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Bausch & Lomb Reports Positive Envision Results
Drug-Delivery Implant Is Effective in Initial Phase III Trial.

Implant is about the size of a grain of rice.

Bausch & Lomb said results from the first Phase III study of its Envision TD technology show "statistically significant" reduction in macular edema and in the severity of diabetic retinopathy in patients implanted with the proprietary drug-delivery system.

In addition, of the total of 80 patients participating in the study, more of those who received the implant show improved or stabilized visual acuity compared with patients treated with macular grid laser or observed.

The FDA has granted Envision TD fast-track status, allowing Bausch & Lomb to file a new drug application for the implant as early as next year.

	The implant is positioned in the back of the eye.

In the initial phase of a planned 4-year study, sustained and consistent levels of fluocinolone acetonide were delivered to the affected area of each patient's eye for 6 months through a tiny drug reservoir implanted in the back of the eye. Each implant is capable of delivering the drug for up to 3 years.

According to Bausch & Lomb, researchers found no major differences in serious ocular adverse events between implant-treated patients and those receiving standard of care. Adverse events, which included cataracts, vitreous hemorrhage, retinal neovascularization and ocular hypertension, affected 15% of the implant-treated patients and 18% of those in the standard of care group. No patients required implant removal, and none withdrew from the study due to an adverse event, the company said.

"To have achieved statistical significance in the reduction of macular edema, the primary endpoint of the study, as well as a reduction in the severity of diabetic retinopathy, is very important from a clinical perspective," said Michael Ip, M.D., of the University of Wisconsin, one of the investigators in the trial.

"These results certainly reinforce our confidence in this technology platform and our commitment to pursue its potential by providing the focus and resources to bring it to market," said Ronald L. Zarrella, chairman and CEO of Bausch & Lomb.

IN THE NEWS

Dry eye treatment. Inspire Pharmaceuticals achieved its primary objective endpoint -- statistically significant reduction of corneal staining after 6 weeks -- in the second Phase III trial for its INS365 Ophthalmic treatment for dry eye. The primary subjective endpoint -- statistically significant clearing of foreign body sensation in the eye after 6 weeks -- was approached, but not met. These mainly positive results differ markedly from the first INS365 Phase III trial, a 12-week study in which neither of the two primary endpoints were met.

Low-vision coverage. The Centers for Medicare and Medicaid Services has approved nationwide Medicare coverage of physician-prescribed vision rehabilitation services delivered by approved health care professionals. Previously, coverage of these services was determined on a state-by-state basis.

Positive recommendation. A panel that evaluates new drug applications for the European Commission has recommended approval of verteporfin for injection (Visudyne) for the treatment of occult wet AMD in patients with evidence of ongoing disease progression. The European Commission is expected to make a final ruling on this recommendation within the next 3 months. The U.S. Centers for Medicare and Medicaid Services recently said Medicare wouldn't cover Visudyne for treatment of the occult form of wet AMD.

New IOL design. CIBA Vision Surgical will launch its CV232 Square-Round-Edge IOL in the United States later this year. The posterior square edge of the lens facilitates 360-degree capsular contact. But unlike some square-edge lenses, the CV232 has a rounded anterior edge intended to minimize glare. The pre-rolled CV232 lens doesn't require a folder or injector.

Eye Drops Can Delay Glaucoma Onset
Ocular Hypertension Treatment Study Shows Good Results in At-Risk Patients.

Eye drops used to treat elevated IOP can be effective in delaying the onset of glaucoma in some patients. The drops may even prevent the disease in these individuals.

That's the key finding of the Ocular Hypertension Treatment Study (OHTS), which for 5 years followed 1,636 people age 40 through 80 who had elevated IOP but no signs of glaucoma. Half of the participants received daily eye drops. The other half got no medication. In the treatment group, the average IOP reduction was 20%. Results of the study were recently released by the National Institutes of Health, one of the study's primary sponsors.

Researchers found that commercially available, pressure-lowering eye drops reduced by more than 50% the development of primary open-angle glaucoma. They noted that only 4.4% of the study participants who received eye drops developed glaucoma within 5 years. By comparison, 9.5% of the study participants who didn't receive the eye drops developed the disease. Additionally, several significant risk factors were found to be associated with the development of glaucoma in study participants, including advanced age, African descent, higher IOP and certain ocular characteristics such as thin corneas.

"This study shows that treating elevated eye pressure delays or prevents the onset of glaucoma in some people," said Paul A. Sieving, M.D., Ph.D., director of the National Eye Institute. "However, not all people with elevated eye pressure should be treated with the eye drops. Patients at risk for glaucoma still need a comprehensive eye exam to determine if eye drops might help."

Michael Kass, M.D., chairman of the study, noted that 90% of those individuals who were only observed didn't develop glaucoma within the 5-year period. He said doctors should take several factors into account before prescribing eye drops, including patients' risk of developing glaucoma, their health status and life expectancy.

"The burden of daily treatment, including cost, inconvenience and possible side effects, should also be discussed with the patient," he said.

Pharmacia Corporation donated latanoprost ophthalmic solution (Xalatan) to the 22 study sites across the United States. The study sites were permitted to treat patients with all commercially available topical ocular hypotensive therapies.

In an unrelated survey sponsored by Santen Incorporated, only 27% of 2,000 respondents said they have heard of ocular hypertension. Only 7% of those who were aware of ocular hypertension know that it has no symptoms.

Ophthalmologists Offer Their "Vision" to Voters
Two Run for U.S. House. Another Eyes the Senate.

Ophthalmologists from Louisiana, Pennsylvania and New Jersey, each with major-party backing, are seeking to win election to national office in November.

• John Cooksey, M.D., a conservative Louisiana Republican who has already served three terms in the U.S. House of Representatives, is giving up his House seat to run for the Senate.
• Melissa Brown, M.D., a Republican who's fiscally conservative but liberal on social and women's issues, will be seeking to unseat the Democrat incumbent in a district that takes in northeast Philadelphia and nearby suburbs. Dr. Brown, making her second run for Congress, won her primary election in May.
• Anne Sumers, M.D., formerly a moderate Republican and now a Democrat, is running for the House seat being vacated by Rep. Marge Roukema. Roukema, a moderate Republican, chose not to seek re-election in New Jersey's Fifth Congressional District, which encompasses parts of Bergen County, including the cities of Paramus and Ridgewood.

John Cooksey, M.D.

Melissa Brown, M.D.

Anne Sumers, M.D.

While it's unusual that three physicians representing the same specialty are running for national office at the same time, the candidacies should be considered more than a curiosity. Noting that only eight physicians now serve in the House and one in the Senate, the American Medical Association (AMA), through its political action committee, is now providing training courses for physicians who desire to run for public office. The president of the AMA recently wrote that more physicians are needed in Congress (and in other areas of public life) to provide better representation on issues important to the medical community.

During his tenure in the House, Dr. Cooksey has introduced legislation intended to reduce the number of Americans without medical insurance and put patients more in control of healthcare decisions. Before being elected to public office, he was instrumental in helping Louisiana to pass what's been called a model medical malpractice law.

Dr. Brown, a former nurse, is on the faculty of the Cataract and Primary Eye Care Service of Wills Eye Hospital in Philadelphia. She's also the co-chief editor of Evidence-Based Eye Care, a journal that analyzes clinical studies and patient histories in an effort to identify the most effective and efficient treatment methods. Dr. Brown also serves as president of the Montgomery County (Pa.) Medical Society.

Dr. Sumers comes from a family with a long history of public service. Her grandfather served in Congress and her great-grandfather was governor of Massachusetts. She's been in private practice in Bergen County since 1987. and is also the team ophthalmologist for the New York Giants. Dr. Sumers says one of her major reasons for running is to obtain affordable, quality health care for all Americans. She says she's especially attuned to the shortcomings of Medicare and the health problems of senior citizens.

REFRACTIVE SURGERY UPDATE

Procedure prediction. TLC Vision (the new company formed through the merger of TLC Laser Eye Centers and Laser Vision Inc.) estimates that overall refractive surgery volume in North America this year will be about equal to last year's approximately 1.3 million procedures. However, the company does predict 11% growth in procedures in 2003.

Patent licensed. LaserSight Inc. has licensed its '504 scanning patent, which encompasses precision microspot scanning technology, to Alcon on a nonexclusive basis for a lump sum payment of $2 million. LaserSight has also licensed the '504 patent to Bausch & Lomb.

No sale. LaserSight Inc. announced that the planned sale of the company's AstraMax technology to an unnamed buyer has been called off. AstraMax, designed to be used in custom ablation procedures, is an integrated refractive diagnostic workstation that performs analysis of aberrations within the eye.

Technolas approval expanded. The Bausch & Lomb Technolas 217A Laser System has been approved by the FDA for treating moderate-to-high levels of myopia. The new approval allows surgeons to use the Technolas system to correct myopia with astigmatism of up to -12D (manifest refractive spherical equivalent), and sphere between -7D to -10.99D and cylinder less than -3D. The Technolas system was originally approved for the treatment of mild-to-moderate myopia of up to -7D.

VISX sues. VISX Inc. has filed suit in Germany against WaveLight Laser Technologie AG for infringing on a VISX patent. WaveLight is a German manufacturer of vision correction lasers.

SurgiLight CEO. SurgiLight, a developer of ophthalmic laser systems, has named Colette Cozean, Ph.D., its new CEO.

Roger Martin Leads Crusade for Glaucoma Screenings
He Wants to Get More Ophthalmologists Involved.

Martin at a Washington, D.C., screening.

In 1997, Roger Martin was running a failing restaurant in Connecticut. Today, he's leading a nationwide, grassroots movement whose goal is to offer free glaucoma screenings to as many "at risk" individuals as possible. Partnering with Lions Clubs International and Allergan, Martin heads an effort that resulted in 8,000 screenings in the first 3 months of this year.

Martin's transformation from restaurant operator to full-time vision care advocate began when he took his mother to her ophthalmologist in 1997 to have her glaucoma treated. The ophthalmologist, Robert Ritch, M.D., suggested that Martin should also be examined because of his family history. Sure enough, Martin had glaucoma.

"Shortly after I was diagnosed, I heard a doctor on an Oprah show say that the most positive, life-changing experiences can develop out of a disease," recalls Martin. "That was absolutely true for me. I closed the restaurant and decided to devote my life to conducting screenings that could help detect glaucoma and other eye diseases."

Using his own money and equipment borrowed from Dr. Ritch, Martin set out on his mission. He joined the Lions Club, an organization that already has a major commitment to better eye health, and helped develop a Lions Club screening program in Connecticut.

Today, after 5 years of crisscrossing the country and screening approximately 46,000 people in senior centers, shopping malls and churches, Martin has the corporate sponsorship and funding he needs to continue his work. But he'd like to see more ophthalmologists get involved in grassroots glaucoma screening, particularly in underserved African-American and Hispanic communities in which a high percentage of the population is at risk for glaucoma and other eye diseases.

"Get involved with your local Lions Club," he advises. "Lions Clubs International has given our Connecticut screening program pilot status for the entire country and will be mobilizing local Lions to help you in such areas as scheduling and publicizing screenings, handing out flyers, and assisting you at the actual screening sessions."

Martin says once people agree to be screened, it's a lot easier to get them into the office for a full examination and diagnosis.

"Reaching out to the community and being recognized as a doctor who really cares will not only make you feel good, it will help you build your practice," concludes Martin. "In this instance, doing good can lead to doing well."

Eye MDs Win Major Victory in Florida
"Double Gatekeeping" Is Banned.

The Florida legislature has ended a practice called "double gatekeeping," which allowed managed care plans to force patients with eye problems to see an optometrist before being permitted to be examined by an ophthalmologist.

The Florida Society of Ophthalmology, the Florida Medical Association and the American Academy of Ophthalmology (AAO) led the fight to strike down a state law that had permitted double gatekeeping. They argued that the system was costly, time consuming, redundant and possibly harmful to eyecare patients. With double gatekeeping, primary care physicians had to first send patients with eye problems to an optometrist, even if they felt the patient's medical needs would be best served by seeing an ophthalmologist.

Under the new state law, if a Florida primary care physician under contract with a managed care plan decides that a patient would be best served by seeing an ophthalmologist, the plan must approve his choice without first having it vetted by an exam conducted by an optometrist.

"This is a major victory for the consumers and patients of Florida which will eliminate costly and duplicative delays in care for patients with eye conditions," said Richard Shugarman, M.D., president of the Florida Society of Ophthalmology.

"This patient rights victory orchestrated by the Florida Society of Ophthalmology serves notice that state ophthalmology societies will champion a just cause at the state capital," added Michael Brennan, M.D., AAO secretary for state affairs.