	Ophtec's Artisan lens

The Artisan has been in use internationally for several years and is currently in Phase III trials in the United States.

In an FDA-approved clinical trial conducted in the United States, the Artisan lens was implanted in 155 eyes of 155 patients with -5.5D to -22.5D of myopia. At 6 months, 85% of eyes saw 20/40 or better, and astigmatism decreased in 17% of the eyes. Astigmatism increased in 4.8% of the eyes, while four of the eyes developed nonprogressive haze in the lens. None of the eyes developed chronic inflammation, glaucoma or other serious complications.

In a second study, conducted in France, 25 patients with -8D to -12D of myopia had the Artisan lens implanted in one eye and received LASIK in the other. Though visual outcomes were similar for both types of correction, the Artisan lens scored higher in best-corrected visual acuity and in a subjective quality-of-vision evaluation.

Robert K. Maloney, M.D., lead author for the U.S. clinical trial, attributed the better performance of the Artisan lens to its superior optics and better refractive accuracy. However, he cautioned that these advantages should be weighed against the relatively greater risk of an intraocular procedure vs. LASIK.

Use Caution in Offering Patients Cash Discounts
You Could Easily Run Afoul of the Law.

When can you offer a cash discount to a patient?

Only under certain limited circumstances, says Anna Spencer, a senior associate with the Washington, D.C., law firm of Arent Fox, which represents a number of ophthalmology practices.

Although cash discount arrangements are permitted in some situations, the improper use of cash discounts can lead to violations of a number of state and federal laws, notes Spencer.

Spencer says that the most appropriate way to use cash discounts is to give them to patients who pay the bill out of their own pocket. The discount serves as a way of recognizing the considerable savings in time and money that a practice achieves when a claim doesn't need to be submitted to a third-party payer. You're on safe legal grounds when you give a discount to a "self-pay" patient, providing that the patient doesn't pay less than Medicare-allowable rates and the discount doesn't violate state insurance discrimination prohibitions.

Spencer says that practices are most likely to run afoul of the law when they offer cash discounts to patients who are covered by health insurance. In many of these cases, the term "cash discount" is used to improperly waive an "out of the network" penalty required by a patient's managed care insurance.

A potential problem with cash discounts for Medicare patients involves the HIPAA anti-patient-inducement penalty provision. This provision makes it unlawful to offer any benefit, including a discount, to a patient if it's likely to have any effect on the patient's choice of provider, except where the changed pricing is a waiver, based on the good faith financial need of the patient.

Providers can also run into trouble by submitting Medicare or private insurance claims that don't explicitly report cash discounts given to patients. Such claims can result in excessive reimbursement to the practice, violating federal and state false claims acts and/or state insurance fraud statutes.

Discounts raise a host of potential issues that can lead to stiff penalties for providers, concludes Spencer. If you now offer -- or plan to offer -- cash discounts, have an attorney who specializes in healthcare regulations carefully review your policies.

Court Decision Creates Opportunity for CIBA Vision
Company Seeks Converts to its 30-Day Continuous Wear Contact Lenses.

A few months ago, it appeared that CIBA Vision's Focus Night & Day contact lenses and Bausch & Lomb's PureVision lenses were going to engage in a spirited head-to-head competition to gain market share in the fast-developing market for 30-day and night continuous wear silicone hydrogel contact lenses.

But that all changed in July when the United States Court for the District of Delaware ruled that the B&L product infringed on CIBA Vision's patent covering silicone hydrogel materials used in contact lenses. The court ordered Bausch & Lomb to immediately discontinue the manufacture and sale of PureVision lenses in the United States until at least 2005, the year CIBA Vision's patent expires.

A Bausch & Lomb spokesperson said the company is currently appealing that ruling and believes B&L has a "strong case" to have the District Court decision reversed.

With PureVision wearers at least temporarily deprived of a continuing source of replacement lenses, CIBA Vision saw an opportunity to gain more converts to its Focus Night & Day product. In a two-pronged marketing approach, CIBA Vision in September began to offer discounts to doctors who stocked up on Focus Night & Day lenses while at the same time providing $25 rebates to patients who need to be refitted.

"We want to do all that we can to assist eyecare practitioners in enabling their patients who have enjoyed the benefits of continuous wear to continue to do so by transitioning to Night & Day lenses," says Stephen Osbaldeston, president of CIBA Vision North America.

With CIBA Vision now having the only 30-day and night continuous wear silicone hydrogel contact lens on the U.S. market, the company has already doubled production of Focus Night & Day lenses and is investing in new facilities to increase production fourfold by 2004.

Eye Care Says Farewell to Two Leaders
The Contributions of Drs. George W. Mertz and Donald Johnson Were Many.

Dr. George W. Mertz

George W. Mertz, O.D., FAAO, director of academic affairs in the Professional Affairs Division of Vistakon for the past decade, died on Sept. 14. He had been involved in clinical research and professional education in the contact lens industry throughout his career. Dr. Mertz was 56.

He had been employed at the Vistakon Division of Johnson & Johnson Vision Care, Inc., since 1990, initially as manager of clinical research/product analysis in the R&D division. In his most recent position, he was responsible for the company's programs at academic institutions involved in the training of future eyecare professionals.

At the time of his death, Dr. Mertz was serving as president of the American Optometric Foundation.

Dr. Donald Johnson

Donald Johnson, M.D., 60, a world-renowned Canadian eye surgeon who was considered to be the first ophthalmologist in North America to devote his practice solely to refractive surgery, died in a traffic accident recently in his home town of Surrey, British Columbia.

He performed laser vision correction surgery on more than 50,000 patients from 30 countries and every U.S. state. He was best known for developing what he called the "no touch" technique for laser vision correction. The "no touch" technique is essentially an advanced form of PRK that involves the use of a laser, but no microkeratome. Dr. Johnson used this method instead of LASIK because he felt it greatly reduced the possibility of complications.