The 1997 Annual Report on Contact Lenses

BY JOSEPH T. BARR, OD, MS, EDITOR
JANUARY 1998

Here, we chronical some critical events that occurred within the contact lens industy last year to help you prepare for what's yet to come

About 30 to 32 million people in the United States wear contact lenses, according to the Wall Street Journal, and about 75 million wear them on the planet earth, according to the International Association of Contact Lens Educators (IACLE). These numbers are growing, but don't take them as gospel because no one really knows for certain (Table 1).

In the United States, a little less than 20 percent of soft contact lens patients wear them for extended wear. And increasingly, contact lens gurus are getting sick and tired of sensational stories about how terrible extended wear is. You're more likely to have a car injury, be robbed, have an industrial eye injury or be audited by the IRS than you are to suffer an infection from extended wear. And, many practitioners believe you're more likely to lose best corrected vision from refractive surgery. So why are more and more patients gladly being referred for refractive surgery? Because there's money in it (and many of us have questioned the ethics of numerous referral practices), because it's permanent (which is good and bad news), and because there aren't sensational stories about the loss of vision -- yet. About 200,000 people in the United States (and about 1 million on the planet) had refractive surgery in 1997, and most are very happy with the result. Of course, I'm not saying you should be cavalier about extended wear (Table 2). Hopefully -- and I'm sorry to say this over and over again -- we'll have even better extended wear lens systems soon because we know 77 percent of patients want it, according to Holden's previous surveys and recent surveys by CIBA Vision (Fig. 1). Bausch & Lomb is probably ahead in clinical trials with its new high Dk soft extended wear lens, CIBA continues to investigate its product, no doubt Vistakon has a lens under investigation and Specialty UltraVision's UltraCon (carbosilfocon) will likely be investigated further for extended wear.

Table 2:  Guidelines for Contact Lens Extended Wear:

YOU SHOULD:

• Choose healthy patients eith healthy eyes.
• Inform them of the risk and precautions, i.e. to remove the lens if the eye is red, painful, photophobic or blurred.  They must see well, feel well and look well.
• fit a lens that moves and consider RGPs for astigmats.

YOUR PATIENTS SHOULD:

• Use lubricants at bedtime and upon waking.
• Remove (and if possible, replace) lenses weekly.  For two-week replacement schedules, disinfect properly (clean, rinse and disinfect in a clean case with clean hands)  and enzyme RGPs.
• Wash their hands.
• Avoid exposure to stagnate water.

Industry Trend Highlights

Ten years ago, your patients used about two lenses a year. Now it's nearly 20. Contact lenses hold about a 13 percent share of the $15 billion U.S. optical market, and although contact lens wearer numbers may be growing, the proportion of the optical market that contact lenses hold may be declining. Prices for sphericals will continually drop. Your ability to mark up lenses will continue to be challenged, and pressure to raise professional fees will endure.

Rebates abounded in 1997, with manufacturers paying patients to buy lenses and to have eye exams. Television, radio and print advertising of contact lenses was at an all time high, and practitioners prescribe the brand a patient requests in up to 85 percent of cases. Most of the practitioners I've talked to about this agree that it helps everyone.

Managed care remains a thorn in most practitioners' sides, and it's even politically correct now for the media to criticize it. Vision care benefits are valued highly by employees, but it's estimated that only about one-third of corporate plans cover eye exams and only about 20 percent cover materials. And, reimbursement for eye exams has been decreasing. Most practitioners are thankful that contact lens fees and sales supplement their limited reimbursements from third parties for other services. Optometry practice gross is up, overhead is up and net is flat.

Disposable and planned replacement lens use continues to grow and specialty lens sales continue to grow at a low-teens percentage growth rate per year. In the first quarter of 1997 compared to one year prior, disposable lenses dispensed increased 26 percent, planned replacement lenses increased 24 percent, torics increased 25 percent and multifocals increased 31 percent.

Attorneys and attorney generals continue to try to profit from the contact lens industry, with most judges seeing through their schemes and ruling against claims of conspiracy or price-fixing. In some cases, these conflicts are settled out of court.

Practitioners continue to avoid recommending contact lenses as an option to most spectacle wearers, especially astigmats who prefer to take the spectacle route believing it's more cost effective. Like Tom Hanks said in the movie "A League of Their Own," "If it were easy, everyone would do it." Most highly successful contact lens practitioners hope most of their fellow practitioners continue these habits. Many practitioners cite fashion eyewear as a big competitor to contact lenses, despite recent survey results stating that three times as many adults thought women look better without glasses and twice as many adults thought the same for men. It's estimated that one-third of spectacle wearers say they are interested in contact lenses. Yet, less than one-third of patients know about the availability of free trial lenses. Sixty percent of new contact lens wearers in 1996 were under age 25.

Another trend is the remarkable improvement in relationships between optometrists and ophthalmologists based mostly on the M.D. desire to obtain refractive surgery or other referrals and on pressures from managed care. Although there is still strong inter-professional rivalry, economic incentives provide opportunities for superficial as well as authentic improved relations. At the same time, opticians have great anxiety about being excluded from managed care plans ... even more so than optometrists.

Young O.D.s are more willing than their older colleagues to prescribe medicines, punctal plugs and to use technology such as corneal topography rather than experience to fit and prescribe contact lenses.

The FTC asked for comments on mandatory eyeglass and contact lens prescription release. While most professional organizations say they're opposed due to safety concerns, there remains a lack of strong data that this creates a public health risk. Prescription release certainly would pose a risk to many practitioners' incomes. Perhaps just over 10 percent of contact lenses are purchased outside practitioners' offices, the largest proportion probably being disposable lenses and the least likely being RGPs.

New Products

Alcon's SupraClens gained rapid acceptance with few complications. As witnessed with SupraClens and many other contact lens care and ophthalmic drug products, minimal sampling and reasonable pricing is an industry trend.

Specialty UltraVision continues to promise UltraCon (for spherical and moderate cylinder use) and EpiCon (for keratoconus and other conditions) carbosilfocon lenses. This high Dk material, which has other health care applications, could make the company a player in the future extended wear game. Patents were awarded in late 1997, and we can expect introduction in the United States in spring of 1998.

CIBA Vision (a Novartis Company) began test marketing in Norway and England Dailies, a 69 percent water content, one-day disposable lens made from nefilcon A (polyvinyl alcohol) material. We expect the lens to enter the U.S. market in 1998, driving the price of this option even lower. Having toured the manufacturing facilities for both Dailies and Vistakon's 1-Day Acuvue, I safely predict this will be a battle royale. The company also introduced Unizyme for use with AOSEPT and peroxide disinfection.

Focusing on specialty lenses, Wesley Jessen launched on a limited basis and promised wide nationwide distribution in 1998 of its Disposable FreshLook Toric at competitive prices. The company also promised a new multifocal soon, perhaps in 1998, and bought the assets of cosmetic soft lens manufacturer The Narcissus Medical Foundation.

Dicon introduced a lower priced corneal mapping instrument, which could force other manufacturers to follow suit and drop their prices.

Sunsoft launched its long-awaited, well-received Sunsoft Multiples planned replacement toric and offered contact lens ordering via the Internet. Its Sunsoft Bifocal received many votes of support in 1997 as well.

Cooper acquired Aspect Vision, Ltd., a U.K. firm which boosted its distribution in Europe and substantially expanded its mass production capabilities. The acquisition will likely influence disposable contact lens offerings from CooperVision, beginning with the Frequency 55 30-day planned replacement spherical lenses which are scheduled for a U.S. debut in February.

Bausch & Lomb introduced ReNu MultiPlus solution with Hydranate, which it claims will disinfect while reducing protein deposits by competing with calcium for protein binding sites, and Computer Eye Drops in late 1997 for "computer vision syndrome" (eye irritation from computer use). The company also purchased Storz Instrument Company, which manufactures and sells surgical and other clinical instruments, IOLs and pharmaceuticals, and Chiron Vision, which develops and sells IOLs, surgical equipment and excimer lasers. B&L also settled U.S. Security and Exchange Commission allegations of overstating 1993 earnings, agreeing to pay $42 million to shareholders who filed a class action suit. Throughout 1997, the company placed a strong emphasis on promoting its Soflens66 product. B&L also may be in the lead in clinical testing of its high Dk soft extended wear contact lens.

Vistakon released its UV absorber and inversion marker in Acuvue and Surevue with much advertising support, but later agreed to pull the ads upon request from the FDA. The company also released Vistavues, which is somewhat easier to handle than Acuvue but has no UV absorber, at $10 per 6-pack. Vistavues may allow Vistakon to compete even better than before with planned replacement and conventional wear lenses and with competitors who had lower prices on 6-packs of disposables.

Ocular Sciences became a public company, and continued to be competitive with its brand-name and private label lenses. The company is now third in market share for two-week disposable lenses and is selling two-packs of lenses for six-month planned replacement as well.

Unilens offered SoftSite multifocals in multi-packs and Unilens 38 polymacon lenses with a light blue handling tint to supplement its traditional hefilcon A clear Unilens.

More new lenses and promotions included: CT Corneal Topography lenses and C-Good aspheric multifocals from GBF laboratories, the Tangent Streak No Line multifocal, SaturEyes GMA/HEMA lenses from Metro Optics in multi-packs, LifeStyles Xtra Multifocal polymacon lenses in 1.50D, 2.00D and 2.50D adds, Blanchard's Essential Aspheric RGP and MF200 and ABCON lenses from World Optics/Nissel.

Orthokeratology

Refractive surgery and new reverse geometry (secondary curve steeper than the base curve) lens manufacturing capabilities have caused renewed interest in orthokeratology, although few practitioners employ this technique for managing myopia.

The FTC and FDA got involved in ortho-k in 1997. The FTC published for public comment in August a consent agreement with Dr. J. Mason Hurt, Memphis, Tenn., stating that the claims he made of his Precise Corneal Molding treatment, a form of ortho-k, promised unsubstantiated results at great expense to the patient. The International Orthokeratology Section of the National Eye Research Foundation began working with FTC to assure proper advertising of ortho-k modeled after refractive surgery guidelines, and it promised to work with Paragon Vision Sciences to obtain expanded FDA approval for ortho-k designs. Later the FDA issued a statement regarding off-label use of overnight ortho-k. I don't know anyone who knows how many practitioners perform ortho-k or how many patients have had it, but the numbers are likely to increase slowly since this area is underfunded and underpromoted.

Presbyopia and Monovision

Monovision was challenged in 1997 by the minor injuries reported in the case of an airplane landing accident. The pilot was wearing monovision which is against FAA rules, although pilots who have only one eye are permitted after a six-month adaptation period to fly commercial airliners. The National Transportation Safety Board claimed the probable cause of the accident was monovision plus an approach with a reduced number of monocular cues. Most expert pilot O.D.s with whom I discussed this case think the NTSB's logic is flawed. Nevertheless, few contact lens practitioners or manufacturers are likely to advertise monovision to the public, although it will continue to be prescribed. This could result in more multifocal contact lenses being prescribed.

The Challenges We Face

The major challenges to contact lens use remain: presbyopia correction, safe extended wear, proactive recommendation of contact lenses, boosting profits and preventing dropouts.

Refractive surgery will continue to grow and implantable contact lenses from Staar Surgical and other manufacturers will be approved in future years. Sure, it's intraocular surgery and could result in long-term inflammatory response or endophthalmitis, but you can bet ophthalmic surgeons will rapidly embrace this for myopia correction, especially with new, small incision surgical techniques. These phakic eye implantable lenses will likely become a common approach to correcting any refractive error.

Contact Lens Spectrum Consulting and Contributing Editors Speak Out

We asked our advisory panel which contact lens events of 1997 they considered the most important as well as what we can look forward to in 1998.

MOST IMPORTANT IN 1997

• Numerous bifocal and multifocal contact lens introductions as well as the awareness that there are many opportunities for presbyopes to wear contact lenses.

• Increased public and practitioner acceptance of UV absorbers in contact lenses.
• Alcon's introduction of SupraClens (received numerous mentions) and the introduction of B&L's ReNu Multiplus as the first comprehensive one-bottle multipurpose solution.
• The visibility of corneal mapping instrumentation and its many applications.
• Renewed interest in orthokeratology, primarily prompted by increased refractive surgery interest
• More awareness of the advantages of RGP lenses (and Ed Bennett wasn't the only one who said this).
• New RGP materials such as Polymer Technology's Boston ES, Paragon Vision Sciences' HDS, and Menicon's Z (Menicon Z received numerous mentions).
• Increased interest and implementation of RGPLI hands-on workshops in optometry programs as well as similar programs by CooperVision and CIBA Vision to increase student experience with toric, multifocal and aspheric lenses.
• Wide acceptance of the Rose K lens for keratoconus.
• Continued clinical research efforts by contact lens manufacturers.
• Consolidation of contact lens companies, particularly B&L acquiring Chiron and Storz.
• More frequent replacement options, especially toric soft contact lenses.
• Contact lenses were again featured at continuing education meetings.
• The approval of more refractive surgery procedures such as PRK for astigmatism and LASIK and the fact that more interest in refractive surgery spurs more interest in contact lenses.
• Dwight Cavanagh, M.D., Ph.D.'s research findings about infection and extended wear of contact lenses. Dr. Cavanagh had received much press coverage of his test which he claims can predict clinical success with extended wear lenses using small sample sizes.
• "Secret clinical studies sponsored by manufacturers" were mentioned as a non-event.
• Minor interest in high DK scleral lenses.
• Monovision was challenged yet again.

WHAT WILL BE THE KEY EVENTS OF 1998?

• The first successful multicenter clinical trial for a high Dk soft contact lens with B&L and CIBA Vision as the sources (received numerous mentions).
• Increased acceptance of extended wear and favorable perceptions of extended wear compared to refractive surgery.
• Vistakon's Acuvue bifocal will hit with a splash.
• Increased interest in contact lenses by presbyopes.
• Increased awareness and utilization of corneal mapping especially for contact lens fitting.

To receive references via fax, call (800) 239-4684 and request document #32.

We thank Drs. Edward Bennett, Timothy Edrington, David Hansen, Brien Holden, Randy McLaughlin, Thomas Quinn, Glenda Secor, Joseph Shovlin, Loretta Szczotka and Karla Zadnik for their participation.

Dr. barr is an assistant dean for clinical affairs at The Ohio State University College of Optometry, a diplomate of the Cornea and Contact Lens Section of the AAO and editor of Contact Lens Spectrum.