Practice Pulse
Tips, Trends, & News You Can Use

DOGS' EYE VIEW
Vision Research on Man's Best Friend Offers Future Hope

The genetic disorder Leber Congenital Amaurosis (LCA) is one of the several incurable forms of blindness collectively known as retinitis pigmentosa. LCA occurs when there is a defect in any of several genes that help convert light into electrical signals in the eye. The condition affects children who inherit two defective copies -- one from each parent.

Now there's hope, albeit in the distant future for individuals suffering from LCA. Researchers at the Scheie Institute's F.M. Kirby Center for Molecular Ophthalmology at the University of Pennsylvania have recently reversed congenital blindness in Briard dogs, which in the course of long-term breeding by humans, have acquired a blinding genetic mutation in the RPE65 gene -- identical to the one that causes about 20 % of LCA cases. Mutations in any of a dozen or so other genes also cause LCA, and mutations in others cause other forms of retinitis pigmentosa.

Researchers injected thousands of copies of a virus directly into the eyes of three blind Briards (Lancelot, Guenevere and Arthur), who were between the ages of 2 and 4 months old. The virus, Adeno-Associated Virus (AAV), was genetically engineered by scientists at the University of Florida and contain healthy versions of the RPE65 gene. The dogs' right eyes received injections of the viruses directly behind the retina, close to the retinal pigment epithelial cells where the RPE65 gene does its job. Before long, all three dogs had vision in their right eyes.

The dogs will receive non-invasive tests of visual function at designated time intervals after treatment to obtain quantitative information on the persistence of the therapeutic effect. Researcher Jean Bennett says that at a distant point in the future, they may treat their contralateral eyes to see whether we can restore vision to them as well. All three dogs are still seeing well 9 months after treatment, with no ill effects. On another happy note, Guenevere is now the proud new mother of a litter of puppies.

"If the technique proves safe and effective," Bennett said, "it may also work for other kinds of retinitis pigmentosa using viruses stuffed with the appropriate genes." And, according to the researchers, if ongoing studies in dogs go well, the first human studies could begin in the next 3 to 4 years.

INCREASED PRESCRIPTION SPENDING
Why This Trend Is Occurring

Have you noticed that the low grumbles from your patients about the cost of prescription drugs has escalated to a growl? If so, you're not alone. According to a study issued by the National Institute for Health Care Management Foundation, spending on prescription drugs shot up 18.8% last year to $131.9 billion. The study is based on data from Scott-Levin Inc., a healthcare market research company.

The following are the three factors the report identifies as contributors to the increase in retail spending on prescription drugs last year:

1. 42% of spending was attributable to an increase in the number of prescriptions written by doctors and filled by pharmacies

2. 36% of the increase in spending was attributable to the use of more expensive drugs

3. price increases accounted for 22% of the increase.

These figures don't include mail-order sales, but the report states that mail-order sales of prescription drugs totaled $16 billion last year, up 26% from $12.7 billion in 1999.

Other factors are the aggressive marketing campaigns for prescription drugs and also better insurance coverage for drugs offered by employers. So, although there's nothing you can do to change this trend, you can talk to your patients when you hear that grumble getting louder. Explain the notion of supply and demand and offer them less expensive medications or treatments.

ANTITRUST LAWSUIT SETTLED
AOA, J & J Agree On Terms.

The American Optometric Association (AOA) has settled the antitrust lawsuit attorneys general in 32 states filed against it 6 years ago.

As you may recall, the state of Florida alleged collusion between the AOA and contact lens manufacturers so that the manufacturers wouldn't sell lenses to mail order houses and other alternate supply sources. Other states then joined this suit, adding an allegation that the defendants conspired to withhold prescriptions from consumers.

Though it hasn't admitted guilt, the AOA will pay $750,000 into a fund to which co-defendants CIBA Vision and Bausch & Lomb have already contributed, and refrain from asking contact lens companies not to sell to distributors and from any other activities that could be considered restraint of trade. The money will pay for attorney fees and other costs, and the balance will be distributed by order of court.

Vistakon (a division of Johnson & Johnson), another defendant in the suit, announced that Johnson & Johnson will pay $60 million to settle the lawsuit.

Johnson and Johnson may provide as much as $100 in discounts for future purchases of contact lenses and eye exams and will also increase the availability of replacement lenses at pharmacies, by mail order and on the Internet.

Philip Keefer, president of Vistakon, Americas, notes, "Our settlement is significantly different from those of the other defendants because we don't have to unconditionally give in to mail order houses. Attorneys general must enforce the laws in their states, which means that they will in fact partner with us." Vistakon will sell its ACUVUE contact lenses to mail order provided that the houses sell contact lenses only to consumers; only with a valid prescription and; according to state and federal regulations. The houses also must not sell Vistakon's diagnostic lenses to consumers.

Johnson & Johnson is the final defendant to settle the suit.

A DOWNWARD TREND IN REFRACTIVE SURGERY?
Not for everyone, and not for long.
BY TERRI B. GOSHKO, Associate Editor

According to a recent issue of The Wall Street Journal, growth in the laser eye surgery market "has come to a screeching halt after 5 giddy years of expansion." Concerns about side effects and efficacy, coupled with a slowing economy and a proliferation of laser surgery centers, are to blame, they say.

MarketScope, a research firm based in St. Louis, agrees, saying that the number of laser assisted in-situ keratomileusis (LASIK) procedures increased by only 50.3% in 2000 after doubling for each of the preceding 3 years. Growth fell from 14.8% in the second quarter of 2000 to 3.9% in the third quarter to almost nothing in the fourth quarter.

The experience of some refractive surgery comanaging O.D.s OM spoke with affirmed this trend.

"We've heard from some patients who consider LASIK a luxury item," says Paul Ajamian, O.D. "With the stock market dropping and less money available, the growth has perhaps slowed somewhat."

Ed Wasloski, O.D., cites competition as a major factor in the growth slowdown. "A number of low-cost laser centers opened in the Baltimore area last year," he noted, "so our growth leveled off in 2000."

Not everyone noticed a slowdown, however, and most are optimistic. Dr. Wasloski notes, "In January and February of 2001, we've begun to see growth."

"I don't think we've seen any real change in the number of LASIK cases," says Dennis Mathews, O.D. "But I think you can expect that LASIK will be like an elective plastic surgery procedure. When money's available, it'll be a hotter procedure than when money's tight."

Jeffrey Augustine, O.D., president of the Optometric Refractive Surgery Society, doesn't see a drop in the growth of refractive surgery overall, or an effect of the national economy. "More expensive centers draw fewer patients than less expensive ones, regardless of the state of the economy," he says. "Patients are savvier because they can get information from sources like the Internet. They know what's out there and they want to get the best price for the most technology from the best surgeon. Refractive surgery is healthy. What we have to guard against is the growth of a la carte procedures in which every element costs extra."

Brian Den Beste, O.D., believes that quality of care and setting your practice apart from others by using technology can keep you busy despite increased competition. "We haven't noticed a slow-down in our center, and I think it's because we teach, and adopt new technology."

People across the country have mentioned an overall downward trend to Paul Karpecki, O.D., but he hasn't been personally affected. "In fact, we're sequentially up each quarter, including the current, but I think we're seeing a flattening of the trend line indicating slower growth," he says. "The economic slowdown and also extreme weather in my area, the Midwest, may have caused the downward trend for most practices. Discount centers don't seem to compete with our practice because we serve a different population."

Jim Thimons, O.D., has also seen his practice grow in the past year. "Because of recent negative press about refractive surgery, patients are being much more selective and are choosing quality over discount providers," he analyzes. " I attribute our growth to our excellent relationships with referral doctors and our commitment to providing a level of excellence in our services."

Confusion over price (wildly differing discounts) and the economic slowdown were responsible for the drop in growth in 2000, says Irving Arons of Spectrum Consulting in Peabody, Mass., but he also sees smoother sailing ahead.

"Companies like TLC that have reported first quarter figures for 2001 say they're up by 15% to 20%," he points out. "Refractive surgery's good and people like it. Word of mouth will spread and there's reason to hope growth will be back to 50% by the year's end."

SOLUTION INSTRUCTIONS
What Do Those Labels Mean, Anyway?

Though some practitioners think of them as mere marketing gimmicks, special contact lens solution labeling means that the products have passed FDA cleaning efficacy tests. Here's a run-down of solutions and labeling.

Multi-purpose solutions (MPS). Solutions that are permitted to use this label are Bausch & Lomb's ReNu, CIBA Vision's SoloCare and Alcon's Opti-One.

The multi-purpose designation indicates that during soaking, these solutions killed one log unit each of three test bacteria and five logs among the three. They also showed no growth of two test fungi during the soak time and good efficacy when all test steps (rub, rinse and soak) were followed.

Multi-purpose disinfecting solutions (MPDSs). Opti-Free Express (Alcon) and ReNu Multi-Plus (B&L) kill without rub or rinse in vitro and are more effective than MPSs in soaking-only tests. They kill at least three logs of each of three test bacteria and one log each of two test fungi during their labeled soak times without rub or rinse.

No-rub solutions. No-Rub Opti-Free Express MPDS, Allergan's Complete and CIBA Vision's AO Sept Clear Care demonstrate microbiological cleaning without rubbing.

They achieved MPDS labeling in stand-alone tests, killed five logs each of five test organisms with rinse-and-soak only and worked even when lenses were artificially soiled. No-Rub Opti-Free Express MPDS can be used for all wearing schedules; Complete and AO Sept Clear Care can be used for lenses worn up to 30 days.

(For more on solutions, see the "Contact Lens Solutions and Lens Care Update" in the June issue of Contact Lens Spectrum.)

AOA HOUSE OF DELEGATES
Board Certification Revisited

If you'll attend this year's annual American Optometric Association (AOA) meeting in Boston, you might want to check into what's happening with board certification -- or as the topic is now being referred to -- continued competency.

A report on continued competen-cy will be presented during the house of delegates. At press time, the AOA didn't have a specific times yet.

However, the house of delegates sessions will be held as follows:

• Thursday: 10 a.m. to 12 p.m. & 1:30 p.m. to 3:45 p.m.
• Friday: 9 a.m. to 12 p.m.
• Saturday: 9 a.m. to 11:30 a.m. & 1:30 to 4:30 p.m.

NEW APPROVALS

Aspheric Contact Lens with Direct Delivery

CooperVision introduced its new planned replacement aspheric lens, Ascend, for spherical lens wearers and those with low amounts of astigmatism. The lens will be available only to practitioners and will be directly delivered to patients. By offering the lens only to practitioners, CooperVision hopes to eliminate the potential for gray market diversion. The lens is made of methafilcon A, which is 55% water and has a monthly replacement schedule.

Drug for CMV Retinitis

Valganciclovir (Valcyte), an oral drug indicated for treating cytomegalovirus (CMV) retinitis in AIDS patients, was recently approved. The drug's manufact-urer, Hoffmann-La Roche, expects Valcyte to replace the most widely prescribed anti-CMV medication, ganciclovir (Cytovene), which is also manufactured by Roche but is an intravenous drug. Valcyte offers comparable efficacy to Cytovene but with a much more convenient dosing regimen, reports Hoffman-La Roche.

Lens for Astigmatic Presbyopes

Blanchard Contact Lens, Inc., recently received FDA market clearance and launched its new ESSential Soft Toric Multifocal lens. The lens has already demonstrated benefits for astigmatic presbyopes, according to the manufacturer.

The lens is manufactured in hioxifilcon B. It features base curves of 8.8 mm, 8.4 mm and 8.2 mm with diameters of 14.8 mm, 14.5 mm and 14.0 mm, respectively. Cylinder correction ranges from -0.75D to -3.00D, spherical correction from -8.50D to +6.50D and add corrections up to +2.75D.

Laser Approved for Trabeculoplasties

Coherent recently received approval from the FDA to market its Selecta 7000 Glaucoma Laser System. Designed to perform selective laser trabeculoplasty (SLT), the laser uses a patented new technique for treating open-angle glaucoma. According to the company, SLT is less traumatic to the eye than the current laser procedure used to treat glaucoma -- argon laser trabeculoplasty.

O.D. NOTEBOOK
 PEOPLE AND PROMOTIONS

Stereo Optical president retires. Joseph Andera, president of Stereo Optical for the past 2 decades, has retired. Mr. Andera officially relinquished the company helm to Thomas Judy on March 31, 2001. As General Manager, Mr. Judy will now lead Stereo Optical, which is a division of Gerber Coburn.

VCA to present award to low vision expert. Vision Council of America (VCA) and Association Expositions & Services will present the 2nd Annual Jake Rosner Award to Dr. Alfred Rosenbloom, founder and current chair of the Chicago Lighthouse Low Vision Clinics, at Eyequest 2001 in Rosemont, Ill. VCA is also donating a piece of equipment to Dr. Rosenbloom's alma mater, The Illinois College of Optometry.

Rodenstock names new director of marketing. John Potocny, vice president and general manager of Rodenstock North America Frames Division announced that Adelle Erdman will become the director of marketing effective immediately.

Ophthalmic genetics expert to head NEI. The National Institutes of Health has named Paul A. Sieving, M.D., Ph.D., as director of the National Eye Institute (NEI). Dr. Sieving is the Paul R. Lichter Professor of Ophthalmic Genetics and director, Center for Retinal and Macular Degeneration, at the Department of Ophthalmology and Visual Sciences, University of Michigan Kellogg Eye Center, Ann Arbor. He will join the NEI in late spring.

New board members announced. Prevent Blindness America announced the appointment of three new board members at its recent annual meeting. Joining as members of the Class of 2003 are Anthony J. Adams, O.D., Ph.D., dean of the University of California, Berkeley School of Optometry; the Honorable Patrick J. Tiberi, U.S. House of Representatives; and R. Rick Hart of Nashville, who joins the board for a 1-year term.

Top sale staffers named. Signet Armorlite, Inc. recently held its National Sales Meeting, which concluded with an awards ceremony. Glenn Batteiger (Southeastern Region) was named Sales Rep of the Year, and his team, including Greg Heintz, Kim Chappell, Judee Davis and Sam Walker, earned Sales Team of the Year honors. Another sales team (based in Texas) including Mike Brown, Rene Molina and Janine Ybarra received an award for highest annual Kodak Lens sales. Glenn Batteiger and Rick Mider (Mid-Atlantic) received awards for their territories' highest annual SunSensors Lens sales. Dave Reed, eastern regional manager, accepted the award for Sales Region of the Year.

COMPANY NEWS

Negotiations to merge Pro-Laser and Briot International are underway. Buchmann Optical Holding N.V. (BOH), a Belgian holding company, has signed a Letter of Intent with the purpose to acquire the majority of the shares of Pro-Laser Ltd. According to the letter, BOH will become Pro-Laser's majority shareholder and in return will contribute 51% of the shares of Briot International and invest an additional sum of EURO $2.5 million. BOH will also assume responsibility for the management of Pro-Laser.

The two parties agreed to conduct necessary due diligence procedures and enter negotiations to reach a final agreement no later than June 30, 2001.

Vision benefit maintained during Visudyne therapy. Research sponsored by Novartis AG was presented at the annual Association for Research in Vision and Ophthalmology (ARVO) conference. The data showed that average visual acuity remained stable during the third year of verteporfin (Visudyne) therapy in patients who have age-related macular degeneration (AMD). The results are based on an extension of the pivotal Phase III clinical trial called the TAP (Treatment of AMD in Photodynamic therapy) Investigation, which is a 2-year randomized, double-masked, placebo- controlled trial. Following the conclusion of the trial, 78% of the original 609 patients in the TAP Investigation were offered Visudyne therapy in an ongoing open-label extension trial regardless of whether they previously received Visudyne or a placebo in the original study.

During the third year of treatment, patients received an average of 1.4 treatments, a decrease from the 3.4 and 2.1 treatments received in the first and second year, respectively.

CIBA Vision expansion. CIBA Vision is adding jobs and expanding its facilities in Puerto Rico and Canada. In Cidra, Puerto Rico, CIBA Vision will add approximately 150 new jobs and enhance its contact lens manufacturing site by adding 10,000 square feet and remodeling 25,000 square feet of space.

In Mississauga, Canada, the former Wesley Jessen customer service and distribution facilities are being integrated into CIBA Vision's facility in the same city. An addition of 18,000 square feet will be added to CIBA Vision's existing facility. The company is also hiring and training 80 additional customer service representatives at this location.

Gerber Coburn to stay with parent company. Gerber Scientific, Inc. today reported that it has completed its previously announced review of strategic alternatives for its optical lens processing unit, Gerber Coburn. Based on this review, Gerber Scientific Inc. has determined that Gerber Coburn will remain a business segment of the company.

Invicta and AccuRx enter into strategic partnership. Invicta Corporation and AccuRx announce partnership for distribution of the Solera photochromic lens in the Northeast. Invicta will send a Solera representative, along with the latest point-of-sale materials, display materials and high intensity Solera graphics to the American Optometric Association's 104th Congress in Boston this month.

Pulse Data International acquisitions. Pulse Data International Ltd., the New Zealand-based maker of technology for the visually impaired, recently announced its intention to acquire 100% of the shares of HumanWare Inc. from HumanWare's Dutch parent company, Tieman Group. The acquisition occurred last month. HumanWare Inc. is also a full-service provider of technology for the visually impaired.

Pulse Data has also acquired a major stake in AccessAbility Inc., a distributor of products for the blind and visually impaired.

Welch Allyn vision screener wins award. Welch Allyn, Inc.'s SureSight vision screener recently won the Design News "Excellence in Design" Award. The SureSight is a hand-held, child-friendly device that offers physicians a means to easily detect common vision disorders affecting young children. This is the third engineering excellence award the SureSight has received.

ODC and Signet partner up. Optical Dynamics Corporation (ODC) announced a licensing agreement with Signet Armorlite. Together, the two companies plan to explore and develop market expansion opportunities. Under the terms of the agreement, ODC will receive a license to Signet Armorlite's in-mold coating patents and Signet will assist ODC in mold development and lens designs.

EyeSys product line bought. Tracey Technologies, with support from Marco Ophthalmic, signed a letter of agreement to purchase the EyeSys product line (including a corneal topography system) from Premier Laser Systems.

Novartis offers free, web-based Internet service to managed care organizations. Novartis Ophthalmics, Inc. now provides a Web-based Internet service to help managed care organizations offer healthcare providers and their patients with important information about eye diseases and their treatments quickly and easily.

The company demonstrated OphthaInsight.com two months ago, at the Academy of Managed Care Pharmacy meeting in Tampa. You'll need a password to access the pre-written educational and promotional materials including formulary announcement letters and patient-education brochures. The Web site provides information about the formulary status and benefits of Novartis products as well as guidance on other pharmaceutical products.

Airwear range extended. Essilor Lenses, the Lens Division of Essilor of America, Inc., has extended the range of the company's finished single-vision (FSV) Airwear lens products to include +4.00 to 8.00, to -2.00 cylinder.

Art Optical reaches 70-year milestone. Art Optical Contact Lens, Inc. announces that 2001 marks their 70th year of service to the ophthalmic professions. The company has been awarded the Contact Lens Manufacturers Association "Seal of Excellence Manufacturing Award" each year since its inception.