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TIPS AND NEWS YOU CAN USE

Cataract Surgeons Seek Alternatives to Wydase
Wyeth-Ayerst Ends Production of Anesthetic Dispersal Agent.

Because a 70-year-old manufacturing facility in Marietta, Pa., no longer meets FDA standards, a widely used drug that rapidly and effectively disperses anesthesia during cataract and other intraocular surgery may never be produced again.

Wyeth-Ayerst, which has been the only supplier of hyaluronidase (Wydase), has put its remaining inventory of the drug on strict allocation and is soon expected to make its final shipments. A company spokesperson says Wyeth-Ayerst has no plans to produce the drug in the future.

"There have been discussions about finding a new supplier, but there's nothing definite on the horizon," says Jane Aguirre, vice president of ophthalmic practice for the American Academy of Ophthalmology (AAO).

The AAO is currently preparing a booklet it will distribute to members outlining possible alternatives for cataract surgeons, including:

• stretching the existing supply of Wydase by using the drug in significantly decreased concentrations. Some surgeons have reported good results using one-third of the Wydase they've used in the past.
• using a topical anesthesia such as bupivacaine (Marcaine) or lidocaine. However, this alternative is not for everybody. Some patients require a regional block to prevent unwanted eye movement during surgery.
• using a sub-Tenon's infusion rather than a retrobulbar or peribulbar injection to create a safe regional block without the use of Wydase.
• acquiring a supply of hyaluronidase from a compounding pharmacy. The AAO warns that there may be quality-control issues with compounding pharmacies.

"Finding good, safe alternatives to Wydase is a major concern," concludes Aguirre. "Following a previous shortage in 1998, there was at least one paper published that noted increased instances of double vision in surgeries performed without Wydase." 

Paradigm Medical Industries, Inc. has been awarded a license to commercialize a new, as yet unapproved medication whose primary purpose is to promote post-LASIK healing and prevent haze. The company says the eye drop, a form of plasminogen activator, has the potential to be used following every corneal procedure.

The drug is being developed by Johns Hopkins University.

"A urokinase plasminogen activator enzyme occurs naturally in tears," says David Silver, Ph.D., principal staff senior scientist at the Johns Hopkins Applied Physics Laboratory and co-inventor of the drug. "Our study of 42 photorefractive keratectomy (PRK) patients showed that, for most patients, the concentration of this enzyme drops to almost zero immediately following surgery and takes 3 to 5 days to return to normal levels. However, the plasminogen activator level remains low for a longer period in those few patients who develop haze. By giving this medication -- on a prophylactic basis -- to every patient who undergoes a corneal procedure, we believe we can reduce or eliminate the incidence of haze."

Post-surgical haze occurs in approximately 4% of LASIK patients and about 8% of individuals who undergo PRK.

Thomas Motter, Paradigm's CEO, says he's hopeful that the new medication, called Plasminorene, can be fast-tracked directly from pre-clinical animal studies to Phase III human clinical trials.

"Plasminogen activators have been used before in the human body, so their properties are well understood," says Motter. "We see Plasminorene as the last-leg of a three legged-stool in terms of prophylactic medications used in connection with corneal procedures. We already have antibiotic and anti-inflammatory eye drops. Plasminorene has the potential to play a key role in ensuring a quick and complication-free corneal healing process.

In a recent press release, Motter said Plasminorene has the potential to generfate annual revenues of betweem $500 million and $1 billion for Paradigm.

Recently announced federal regulations mandating strict standards for protecting the privacy of all patient medical records will cost the medical community more than $17 billion to implement -- unless the Bush administration and the new Congress make changes in the rules before they go into effect in February 2003.

In its initial reaction to the more than 1,500 pages of privacy-related regulations released by outgoing Health and Human Services (HHS) Secretary Donna Shalala in late December, the American Society of Cataract and Refractive Surgery (ASCRS) said that while it "agrees that the privacy of medical records is critical, the Society is concerned that these regulations could be very burdensome for physician practices."

The new rules require written patient consent for the use or release of health records, give patients more access to their own records, require that the medical community adopt "privacy-conscious" business practices, and establish civil and criminal penalties for improper disclosures. The regulations apply to all paper and electronic records, as well as oral communications.

Practice management consultants say the rules are so sweeping they will require most practices to designate a staff member as "privacy officer."

The bipartisan Health Insurance Portability and Accountability Act of 1996 (HIPAA) had called on Congress to enact medical records privacy standards by 1999. When Congress failed to meet that deadline, the task fell to HHS. However, groups representing physicians, hospitals, health plans, pharmaceutical companies and medical device manufacturers have all expressed concerns about aspects of the regulations and say they'll lobby Congress and the new HHS leadership to make changes.

One major concern is that the federal rules set "minimum" records privacy standards that can be superseded by even stricter state laws. The Healthcare Leadership Council, a coalition of chief executives representing the healthcare industry, advocates a single national privacy standard.

Icon and Lasik Vision Plan Merger, Price Increase
Icon CEO Drops A Hint.

 When Icon Laser Eye Centers Inc. President Ghassan Barazi recently announced that Icon and Lasik Vision Corporation planned to combine their operations, he had some good news for long-suffering shareholders of both money-losing Canadian companies. He predicted that merging the two "value LASIK" businesses will create opportunities for substantial efficiencies and cost-savings.

Barazi, who will serve as president and CEO of the merged company, went on to say that Icon and Lasik Vision combined perform more procedures a year than any other single competitor.

But Barazi didn't stop there. He also said the combined company would be able to increase revenue by about $US20 million a year by raising its basic procedure price by $100 an eye. Recently, both Icon and Lasik Vision have been advertising basic LASIK prices of around $500 an eye.

Industry analyst Al Kildani of Pacific Growth Equities, Inc. of San Francisco, says Barazi's statement is the first real sign that the cutthroat LASIK competition of the past year may be easing.

Some independent surgeons are reluctant to agree, citing patient confusion over price differences as one reason volume leveled off at the end of 2000.

REFRACTIVE SURGERY UPDATE

Custom ablation. 20/10 Perfect Vision says refractive treatments on nine patients using a combination of the company's WaveScan Wavefront System and the VISX Star 53 ActiveTrak with Variable Spot Scanning resulted in all patients achieving 20/20 or better vision at 1-month follow-up examinations. The patients had refractive errors ranging from -1.75D to -3.75D spherical equivalent.

Complaint settled. Laser Vision Centers, Inc. and four of its executives have agreed to pay a total of $1.5 million to settle an FDA complaint that the company improperly altered software in 1996 to perform laser eye surgery on higher myopia cases than were approved at that time. The FDA did approve the use of excimer lasers for myopia greater than -6.0D in 1998.

New CEOs. Elizabeth H. Davila has been named CEO of VISX, Inc., a leader in the development of refractive laser technology. Davila, formerly the company's presiddent, replaces Mark B. Logan, who will remain as chairman until the annual meeting. Thomas Rogan has become CEO of Clear Vision Laser Centers, Inc., the largest privately held provider of laser vision correction services. Rogan replaces Clear Vision founder Donald Wingerter.

LCA-Vision optimistic. LCA-Vision says it expects to perform about 100,000 laser vision correction procedures this year, up from approximately 59,000 in 2000.

CFOs leave. Peter Kastelic has resigned as chief financial officer of TLC Laser Eye Centers to pursue other opportunities. Mark Fischer-Colbrie relinquished his position as CFO of KeraVision in a recent downsizing.

Record month. Laser Vision Centers, Inc. says January was its best month ever for refractive case volume, with total procedures more than 30% higher than the company's previous record, set last June.

IN THE NEWS

New Visudyne treatments. The FDA has issued an "approvable letter" indicating it will soon approve Visudyne for the treatment of predominantly classic subfoveal choroidal neovascularization (CNV) caused by macular conditions other than age-related macular degeneration (AMD). These conditions include pathologic myopia and ocular histoplasmosis syndrome, among others. Visudyne is already approved for the treatment of CNV caused by AMD.

Occult CNV. Novartis Pharmaceutical and QLT Inc., the co-developers of Visudyne, say results of a recent Phase IIIb clinical trial involving 339 patients indicate that Visudyne therapy is effective in the treatment of AMD-related occult CNV.

Photodynamic therapy. Allergan has signed an agreement with Photochemical Co., Ltd. for the right to develop a light-activated modified porphyrin compound for treatment of AMD. The compound has displayed highly focused tissue selectivity capabilities in pre-clinical testing.

Acquisitions. Laser Vision Centers, Inc. has completed the purchase of O.R. Providers and Southern Ophthalmics, providers of mobile cataract services.

Xalatan sales. Xalatan, the world's top-selling glaucoma medication, recorded sales of $693 million in 2000, a 37% increase over the previous year, according to Pharmacia Corp., the drug's manufacturer.

Diabetic retinopathy. Keryx Biopharmaceuticals has received a U.S. patent for the use of sulodexide (KRX-101) in the treatment of diabetic retinopathy. The company says preliminary studies indicate that sulodexide is effective in treating the lesions that are a primary characteristic of diabetic retinopathy.

Diagnostic workstation. LaserSight Inc. has received FDA approval to market its AstraMax diagnostic workstation. The integrated refractive workstation provides a range of precise eye measurements that can be used in a variety of ophthalmic applications.

Inspire trial. Inspire Pharmaceuticals has filed an investigational new drug application for a treatment for retinal detachment and retinal edema. The company plans to initiate a Phase I/II trial for its INS37217 Ophthalmic P2Y2 receptor agonist, which is intended to facilitate retinal reattachment without the need for surgery.

Dispensing Web site. Essilor of America, Inc. has launched VariluxMD.com, an online resource whose purpose is to provide ophthalmologists with timely, practical knowledge on a wide variety of topics related to optical dispensing management.

Menicon agreement. Menicon Co., Ltd. has transferred the manufacture and distribution of Menicon Z and Menicon SF-P rigid gas permeable (RGP) contact lenses from Menicon USA to Con-Cise Contact Lens Co. of San Leandro, Calif. The agreement, which affects only the U.S. market, is expected to expand Menicon's RGP contact lens business in the United States.

Lawsuit filed. Ocular Sciences has filed an action against Weblens.net, charging the contact lens e-tailer with obtaining Ocular's contact lenses in violation of Ocular's long-standing policy of selling its lenses only to authorized distributors and eyecare practioners.

Executive resigns. Hakan Edstrom has resigned as head of Bausch & Lomb's Americas Region.

Reed dies. John Franklin Reed, 83, a member of the board of directors and executive committee of Rhein Medical, died on Jan. 19. Reed had been associated with the company since its inception.

STAAR director. John R. Gilbert, a retired Johnson & Johnson executive, has been appointed to the STAAR Surgical Company board of directors.