Article Date: 12/1/2005

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Decorative Lenses are Now Regulated

President Bush last month signed into law S. 172, or The Contact Lens Regulation Act, a bill that amends the Federal Food, Drug and Cosmetic Act to protect patients from eye injuries due to the misuse of decorative plano contact lenses. These lenses are now again regulated by the FDA as medical devices and consumers must obtain a prescription from a licensed eyecare professional to purchase them. The House of Representatives approved the bill in November.

In other legislative news, Congress took steps to strengthen anti-counterfeiting laws last month, passing the Stop Counterfeiting in Manufactured Goods Act in both houses. While the eyecare industry is a small part of this overall issue, counterfeiting has been a long-standing problem in the industry, explains Eve Zartman-Ball, manager of government relations and advocacy at VCA. Moreover, it's a threat to consumers — counterfeit goods are not medically and safety tested, Ms. Zartman-Ball points out. For instance, "knock-off" sunglass lenses are not tested with the FDA, and so may not provide ultra-violet protection.

The counterfeiting bill is expected to be signed into law by President Bush in the coming weeks.

1-800 Blames Loss on Regulation

OM on the Web
A Corneal Reshaping Update
Web Site Exclusive
From newly-marketed lenses to those awaiting FDA approval, Barbara Anan Kogan, O.D., discusses the latest offerings from the companies that manufacture corneal reshaping contact lenses. Included is a report on corneal reshaping from the FDA's perspective.

Shares for the online contact lens discounter 1-800 Contacts fell in the third quarter for a net loss of $0.6 million, or $0.04 per diluted common share. For the year-ago quarter, the company reported a net income of $1.4 million, or $0.10 per diluted common share. According to Chief Executive Officer Jonathan Coon, a major reason for the  loss is "the growing problem of 'doctors' only' lenses."

The company believed that language in the recently-passed appropriations bill, H.R. 2744, titled, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2006 to require contact lens manufacturers to sell lenses through all sales channels. However, that provision was not included in the final version of the bill Congress passed in October.

"We are currently turning away thousands of customers each week who want to order lenses we cannot obtain," Coon said. 1-800 said that addressing the "threat" of doctors-only lenses will be a top priority.

The company also attributed their third-quarter results to the prescription verification practices of a leading online seller, claiming that Coastal Contacts shows a "pattern of ... non-compliance."

Think Small

By Bob Levoy, O.D.

EYE site
Online Glaucoma Journal
he Optometric Glaucoma Society (OGS) announced that it will publish an electronic journal that covers issues related to glaucoma. Optometrists can receive the journal free of charge by registering at the OGS Web site (

At one time, the mass market was every O.D.'s target population. However, today's best strategy is "niche marketing." This means targeting a specific population of patients, identifying their needs, and then addressing those needs more competently than anyone else.

Enterprise Rent-A-Car is a well-documented example of this strategy. Instead of competing for the highly lucrative frequent-traveler (main stream) car renter, Enterprise caters to the occasional renter — the infrequent renter. Usually, this is someone in need of a car for a few days while his or her car is being repaired. This is a person who is not likely to want to travel out to a Hertz or Avis airport location to rent a car for a few days' use.

The single most significant characteristic of Enterprise Rent-A-Car's strategy has to do with its choice of customers. Everything else flows from this decision. The infrequent renter typically has a unique set of needs that aren't well met by the competition. These are the needs Enterprise has chosen to meet, and they are meeting them better than their competitors can. (Enterprise Rent-A-Car has nearly $7 billion in revenues).

Action step: Give some thought to the type(s) of patients on whom you might focus — exclusively or otherwise. How about Corneal Refractive Therapy (CRT) patients? Sports enthusiasts? Patients with ocular allergies? Or perhaps other types of patients with special needs that are not being met by other optometric practices?

If you're the only practice in town, you can be all things to all people. But if you're in an urban area or in a community with more than two or three other optometric practices, consider the many benefits of setting yourself apart.

Optometrist Will Lead International Research Society

New GP material
Lagado received FDA marketing approval for TYRO-97 (hofocon A), a hydrophilic surface GP contact lens material. It is a fluoro-silicone-acrylate GP lens. The approval includes spherical, aspheric, toric and bifocal contact lenses for daily wear.

Thomas F. Freddo, O.D., Ph.D., F.A.A.O., was recently elected to become the next president of the International Society for Eye Research (ISER). The Society (  was founded in 1968 to establish an international organization to support eye and vision research. It is comprised of vision research scientists from more than 34 countries, and includes national chapters in China, Japan, Israel, and Russia. ISER's official journal is Experimental Eye Research.

Dr. Freddo serves as professor and vice-chairman for Research in the Department of Ophthalmology at Boston University School of Medicine. He practices on the clinical staff of the Boston Medical Center Hospitals. Dr. Freddo serves as adjunct professor of optometry at the New England College of Optometry and is a member of the Board of Directors of The American Academy of Optometry.

Type 2 Diabetes no longer called "Adult Onset"

Barbara Anan Kogan, O.D.

Once affecting only adults, type 2 diabetes now accounts for 8-45% of new childhood diabetes cases (depending on geography and cultural heritage). "Of the more than 20% of new diabetes cases in kids, many in their late teens have complications," says Francine R. Kaufman, M.D., Los Angeles Children's Hospital Director, and chair of the National Institutes of Health's (NIH) National Institute of Diabetes and Digestive Kidney Diseases study, Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY).

Dr. Kaufman cites the NIH's alarming statistic that one in six overweight adolescents is at risk for type 2 diabetes. She also reports that at the Children's Hospital in Los Angeles' Diabetes Center, 25% of the diabetic children treated have type 2 diabetes, compared with 4% a decade ago. This prevalence, seen in approximately two million U.S. children ages 12-19, stems from abnormally high blood sugar levels after not eating for several hours, causing "impaired fasting glucose."

The number of people with type 2 diabetes rose from 18.2 to 21 million in just two years and now afflicts 7% of the U.S. population. The Centers for Disease Control estimates that rate may greatly increase due to the now estimated type 2 acquisition risk of 41 million pre-diabetics. Optometrists can look for risk factors for diabetes, such as obesity, and educate patients about the risks before they're confronted with troubling signs at the fundus.   

To learn more about type 2 diabetes and pre-diabetes in your younger patients, including patient/parent information, go to: the National Diabetes Education Program and the NIH's National Eye Institute's Health Education Program at

To learn more about impaired fasting glucose occurrence of type 2 diabetes in youths, go to these sources: and type in "impaired fasting glucose prevalence, adolescents."
■ An article in the November, 2005 issue of the journal Pediatrics (the official journal of the American Academy of Pediatrics), "Prevalence of Impaired Fasting Glucose and Its Relationship with Cardiovascular Disease Factors in U.S. Adolescents, 1999-2000," can be found at

EYE site

Keep Your Patients from CL Outlets
LENSCO's new patient Web portal,, allows its network of eye care professionals (ECP) to register their patients for convenient replacement service of contact lenses. The service enables LENSCO, "to partner with our ECP network to capture patient revenue that may be lost to mail-order and other big-box outlets," company president Kevin Lippert said. ECPs can establish individual patient accounts, upload patient prescription information, set pricing and provide their patients with secure, password-protected access. The patient can then access their account and have lenses shipped directly to any location.

Acuvue launches TV outreach
Vistakon started a new national television campaign for its Acuvue Oasys with Hydraclear Plus contact lenses. The ad depicts the lens as a breakthrough for contact lens wearers whose eyes feel tired and dry in conditions such as long hours of computer use, frequent air travel, or everyday exposure to heated or air conditioned surroundings. You can also see the ad on and

Send Your Case Studies for REAL

Optos Inc. is asking for "real-life" Optomap Retinal Exam case studies in which the use of the device has made a difference in clinical diagnosis of a patient for its new Retinal Exam Advanced Learning Program. Doctors can submit materials to the program for analysis and discussion on the Optos Web site and in monthly "webinars." One winner and five runners-up will be highlighted each month in the interactive learning format. To submit case studies, send them to, or mail a disc to Sandi Hughey at Optos, 199 Forest St., Marlborough, MA 01752. Doctors must obtain written consent from the patient that the Optos images can be used for educational purposes and potentially published.

Remind kids to Wear their Sunglasses

A joint survey by the American Optometric Association (AOA) and Vision Service Plan (VSP) found that only 8% of parents make sure their child wears sunglasses when going out to play in the snow, leaving them at risk for UV damage. Many seem to associate sunglasses with the beach, but snow can reflect up to 85% of the sun's UV rays upward into the eyes. Because UV exposure is cumulative, the AOA warns, even small children should protect their eyes now to prevent problems later. O.D.s can educate parents on how to protect their family's eyes each season.



Seeking nominees. The American Optometric Association's Paraoptometric Section requests nominations for the 2006 Paraoptometric of the Year Award. The award recognizes an optometric assistant or technician who has made the "most outstanding and worthwhile" contribution to the profession of optometry, paraoptometry, and the general public. For a nomination form, call (800) 365-2210 x 222, or e-mail

Eyetech/OSI merger moves along. At a recent Eyetech stockholders meeting, more than 71% of the company's outstanding shares of common stock were voted in favor of adoption of the merger agreement.


New V.P. at Fashion Optical. Fashion Optical Displays promoted Ed Muehlberger to Vice President of Sales and Development. He'll coordinate the company's domestic and international sales staff, design staff, and its plans for corporate expansion.

ARBO names an executive director. The Association of Regulatory Boards of Optometry (ARBO) selected Jennifer L. Parker as its new Executive Director. She succeeds Thomas E. Eichhorst, who retired on August. 18.


Kowa facilitates interface. Kowa created a new software enhancement that allows complete interface with Officmate's ExamWriter program. The electronic bridge gives practitioners direct access to the ExamWriter program information without integrating ExamWriter directly into the VK2 system.

Partnership to answer imaging needs. Topcon Medical Systems and Anka Systems announ- ced a strategic partnership to integrate their proprietary imaging solutions and jointly develop new products for capturing, storing and retrieving digital information.

Allergan grows. Allergan Inc. announced a proposal to acquire Inamed Corporation, a global healthcare company. Inamed's aesthetic brand names include various dermal fillers, complementary to Allergan's Botox Cosmetic (botulinum toxin type A). The acquisition is expected to enable Allergan to offer a broad portfolio of aesthetic products and leverage significant growth and cross-marketing opportunities.


Trial for anti-cataract drop
Othera Pharmaceuticals recently began a Phase-2 clinical trial for OT-551, a topically-administered eye drop to prevent the formation of cataracts. The 12-month, double-masked, randomized, placebo-controlled study will evaluate the compound's ability to prevent or arrest the development of cataracts in patients who have undergone vitrectomy surgery. One hundred and twenty-six eyes will be treated in the study.

Patanase brings faster onset of action
Alcon says an onset of action study indicates that olopatadine hydrochloride nasal spray 665mcg brought faster allergy relief than mometasone furoate monohydrate nasal spray 50mcg for the treatment of seasonal allergic rhinitis. The study included 425 patients who had a history of seasonal allergic rhinitis and sensitivity to ragweed. Patients were randomized to a single intranasal dose of either olopatadine hydrochloride, furoate monohydrate or placebo and exposed to 12 hours of high levels of ragweed in an environmental chamber. The study was presented at the annual meeting of the American College of Allergy, Asthma and Immunology.

In the article, "Digital Slit Lamp Photography" (October '05), the correct CPT code for photography is 92285. On page 86 of the article, the captions for photographs #2 and #4 were transposed. OM regrets the error.

Optometric Management, Issue: December 2005