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Peli Offers Hope for Low-Vision Drivers
Putting the Visually Impaired on the Road, Safely.

Eli Peli, O.D., a low-vision clinician for 20 years who heads a large research team at the Schepens Eye Institute, Harvard Medical School, is leading a quiet crusade. Dr. Peli believes that visually impaired persons who desire to drive should be evaluated on an individual basis, and not be subject to widely varying state laws that often deny driving privileges to people simply because they have a specific condition.

"In 27 states, if you have hemianopia, a loss of visual field almost always resulting from a stroke, you're prohibited from driving," says Dr. Peli. "Yet, there are tens of thousands of hemianopes in these states who are capable of passing a driving test and operating a vehicle safely. They should first be evaluated by a neuro-ophthalmologist or a low-vision specialist who has expertise in assessing their condition and, if the specialist approves, they should be given the opportunity to take a road test. In Holland and Belgium, these patients get such an evaluation."

But Dr. Peli is more than just an advocate. His team is currently developing technology that will help put more low-vision individuals in the driver's seat. One example: a prism that's embedded in the eyeglasses of a hemianope to widen the person's visual field. Another: an in-the-lens bioptic telescope that simultaneously provides both high resolution and a wider field of view (bioptic telescopes can be used by drivers in 34 states).

"We've already had several hemianopes who obtained driving privileges with the help of our prism lenses," notes Dr. Peli.

Recently, Dr. Peli and his brother, Doron, a professional writer, authored a book, Driving with Confidence: A Practical Guide to Driving with Low Vision. The book is intended as a comprehensive primer -- covering each state's current driver-licensing regulations, the availability and effectiveness of low-vision driving aids, and recommendations that would expand at least some driving privileges to a greater number of low-vision individuals.

"Of course, some people just shouldn't be driving at all, and to those we offer some alternatives, as well," says Dr Peli.

Ophthalmologists who read the book, which can be ordered through the World Scientific Publishing Company Web site at http://www.wspc.com/or through Amazon.com for about $18, can use it as a resource to enable them to make more informed recommendations to their patients concerning the legal, medical and technological aspects of driving (or not driving) with visual impairments. The book is in large print so that visually impaired patients can read it easily.

"When you take away someone's mobility, you take away a lot," says Dr. Peli. "Some people just need to drive a few blocks to the supermarket during the daytime, and we should give them every opportunity to earn a restricted license if they show they can make the trip safely."

Eyecare Stocks Stage a Rebound
New Technology Sparks Rally.

Spurred largely by the launch of custom ablation in the United States and the anticipated approval of phakic IOLs in the near future, many eyecare stocks have been star performers in this year's stock market rally. The strong gains have come after almost 3 years of dismal performance by most stock groups.

Not all eyecare stocks have participated equally in the advance. (See Stock Watch table on page 12.) Some companies closely identified with custom ablation or phakic IOLs have chalked up especially healthy percentage gains. For example, VISX, which makes the CustomVue laser system for custom ablation, saw its stock more than double in the period between the beginning of the year and mid-August. STAAR Surgical, which expects its Implantable Contact Lens (ICL) to be the first phakic IOL to receive FDA approval, saw its stock more than triple during the same time period.

Even larger percentage gains were achieved by the stocks of two companies that operate laser vision correction centers. Both LCA-Vision and TLC Vision expect to see both procedure volume and fees rise as their surgeons perform a growing number of higher-priced custom treatments. The stocks of these two companies increased about fivefold from the start of the year to mid-August.

Among the larger, more diversified eyecare companies, Alcon shares continued to make new highs this year as the company exceeded earnings and revenue targets each quarter. Alcon has also recently launched a large number of new products that have captured the attention of eyecare practitioners, including the LADARVision system for custom ablation. American Medical Optics' shares have also been solid performers, with the company's stock tracking higher as the year progressed and earnings grew. Bausch & Lomb saw its stock move up several points in mid-summer on the strength of improved earnings and a brighter future outlook.

Other eyecare-related stocks have also participated in this year's rally. The stock of QLT Inc., the co-developer of Visudyne for the treatment of wet AMD, has been a good percentage gainer in 2003 as earnings have surpassed analysts estimates. Inspire Pharmaceuticals, which is partnering with Allergan on several treatments for dry eye, is also up solidly since the start of the year.

In fact, in the entire eyecare realm, it's difficult to find a company outside of the so-called "penny stock" category whose stock has had a bad year.

REFRACTIVE SURGERY UPDATE

IntraLase use increases. IntraLase Corp., developer of a proprietary femtosecond laser that replaces the microkeratome, said it placed 22 of its lasers in the second quarter of 2003, marking the company's strongest quarter since the commercialization of the IntraLase FS laser early last year. IntraLase has now placed a total of 64 lasers with refractive surgery practices.

The industry research organization MarketScope estimates that the IntraLase FS laser was used in 7% of all U.S. vision correction surgeries in the second quarter of this year, up from an estimated 5% of surgeries in the first 3 months of the year.

B&L licenses IOL technology. Bausch & Lomb will partner in the development of a new, proprietary accommodative IOL technology. The company has entered into a licensing agreement with Faezeh Mona Sarfarazi, M.D., inventor of a single-piece, molded silicone lens with a dual-optic design. Dr. Sarfarazi is president of Shenasa Medical LLC and Shenasa Inc.

The FDA Ophthalmic Devices Panel recently voted to give its first "approvable" recommendation to an accommodative IOL. The panel unanimously approved the CrystaLens, developed by C&C Vision.

Acquired. CareCredit, a leading provider of patient payment programs, has acquired Health Capital Patient Financing. The operations of the two companies will be combined, with Health Capital Patient Financing becoming part of CareCredit.

Correction

Outdated information about the Laser Diagnostic Technologies GDx VCC was printed in the Retinal Scanners section of the Diagnostic Instrument Buying Guide, which was distributed with the July issue of Ophthalmology Management. Here is the listing as it should have appeared.

Company: Laser Diagnostic Technologies

Model: GDx VCC (Variable Corneal Compensator)

Price: $38,950

Warranty: 1 year

Type of Laser: Scanning laser polarimeter

Filed of View: 20 degrees x 20 degrees

Area of Retina Analyzed: Peripapillary retinal nerve fiber layer

Printout Detail: Simplified parameters; deviation from normal and serial analysis

Additional Features: Variable Corneal Compensation isolates RNFL; <4 micron reproducibility and 802-eye database provide superior sensitivity.

Physician Fee Schedule Is a Mixed Bag
Across-the-Board Cuts Somewhat Offset By Key Increases.

As generally predicted, the preliminary 2004 Medicare Physician Fee Schedule holds some bad news for ophthalmologists in the form of a 4.2% across-the-board reduction in physician payments, and another approximately 0.5% downward revision for eye M.D.s due to refinements in calculating practice expense relative value units.

However, the unexpected good news is that the new fee schedule provides modest physician payment increases in such key procedures as basic cataract surgery, YAG laser capsulotomy and eye exams for established patients.

"Our goal now is to obtain the same kind of legislative relief we were able to get this year and have these across-the-board cuts reversed," said Catherine Cohen, American Academy of Ophthalmology Vice President for Governmental Affairs. "If we can achieve that, we'll have some nice increases in some of ophthalmology's most high-volume codes."

Cohen said that it's now important for physicians to mobilize and oppose the cuts.

The Centers for Medicare and Medicaid Services will accept comments on the 2004 fee schedule until Oct. 7. The final fee schedule will be released in early November.

IN THE NEWS

Once-a-day timolol. ISTA Pharmaceuticals said the FDA has issued an approvable letter for Istalol, a once-a-day liquid formulation of timolol for treating glaucoma. The company said it can readily address manufacturing issues cited by the FDA and believes the product remains on track for approval and launch early next year.

In clinical trials, the new formulation demonstrated comparable efficacy and safety to timolol maleate ophthalmic solution, commonly applied b.i.d.

Dry eye drug. Inspire Pharmaceuticals said the FDA has granted priority review status to the company's New Drug Application (NDA) for diquafosol tetrasodium ophthalmic solution for dry eye.

Inspire, which is partnering with Allergan on dry eye treatments, said accelerated review of the NDA creates the potential for a product launch early next year.

Changing hands. Alcon Inc.'s subsidiary in Spain has agreed to sell its contact lens care solutions manufacturing facility in Madrid, Spain, to the Spanish subsidiary of Advanced Medical Optics for approximately $22 million. The sale is expected to close in November.

Alcon said production of contact lens care products formerly manufactured in Madrid will be transferred to other Alcon facilities.

For sale. Pfizer is exploring the sale of the surgical ophthalmology business it acquired through its recent purchase of Pharmacia. This business, which recorded revenues of about $150 million last year, includes the Healon line of viscoelastic products, and CeeOn and Tecnis IOLs.

Pfizer CEO Hank McKinnell said the surgical ophthalmology business lies outside the company's three core areas of strategic focus -- pharmaceuticals, consumer health care and animal health.

WhiteStar study. In a recent study involving 10 cataract surgery patients, surgeons using WhiteStar technology were able to safely perform bimanual phacoemulsification without an irrigation sleeve through a 1.2mm incision. The study's authors, led by Eric Donnenfeld, M.D., concluded that the decreased thermal effects with WhiteStar technology make an irrigation sleeve over the needle unnecessary because extensive cooling of the needle during extraction isn't needed.

Scope of practice. For the fourth consecutive year, the Alaska State Ophthalmological Society and the American Academy of Ophthalmology joined forces to defeat an attempt by the optometry lobby to expand optometrists' scope of practice in Alaska. Proposed legislation that would have allowed O.D.s to prescribe oral drugs and controlled substances, and perform injections, was killed in state House and Senate committees.

HIPAA reminder. The deadline for all medical practices to comply with HIPAA standards regarding electronic transactions is Oct. 16, 2003. This includes practices that received 1-year extensions last year. However, the Centers for Medicare and Medicaid Services has indicated that enforcement will be "complaint driven" and that practices won't be penalized if they take prompt corrective action to comply with the new electronic transaction standards.