Contact Lenses 2002: Annual Report
Relive the major contact lens events of 2002, and see what's in store for 2003 and beyond.
By Joseph T. Barr, OD, MS, FAAO

We estimate that 87 percent of U.S. contact lens wearers wear soft contact lenses. Last year we estimated that there were 32 million U.S. contact lens wearers, and others have estimated 35 million. Whatever the number, it has changed little, if any, in the past year.

About 13 percent of Americans wear GP lenses, and new fit rate for GP lenses is below 10 percent. Nearly three-fourths of U.S. GP wearers are over age 40.

We believe nearly two-third of soft contact lens wearers have lenses intended to be disposed at one- or two-week intervals. Another 20 percent replace lenses at one to six months, and only 10 percent remain in conventional wear. This leaves only about four percent in daily disposable use.

Of these wearers, it is unlikely that more than 2 percent use bifocal contact lenses, and only slightly more than 10 percent wear toric lenses. Nearly 10 percent wear cosmetic tinted lenses.

In our June 2002 issue, CIBA Vision reported that monovision contact lens prescribing was the same in 2002 as in 2001, while bifocal/multifocal soft contact lens prescribing was up 2 percent. In the end, bifocal contact lens fitting has reached a plateau.

Perhaps a better economy and continued promotion of new products will encourage some growth in 2003.

Major Events in 2002

Silicone Hydrogel As 2002 began, Bausch & Lomb, whose PureVision lenses had been on the market for over a year, and CIBA Vision were poised to do battle over the 30-day continuous wear market, and Vistakon was primed to tell practitioners the evils of these lenses. CIBA Vision has spent over $20 million on its consumer marketing program. The company continues to invest in prac titioner and consumer promotion for Focus Night & Day lenses. Although a couple dozen ulcers from silicone hydrogel lenses may have occurred worldwide to date, there is no great alarm regarding this modality. Young smokers and swimmers are at higher risk for infiltrative keratitis with these lenses, and previous corneal inflammatory or infectious reactions are warning signs.

On June 26, 2002, the U.S. District Court (District of Deleware) ruled in favor of CIBA Vision's wholly-owned subsidiary Wesley Jessen Corp. in a patent suit (the Thomas Harvey III Patent No. 4,711,943) against B&L over contact lenses made from silicone hydrogel material. The court ruled that the patent was valid and enforceable, and that B&L infringed the patent and should cease selling and making the PureVision lens in the United States. B&L appealed after the court refused the company a stay of the injunction. On August 2, the Court of Appeals for the Federal Circuit denied B&L's request for a permanent stay of the aforementioned injunction.

Since then B&L has moved its manufacturing processes to Ireland and removed PureVision lenses from the U.S. market. Many practitioners who had numerous patients fitted with PureVision lenses were not pleased with this action. Some industry experts reported that B&L did not act efficiently to accept a licensing agreement with CIBA, while others said CIBA's terms to B&L were not acceptable.

Meanwhile, both companies sued each other over other silicone hydrogel patents. Based on previous published reports, the worse case scenario for B&L would put them out of the U.S. silicone hydrogel market until 2005 or 2014. B&L continues to deny infringement and to battle CIBA. Many industry experts have wondered about CIBA's seemingly litigious nature and how it will impact its place in the market. Our field seems to favor competition or FDA approval-based monopolies to outright patent infringement-based monopolies.

Nevertheless, currently over half a million patients wear silicone hydrogel contact lenses worldwide, and nearly 30,000 U.S. practitioners fit and prescribe Focus Night & Day lenses. In Europe, the lens is approved for a wide array of therapeutic indications.

Other News Vistakon vigorously marketed its Acuvue 2 Colours lenses to consumers and practitioners in 2002. In other Vistakon news, the company's legal challenges of 1-800 Contacts and its refusal to sell lenses to 1-800 resulted in problems for the Internet and mail order firm in obtaining Vistakon lenses, even via the gray market. In early December, 1-800 and Vistakon reached an agreement that will force 1-800 to fill prescriptions properly if it wants to purchase lenses from Vistakon.

1-800 Contacts acquired Singapore-based contact lens manufacturer IGEL to create its own lens brand and has experimented with trying to persuade patients to switch brands and trying to give incentive to practitioners to switch patients to brands that 1-800 Contacts prefers (not Vistakon products, of course).

FDA approval for Paragon Vision Sciences' Paragon CRT was not a surprise in 2002, but the ease with which the Ophthalmic Devices Panel recommended it and the scope of the approval, for up to ­6.00D, was masterful. Paragon reported that 93 percent of successful CRT patients had 20/32 or better vision, and 66 percent had 20/20 or better vision binocularly. Paragon is required to train practitioners for CRT use, which will only increase its success. Paragon is adamant about using "Corneal Refractive Therapy" to describe its treatment and to avoid using words from the past that begin with the letter "O." Paragon is cooperating with Humphreys, Carl Zeiss to market the Humphrey Atlas Topography system for corneal analysis in CRT. Paragon's success and a pending FDA approval by Polymer Technology-supported overnight orthokeratology, as well as the huge success of the Global Orthokeratology Symposium in Toronto, bode well for this alternative to other refractive corrections.

Menicon Z received FDA approval for 30-day GP continuous wear. This 163 Dk material allows better tear flow than soft lenses, resulting in great potential safety in many designs for extended and continuous wear. The lens is available from Con-Cise Contact Lens Lab. Menicon's FDA clinical study compared its Z lens with etafilcon lenses (Acuvue and Acuvue 2). The Z lens performed with better physiological results, except for expected minimal cases of peripheral corneal (3 and 9 o'clock) staining and foreign bodies under the lens.

CIBA Vision introduced Focus Dailies Toric lenses in Europe. In the United States, Ocular Sciences made progress with its special design Biomedics soft toric contact lens.

The FDA approved new claims for Alcon's Opti-Free Express multi-purpose disinfecting solution, allowing use of the term "lasting comfort," which Alcon claims results from Tetronic 1304 attracting moisture to the lens. Also, the FDA approved Alcon's recommended use of the product with no rinse step after the six-hour soaking period.

Allergan, Inc., spun off Advanced Medical Optics, Inc. (AMO), which will market its contact lens care products. Allergan introduced Refresh Liquigel, a higher viscocity drop, that it claims significantly reduces dry eye-induced corneal and conjunctival staining by 52 percent at Day 30.

Cosmetic Lenses and Controveries

Beginning late August when a British firm threatened to sue the FDA over its regulation of cosmetic (plano) contact lenses, and continuing for weeks after, Senators Waxman and Kennedy, both AAOs, the AOA, Prevent Blindness America and many others vigorously fought the FDA's consideration to reclassify cosmetic lenses to over-the-counter status. Keep in mind, this has already occurred in Europe and Canada. National television tabloids even covered the story, including a tragic corneal ulcer story out of Cleveland resulting from an illegal over-the-counter purchase of a cosmetic lens. American teens seem to have no fear of putting these colorful devices in their eyes, no matter where they were purchased or who wore them before.

Then the FDA suddenly issued a warning on October 21 and seized lenses from various outlets. Reports of infections from lenses purchased from flea markets, beach shops, convenience stores, beauty supply shops, nail salons and video stores seemed to have caught its attention. FDA can be reached at (800) 875-3001 or at www.fda.gov/opacom/backgrounders/complain.html. There is nothing wrong with the lenses; the problem is indiscriminate selling by nonprofessionals.

CIBA Vision reached a settlement with CooperVision over the Jahnke and Loshaek patents owned by Wesley Jessen. CIBA and Cooper agreed to cross license some of CooperVision's intellectual property, and Cooper will pay royalties to CIBA. A UK judge concluded that CooperVision's Frequency Color contact lenses do not infringe the Knapp patent and this patent is not valid in the UK.

CIBA Vision also filed a patent infringement lawsuit against Ocular Sciences, Inc., over five patents regarding its colored lenses. Biomedics Colors were launched in Europe in 2002 by OSI.

Contact Lens Rx Laws

Minnesota's new contact lens prescription law classifies contact lens prescriptions more like pharmaceutical prescriptions. It requires brand names, specific parameters and an expiration date as determined by the practitioner during the contact lens fitting process. It is illegal for anyone in Minnesota to dispense contact lenses without a prescription, to dispense more than a one-year supply if the prescription expires in one year and to dispense lenses different from those prescribed.

California passed a law that allows patients to obtain lenses anywhere following an examination and contact lens fitting, except for GP, keratoconus or custom designed lenses. For private label lenses, the prescription must contain the manufacturer's name and national equivalent brand name. Online and mail-order sellers must have a written prescription before filling the order or confirm the prescription with the prescriber or his agent. The prescriber must confirm the order where requested by 2 p.m. the next business day. Numerous other states will no doubt follow suit.

In Washington, D.C. in Congress (HR5657, HR2663, SB2609), within organized optometry and ophthalmology and in the FDA and the FTC, a number of contact lens Rx issues are being discussed. In 2003, a federal bill may require contact lens prescription release. At issue are passive vs. active verification and reasonable time for verification, duration of a valid Rx and enforcement by federal agencies.

Restarts and Reorganizations

In early 2002, CooperVision acquired Biocompatibles International's contact lens business and its Proclear line, including the Proclear Compatibles Toric.

Gelflex Laboratories of Perth, Australia, opened Gelflex USA in Danbury, CT, in the first half of 2002. Gelflex manufactures nearly all types of soft and rigid lenses, including the Triton translating bifocal soft contact lens.

Hydrogel Vision, under the direction of long-term industry leader Steve Schuster, acquired Benz Research and Development (makers of the Extreme H₂0 soft contact lens), then established an authorized distributor network that includes ABB Optical, Con-Cise Contact Lens Lab, Co-Optical Ltd., Diversified Ophthalmics Inc., Lensco and X-Cel Contact Lens.

Late in the year, Bausch & Lomb introduced SofLens Multi-Focal, a front surface aspheric, center-near design recommended for two-week replacement. B&L claims that practitioners preferred to keep 50 percent of their patients in this multifocal rather than return them to monovision.

Unilens introduced its new C-Vue multifocal soft contact lens, an apheric, seamlessly blended near-intermediate lens, in six packs.

Promotions and Priorities Potpourri

• VSP is poised to promote its new contact lens program, "to support patient retention and doctor success." This partnership with CIBA Vision and Ocular Sciences will encourage VSP provider doctors with a $5 "Partnership Plus" payment for each annual supply of contact lenses provided and submitted via eClaim through the Eyefinity web site. Both patient and practitioner receive special pricing in this plan. Lenses are direct delivered to the patient. VSP providers will need to defend their use of other lens types if VSP patients ask why they did not get the better financial deal that CIBA and OSI lenses offer.
• One study in 2002 found that only about 25 percent of practitioners were using manufacturer direct shipping to patients.
• Pop-up ads that promoted lowest priced contact lenses ­ save 20 to 50 percent, with free shipping for orders over $50 ­ were commonly seen in 2002.
• Independent optometrists control about 55 percent of contact lens sales, and this share is decreasing at a rate of about 1 percent per year.

While only about 15 percent of contact lens sales take place through mail order and Internet sources, one study indicates that consumers may obtain lenses that are widely advertised to them at twice this percentage through these sources.

Just as most people continue to purchase their spectacles from the practitioner who performs their eye examination, mandatory contact lens release laws will have little impact on where people buy their contact lenses.

• The Target department store chain will add up to 500 opticals in their stores.
• Consumers who purchase solutions at Walmart receive coupons for discounts on contact lenses
• Medical prescriptions written by optometrists have grown about 10 to 15 percent each year for the last four years.

Contact Lenses Increase Self Confidence

University of Warwick's June McNicholas conducted a study on eyewear and attractiveness. Thirty-eight male and female students between ages 18 and 25 were divided into three groups: those wearing their usual form of eye correction, those switching from contact lenses to glasses and those switching from glasses to contact lenses. The volunteers then went to a nightclub and were asked to report their experiences. Eighty-five percent of volunteers who had switched to contact lenses from glasses reported increased self-confidence. None of those who had switched to glasses said the same, and 75 percent complained of feeling less confident.

Good Friends Leave Us

In 2002 we mourned the loss of innovator Charles W. Neefe, outstanding contact lens practitioner Clarence Lee McEachern and our dear colleague George W. Mertz.

Prognostication

Daily disposable and continuous wear lens manufacturers forecast that more than 50 percent of lens wearers will use these two modalities by the end of the decade. Daily disposable lenses are currently inexpensive enough for many patients, and continuous wear silicone hydrogel and GP lenses are safer based on what we now know. But as we enter 2003, most practitioners still perceive daily disposing as too expensive and continuous wear as too risky. Overnight corneal reshaping will remain a niche modality, not because of safety and effectiveness, but because many practitioners are unwilling to take the time with the patient, regardless of the higher profits.

Nevertheless, we progress in this new millennium with more, better, safer contact lens options than ever. Further developments in materials, designs, manufacturing and adjunctive therapy will keep the contact lens business as least as healthy as it was in 2002.