The 1998 Annual Report on Contact Lenses
The world of contact lenses has expanded over the past year. This report is an exploration of the events and innovations creating new opportunities for you and your practice.
BY JOSEPH T. BARR, OD, MS, Editor
It's possible there are about 33 million contact lens owners in the United States and nearly 75 million contact lens owners on the planet. The U.S. market for manufacturers sales is about $1.5 billion. Thus, about 10 percent of Americans wear contact lenses and about eight percent of optical industry sales are for contact lenses. The 70 million-plus baby boomers in the United States could consume mass quantities of contact lenses for presbyopia, as could their 70 million-plus offspring, who have an unprecedented amount of options with unprecedented levels of safety available to them in contact lens wear.
Most habitual contact lens wearers will pay up to $250 to $300 per year for contact lens care products, which leaves about $100 to $150 profit for the provider. They also typically acquire a comprehensive eye examination every year or two, occasional checkups depending on their prescription, spectacles and plano sunglasses. Table 1 illustrates the current contact lens usage patterns in the United States.
Few of you, however, care about this big picture. So this article will focus on the many products and issues that have an impact on your practice.
One-Day Disposable Lenses
Early in 1998, CIBA Vision launched in the United States its new single-use Focus Dailies lens, manufactured in PVA material using ultraviolet Lightstream Technology. After much success with launches in Norway and the United Kingdom, and priced less than its competitor's daily disposable lenses, CIBA's success with the lens in 1998 was limited only by manufacturing capacity. With expanded capacity, CIBA will make progress with Dailies.
Bausch & Lomb launched SofLens One Day lenses (70 percent water content hilafilcon material) in England and will do the same in the United States in 1999. Bausch & Lomb previously acquired Award PLC to position itself for the one-day market, which is expected to grow to 10 to 15 percent of wearers in the early 2000s.
Late in 1998, Vistakon began offering its 1-Day Acuvue at a lower price in some instances. B&L, CIBA and Vistakon expect much growth in the number of users of one-day replacement lenses in the next five years. Ocular Sciences, Inc. may introduce a one-day product in 1999 as well. Although there is little argument that one-day contact lenses are great for the occasional wearer, many experts wonder which will be the preferred choice in the future -- one-day or extended wear contact lenses.
As we have pointed out before, the glut of contact lenses continues. In July of 1998, Wesley Jessen issued a news release indicating "troubling implications for the future." Nearly 70 percent of contact lens wearers use blister pack products. Disposable lens costs have been reduced by five to 10 percent, with mass merchants selling lenses at less than $15 per six-pack, according to Wesley Jessen. Some suggest this is counterproductive to contact lens market growth due to reduced practitioner profitability. Wesley Jessen also announced reduced pricing on Gentle Touch lenses by over 25 percent per lens to make it suitable for monthly replacement.
Bifocal and Multifocal Contact Lenses
Vistakon had much success in 1998 with its new center distance, multiconcentric zone Acuvue Bifocal. Using specific instructions and many free trial lenses to efficiently test acceptability, practitioners have found that many patients can be "20/happy" with this lens.
Sunsoft launched its center near, aspheric planned replacement Additions bifocal and discontinued the Sunsoft MultiFocal.
Acuity One, LLC introduced the aspheric UltraVue hioxifilcon glycerol methacrylate lenses. The system includes the UltraVue P lens for distance and the UltraVue C lens for near. The LifeStyle Company launched aspheric MV2 lenses, which include a near eye lens that has an intermediate zone with more minus, and a distance lens that has an intermediate zone with more plus. Although these two companies differ in their approach, their lenses and similar approaches from other labs offer an improved form of modified monovision.
Paragon found its HDS material well-received and introduced its Paragon Thin material with a lower Dk (29 Revised Fatt and 26 ISO/ANSI Fatt) to be made in minus lenses with a center thickness as low as 0.06mm. Some RGP laboratories also introduced thin lens designs such as the Art Optical ThinSite lens, made with its thin Smartcurve design, and Excel Thin from Excel Labs. Finally, RGP lenses are getting back to the thinness available in the late days of PMMA lenses and with the Polycon lens designs. In fact, Wesley Jessen relaunched Polycon and Fluorocon in 1998.
Polymer Technology promoted its new Boston EO material with a higher Dk (82 or 58 ISO/Fatt) than its already popular ES material (Dk 32). Menicon emphasized its Menicon Z product in 1998. Stellar Contact Lens added a UV absorber to its OP-2, OP-3 and OP-6 products.
There is still some misunderstanding about Dk values in the contact lens field, but progress is slowly taking place to minimize disagreement and standardize Dk claims. (See guest editorial by Dr. William "Joe" Benjamin in Contact Lens Spectrum, Oct. 1998, p. 16, as well as "Dk/L: Into the Ultra-High Zone," by Drs. Richard Hill, Bradley Smith and Barbara Fink in this issue).
The Contact Lens Manufacturers Association announced the recipients of its Seal of Manufacturing Excellence award. A list of these labs is published in our December 1998 issue.
Current Usage Pattern
PRK and LASIK
Hyperopia accounts for only about six percent of the contact lens market, and refractive surgery for hyperopes will have little impact. Nevertheless, the FDA approval in 1998 of the VISX Star S2 excimer laser for hyperopic PRK was a major event. Over 100,000 myopic and astigmatic PRK procedures and as many as 350,000 LASIK procedures may have been performed in the United States in 1998. Hyperopic and astigmatic procedures and the KeraVision corneal ring procedure will see much growth in 1999. The "intraocular contact lens," phakic IOL looms as a common refractive procedure in the years beyond 2000.
In May, the FDA approved the Contex OK lens for daily wear orthokeratology. In October, the FDA issued a warning that practitioners should be careful to not make claims about ortho-k that are unwarranted, that some laboratories are illegally selling and promoting lenses for ortho-k and that overnight ortho-k is risky. The FDA admits that it has no data to support overnight orthokeratology risk and that it is trying to obtain data to support these concerns.
Using RGP lenses approved for extended wear and specifying reverse geometry lens designs to flatten the cornea to a shape similar to that provided by refractive surgery is permissible if the practitioner specifies the design and the material. The FDA has worked diligently over the years to control this off-label use of drugs and devices.
Many practitioners believe that the FDA's stance, which discourages overnight orthokeratology, is prompted by refractive surgeons. If so, perhaps their concern suggests the procedure may be effective enough to cause competition for refractive surgery in the case of low myopia. More likely, the refractive surgeons are just extremely skeptical and naive about modern orthokeratology.
Numerous labs are investigating daily orthokeratology for FDA approval. In late 1998, the National Eye Research Foundation, which carries the banner for many orthokeratologists, began working with the FDA and FTC to prepare guidelines for "proper" ortho-k promotion. NERF's International Orthokeratolgy Section asked the FDA for a summary of the adverse events caused by RGP lenses. Euclid Systems Corp. and Polymer Technology Corp., using Dr. Thomas Reim's DreimLens reverse geometry lens design, the Equalens II material and Euclid's corneal mapping system, are conducting FDA clinical trials with the Euclid Orthokeratology lens. Paragon is investigating numerous reverse geometry ortho-k lens designs, especially one by Jim Day, O.D. The future of orthokeratology depends on good research of its overnight application.
Over 40,000 patients purchased Wesley Jessen's Wild Eyes lenses in 1998, according to the company. The FDA issued a notification in October, warning practitioners that some small companies who distribute tinted soft lenses may be doing so without proper FDA clearance. The FDA is concerned about the safety of these devices, and large manufacturers are concerned about the unfair competition.
The FDA also issued warnings in 1998 about what it considered excessive UV-absorbing lens claims. All of these FDA contact lens warnings would make you think that there are some major risks of contact lens wear. Yet the real safety risk seems unidentified to date. Some people believe the FDA needs to spend more time working with manufacturers and less time issuing warnings to practitioners for real progress to occur.
Torics and Other Specialty Lenses
Bausch & Lomb finally launched its new two-week replacement Soflens66 Toric lens late last year.
CooperVision introduced Frequency 55 Toric monthly replacement and Hydrasoft Toric Options custom planned replacement lenses. The company also moved its higher volume spherical lens manufacturing to Southampton, England, after acquiring Aspect Vision Care in 1997. This move will improve toric contact lens manufacturing capacity in the United States.
Wesley Jessen maintained emphasis on its FreshLook Toric disposable lens.
Paragon Vision Sciences emphasized its Flexlens Products in 1998. These include soft tricurve and the piggyback designs for keratoconus, torics, aphakic lenses, including pediatric applications, the Harrison Post Refractive Surgery lens and the McAlister "Mega" (19.5mm diameter) lens for post-filtration surgery for glaucoma.
Bausch & Lomb and Alcon debated the effectiveness of ReNu MultiPlus and the claim that patients need no extra enzyme products with this lens care regimen. Alcon's SupraClens gained even broader support. Allergan offered Complete Comfort Plus with the claim of protein removal. Lobob products were reintroduced and Specialty UltraVision offered MPS solution for RGP and soft contact lenses.
For RGPs, the Boston One Step Liquid Enzymatic Cleaner was introduced and well accepted in 1998. This solution is simply dropped into Boston conditioning solutions for routine enzyme cleaning. Liquid enzyme cleaners are a significant improvement in contact lens care.
Managed care accounts for nearly 25 percent of vision care and this percentage is expected to double early in the next century. Since most managed vision care plans offer eye examinations with reduced fees and reduced patient cost on goods, patients in these plans are probably more likely to see their eyecare practitioner and to upgrade to more expensive, better options. These factors can be beneficial for practices that are prepared to care for contact lens candidates.
Other Notable Events of 1998
A new ANSI Z80 contact lens standard was published in 1998, and you can contact the Contact Lens Manufacturers Association or the Optical Laboratories Association for a copy of these standards. Biocompatibles Eyecare, Inc. obtained FDA approval to claim its Proclear brand lenses "may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear." CIBA renamed all of its products to the Focus brand name, including NewVues two-week replacement lenses and its lens lubricant (Focus Lens Drops). Specialty Ultravision continued to pursue development and FDA approval of its high Dk, flexible carbosilfocon material lenses. Alcon promoted Tears Naturale punctal plugs and promised to introduce a new, more user-friendly system to plug the puncta. The American Optometric Association (www.aoanet.org) announced new guidelines for contact lens use in industrial environments.
Contact Lens Issues in 1999
Extended wear -- Oliver Schein, M.D., of the Wilmer Ophthalmological Institute at Johns Hopkins University has predicted that the rate of loss of best corrected visual acuity from current extended wear is 1/300 per decade, from daily wear is 1/25,000 per decade, and from excimer ablation procedures is 1/100 to 5/100 per decade. These complication rates must be evaluated relative to the common improvements in quality of life that patients experience as a result of these procedures.
Will the next generation extended wear lenses reduce the risk? Certainly the problems related to hypoxia (such as corneal thickness change, endothelial polymegethism, neovascularization) will be resolved with these 100-plus Dk/t lenses. Optometrists, who prescribe the majority of contact lenses, are now more prepared to manage many of the complications associated with extended contact lens wear, which was not the case 15 years ago when extended wear use first grew. Thirty-day extended wear studies with these lenses are underway, but initial approval will be for seven days.
Will Bausch & Lomb introduce its PureVision (balafilcon) silicone-hydrogel lens for seven-day extended wear? Many of us hope it will. With very high Dk and good surface quality, this lens may offer us more confidence in recommending extended wear for our myopic patients. Nearly three-fourths of myopic patients have said in numerous surveys that they would try a high-Dk extended wear lens, especially if the lens were recommended to them for 30 days of extended wear.
At the end of the year, CIBA Vision began a test market introduction in Mexico of Night & Day, its 175 Dk/t lotrafilcon A fluorosiloxane hydrogel, for up to six nights of extended wear.
Will Bausch & Lomb and CIBA Vision promote their PureVision and Night & Day lenses to the consumer or only through professionals? Will the manufacturers of new extended wear lenses and the FDA agree to post-market surveillance? Will many practitioners who do not recommend extended wear lenses now change their paradigm and begin to recommend them? Or, will most practitioners prefer to recommend and comanage profitable refractive surgery patients? What will be the replacement cycle, cleanliness and cost, and will it ultimately be worth our while to recommend, fit and monitor the extended wear high Dk/t lens patient? Early clinical results on these lenses are very impressive.
Daily disposables -- Some industry observers wonder if daily disposable contact lens cost reductions could obsolete many current spherical disposable lenses or even extended wear lenses. Certainly more competition in this area will promote lower cost and more patient awareness. And of course, few disagree that this is the safest way to wear contact lenses if the prescription suits the patient. At a dollar-a-day cost to the patient, less than the cost of a newspaper and cup of coffee for clear, comfortable vision, this may become an easier recommendation to make for the everyday wearer as well as the occasional wearer.
Mail-order -- All over the planet, alternative, non-licensed dispensing of contact lenses is expected to grow unless public health risk can be demonstrated with significant data.
Access to Contact Lens Information -- Throughout the upcoming year, we'll continue to offer our best effort to help you, your patients and your practice thrive as the world of contact lenses continues to grow. Remember, for weekly updates about the contact lens field and related topics, go to www.cltoday.com and sign up for our free weekly e-mail newsletter. Also, be sure to visit Contact Lens Spectrum on the Web at www.clspectrum.com.
Dr. Barr is assistant dean of clinical affairs and an associate professor at The Ohio State University College of Optometry. He is a diplomate in the Cornea and Contact Lens Section of the American Academy of Optometry, a member of the International Association of Contact Lens Educators, and has been editor of Contact Lens Spectrum since 1988.