ANNUAL REPORT
Annual Report: 2003
Contact Lens Spectrum looks back at major contact lens corporate, product and legislative developments and events in 2003 and gives a preview of 2004.
By Joseph T. Barr, OD, MS, FAAO

As we enter 2004, it's time to review what happened in the contact lens and eyecare industry over the past year and see what the new year may hold in store for us.

The number of contact lens wearers may have increased by a percent in 2003. New wearers slightly outnumbered contact lens dropouts (who numbered perhaps 2.7 million) despite the soft US economy.

But the contact lens field changed forever in late 2003, when the US Congress approved (don't you love this title for legislation?) the Fairness to Contact Lens Consumers Act (HR 3140), commonly called the Burr Bill. There's little doubt that this new legislation will cause much angst among all contact lens practitioners. In the end, we believe it will change the industry less than all our concern would indicate. But it's hard to predict how this will embolden the marketing efforts of unlicensed contact lens sellers.

What Do CL Wearers Wear?

Over the past three years, visits to our offices for GP lenses rose from 13 percent to 17 percent and visits for soft contact lenses rose about four to five percent. But in 2003 visits for soft contact lenses were up.

In early 2003, our readers (400 surveyed) reported that they fit nearly 50 percent of their lens fits or refits into two-week disposables, about half that many into one- to three-month planned replacement, four percent in daily disposable and three percent in lenses approved for 30-day continuous wear. More than 50 percent of respondents expected their toric and bifocal fits and refits to increase in 2003. Just over 40 percent expected their daily disposable and 30-day continuous wear fitting to increase, with 44 percent and 28 percent respectively expecting the rate to remain stable.

Another survey (See "International Contact Lens Prescribing in 2003" by Morgan et al, page 34) indicates that US practitioners may actually fit up to seven percent of patients into daily disposable lenses and about 90 percent of patients equally into one- to two-week and monthly replacement.

Silicone Hydrogel Events

Throughout 2003, CIBA Vision's Focus Night & Day contact lens was the only US Food and Drug Administration (FDA) approved silicone hydrogel lens available in the United States. CIBA estimates that 33 percent of patients wear Night & Day for 30-day continuous wear, 13 percent for daily wear and the remainder for flexible or extended wear. CIBA claims great current growth of silicone hydrogel lens use for continuous wear and expects increased use in the future. Vistakon has noted that the percent of patients who use lenses for extended wear is stable at about 10 percent.

Law suits between CIBA and Bausch & Lomb over silicone hydrogel lens patents proliferated in 2003. In Germany, B&L won one patent battle skirmish and gained a European patent office nod to sell its PureVision lens. B&L would like to once again market its PureVision lens in the United States, and rumors at year's end indicated that some type of settlement could be in progress. In late 2003, Vistakon filed a declaratory judgement asking a patent judge to rule that its Acuvue Advance silicone hydrogel lens was outside of CIBA's patents. CIBA responded that Vistakon was infringing its patents.

Vistakon says that its Acuvue Advance contact lens with Hydraclear (an internalized wetting agent like prp) provides the initial comfort of Acuvue 2 with three times the Dk/t and better late day comfort. Vistakon designed the lens to fit like its Acuvue 2 lens, with 8.3mm and 8.7mm base curves, 14.0mm diameter and 0.07mm center thickness at ­3.00D. This center thickness allows the lens to have flexibility similar to Acuvue 2 (0.084 at ­3.00D). The Advance lens features 47 percent water content and a Dk/t of 85 at 0.07mm thickness. It does not have a surface treatment. The company also says that the lens offer the highest level of UV-blocking available, blocking more than 90 percent of UVA rays and 99 percent of UVB rays. Vistakon claims that the lens has low protein deposition and dehydrates 50 percent less than Acuvue 2. Clinical trials show that 87 percent of Acuvue Advance wearers reported they were still comfortable after nine hours or more of wear. The company has priced the lens at only a few dollars more than Acuvue 2 per six pack.

CIBA obtained FDA approval to market its Focus Night & Day lens for therapeutic use in 2003. Some industry watchers speculate that CIBA will launch a competitively priced, redesigned silicone hydrogel lens in 2004.

Contact Lens Legislation

In 2003, the federal government introduced a bill and passed a law that will both take great strides toward making contact lens wear safer and more convenient for the general public.

Congress passed the Fairness to Contact Lens Consumers Act, which mandates that practitioners provide patients with their contact lens prescriptions following a contact lens exam. Beyond this requirement, the legislation will:

• Prohibit unlicensed contact lens vendors from selling contact lenses without a prescription and from altering a prescription
• Prohibit unlicensed vendors from selling lenses to patients without direct communication with the prescribing eyecare provider. The provider must verify that the patient has a valid prescription for the lenses and confirm the accuracy of the prescription
• Require contact lens sellers to include a patient's name and address, lens power, lens manufacturer, lens fitting curve and diameter, quantity of lenses ordered and date and time of the patient's order on prescription verification requests. It would also prohibit sellers from selling lenses when the prescriber says that the prescription is no longer valid
• Require sellers to provide prescribers with all necessary information to confirm the prescription and to provide a reasonable time (such as eight business hours) to respond to requests for prescription confirmation
• Provide practitioners with protections to ensure that they actually receive and have the ability to act on prescription verification requests before the seller provides lenses to the patient
• Impose Federal Trade Commission sanctions (up to $11,000 per offense) on both prescribers and sellers who do not comply
• Set the duration of prescriptions at up to one year, or as determined by state law unless in the prescriber's judgement a documented medical complication exists that would limit the expiration date.

Certainly this process allows the prescriber time to contact the patient to attempt to provide the lenses before the mail-order firm processes the order. It also seems logical that most practitioners will need to respond to these requests on a more timely basis, similar to how they would respond to requests to refill medical prescriptions for chronic conditions.

Those who worked with the legislators, especially the American Optometric Association, noted that the lawmakers cited California's contact lens prescription law and Vistakon's enforcement of proper prescription verification, which is part of its settlement with 1-800 Contacts, as reasons to believe that this new legislation could work up to 90 percent of the time. (See November's News Spectrum.)

As this legislation goes into effect, we expect many reported instances of noncompliance. Yet it's logical to believe that most patients will continue to buy lenses from their prescribers, especially as our business practices adapt to the new requirements.

Cosmetic Contact Lens Legislation The US House of Representatives passed the plano contact lens bill, HR 2218, which amends the "Federal Food, Drug and Cosmetics Act" to recognize and regulate both corrective and non-corrective contact lenses as medical devices, regardless of their intended use. A recent article (Steinemann et al 2003) published six cases of severe red eye reactions including one case of pseudomonal keratitis resulting in penetrating keratoplasty in patients who had purchased cosmetic lenses from unlicensed sources including flea markets, gas stations, hair salons, grocery and convenience stores. This legislation will require consumers to have a prescription to purchase the lenses.

Recapping Corneal Reshaping and GP CW

Paragon Vision Sciences estimates that nearly 1,800 practitioners received training to provide corneal refractive therapy with Paragon's CRT method in 2003, and CRT procedures were growing at a rate of about 25 percent per month by mid-year. That could translate to as many as 65,000 to 86,000 patients undergoing this procedure annually. We believe that at year's end, one other manufacturer had pending approval for overnight corneal reshaping.

The SARS scare cancelled the Global Orthokeratology Symposium in Toronto in 2003. GOS is now rescheduled for July 22-25, 2004 in Toronto.

Menicon has expanded its distributor network to include ConCise Contacts, ABB Optical, Diversified Ophthalmics and soon Firestone Optics, Inc. and Truform Optics.

Looking to the Future

What's in store for the contact lens industry in 2004? CIBA predicts that by 2005, more than 1.7 million patients will wear continuous wear; one million each will wear one- to two-week toric and one- to two-week cosmetic lenses; 600,000 will wear daily disposable lenses; and 300,000 will wear bifocal disposable lenses. This translates to percent increases in these categories of 330, 70, 42, 54 and 33 percent, respectively. New lenses designed to stem the tide of dropouts will be a theme in 2004.

To obtain references for this article, please visit http://www.clspectrum.com/references.asp and click on document #102.

Dr. Barr is the editor of Contact Lens Spectrum and is Assistant Dean for Clinical Affairs at the Ohio State University College of Optometry.