ANNUAL REPORT
Contact Lenses 2005
A look back at the major events and developments in the contact lens industry in 2005 and predictions for 2006, with emphasis on advancements that have enhanced contact lens vision and comfort.
By Joseph T. Barr, OD, MS, FAAO

It's a great time to be involved in the contact lens field, which grew in 2005. New product introductions continue at a record pace. There are about 36 million contact lens wearers in the United States, and they represent about 20 percent to 35 percent of many practices. New research indicates that contact lens patients are more profitable for your practice compared to spectacle-only patients — we'll bring you more information on contact lens profits later in the year.

World Market Overview

Globally, approaching 90 percent of lens wearers wear disposable and planned replacement contact lenses. Daily disposables garner about 6 percent of wearers, with growth expected in this modality. Only 7 percent of wearers use conventional lenses, and most of these patients wear their lenses until they hurt or are lost or torn. GP lenses represent only about 6 percent of the global market and approximately 10 percent to 13 percent of the U.S. market. Extended wear, though less complicated than ever, returned mixed sales reports.

U.S. Statistics Toric lenses account for about 20 percent of the U.S. market in sales dollars. Practitioners fit 2.5 percent of the 100 million U.S. presbyopes with soft contact lenses; half wear monovision and half wear multifocal lenses. But a 20-percent growth in multifocal sales dollars occurred over last year. The average age of U.S. contact lens wearers is 38.

Overall, the U.S. contact lens market grew about 10 percent in sales dollars in 2005. Soft contact lens office visits were up 18 percent over the end of 2004, and fit and refit visits rose 24 percent over the same time period. Total office visits were up in the first, second and third quarters of 2005, rising from 5.8 million in the fourth quarter of 2004 to 6.9 million in the third quarter of 2005 (Health Products Research [HPR] data. HPR is a company that audits eyecare professional dispensing of contact lenses). New fits and refits went from 3.3 million to almost 4.2 million over the same time period.

Last year about 2.8 million wearers dropped out of lens wear in the United States, which was balanced out by about 3 million new fits over the most recent year. Determining how to regain dropouts and to prevent current wearers from dropping out is a goal for all manufacturers, serious practitioners and researchers.

Manufacturer Data Johnson & Johnson Vision Care (Vistakon) led the global market share by company of the contact lens market in 2005 at about 33 percent; CIBA Vision tallied about 27 percent of the global market share, while CooperVision had about 16 percent and Bausch & Lomb about 15 percent. In the U.S. market, Vistakon had about 35 percent of the market share, while CIBA Vision had about 25 percent as did CooperVision with the acquisition of Ocular Sciences. U.S. contact lens sales at the manufacturer level are about $1.8 billion of the worldwide $4.5 billion market.

Growth in the Silicone Hydrogel Market

Silicone hydrogel contact lens sales growth is remarkable. Although silicone hydrogel wearers still comprise a little less than 10 percent of the wearer base, fits and refits grew from 5 percent to 25 percent in 2004.

According to CIBA, data just released from the A.C. Nielsen Company reveals rapidly expanding demand for all types of silicone hydrogel lenses. For the bimonthly reporting period ending in February 2005, audited U.S. retail sales of silicone hydrogel lenses increased by 161 percent over the same period the previous year, driving total soft contact lens sales up 12 percent. Silicone hydrogels accounted for 19.4 percent of soft lens retail sales, compared to just 8.3 percent in January/February 2004.

The continuous wear segment of the silicone hydrogel market also continues to expand rapidly, up 41 percent in retail sales during the first two months of 2005. HPR released data indicating that silicone hydrogels accounted for 29 percent of new soft lens fits in the United States in the first quarter of 2005 compared with 17 percent the same time last year.

Vistakon launched its Acuvue Oasys (senofilcon A, 38 percent water) silicone hydrogel lens for daily wear in late August. On July 11th, CIBA Vision filed a suit against Vistakon regarding Acuvue Oasys for infringement of its "Nicolson" patents, which the company says protect its Night & Day and O₂Optix contact lens technology. CIBA sought a temporary restraining order to prevent Vistakon from manufacturing, marketing and distributing Acuvue Oasys. However, a U.S. district court in Jacksonville denied CIBA's motion for a temporary restraining order to halt the launch of Acuvue Oasys contact lenses, and Acuvue Oasys remains available to eyecare professionals. The lens has a Dk of 103 and offers Hydraclear Plus as its internal and surface wettability agent. The lens absorbs 100 percent of UVB and 96 percent of the UVA light. This two-week replacement lens has a Dk/t of 147. Meanwhile, Vistakon made much progress with its new Acuvue Advance for Astigmatism, which features a unique non-prism stabilization design.

Bausch & Lomb's silicone hydrogel lens is available in the United States once again, following the successful resolution of a patent dispute with CIBA. The FDA also approved and B&L launched its PureVision Toric (balafilcon A) contact lens for sale in the United States. It's indicated for the correction of myopia and/or hyperopia with astigmatism of up to 5.00D and is designed for monthly replacement. The FDA has approved the lens for either daily wear or up to 30 days of continuous wear.

Table 1 (courtesy of Carla Mack, OD) lists the parameters and properties of currently available spherical silicone hydrogel lenses.

CooperVision's new Biofinity silicone hydrogel will arrive in the second half of 2006 for daily wear. Manufactured in comfilcon A, a 48-percent-water, 160-Dk/t material that requires no surface treatment, parameters of this two-week lens will include an 8.6mm base curve and 14.0mm diameter. This lens has higher Dk than other silicone hydrogels of the same water content, and comparative tests show less conjunctival impingement than some other silicone hydrogels because of its edge design.

Hydrogel Lens Advancements

CooperVision's New Lenses CooperVision just launched Biomedics XC, a two-week replacement, aspheric, daily wear lens manufactured in omafilcon A phosphorylcholine (PC) material (60 percent water, Dk 33, Dk/t 44) and available with an 8.5mm base curve and 14.2mm overall diameter. CooperVision claims that the new lens fits like its Biomedics 55 UV and 55 aspheric designs. CooperVision reminds practitioners that this material has an FDA indication for preventing contact lens-related dryness.

The company also introduced its CooperVision Biomedics EP, a Balanced Progressive Technology D lens for OU prescribing, manufactured in the Biomedics XC 60-percent water material for emerging presbyopes with up to +1.50D add. CooperVision reports a success rate of 92 percent in selected patients in trials with this lens.

CooperVision also expanded its line of contact lenses with the new UltraVue PC multifocal toric lens. The new lens is manufactured in omafilcon A PC material and uses Cooper's Balanced Progressive Technology D lens for the dominant eye and N lens for the non-dominant eye. The company says this method enables good stereopsis in toric prescriptions. The lens is available in made-to-order parameters in single lens vials.

Improved Focus Dailies CIBA's Focus Dailies contact lenses now feature AquaRelease, a moisturizing agent comprised of a specific molecular weight polyvinylalcohol (PVA) that releases gradually into the tear film during wear. The PVA begins to diminish at the end of the day to ensure patient compliance with the wear schedule. Focus Dailies are made of PVA (nelfilcon A) material and feature a handling tint.

B&L Gets Sporty Nike MaxSight sport-tinted contact lenses by Bausch & Lomb are available in the United States and Europe. The lenses are designed to aid visual performance by selectively filtering specific wavelengths to reduce glare in sports. The grey-green tint is designed for sports played in bright sunlight such as golf and running. The amber tint is designed for fast-moving ball sports such as tennis, soccer and football. Figures 1 and 2 show the light architecture for the amber tint and the grey-green tint, respectively. Both tints come in plano or prescription and are indicated for daily wear.

Menicon Enters Daily Disposable Market Menicon Co., Ltd. launched its first daily disposable soft contact lens, Menicon 1-day, in Japan, which is the second largest contact lens market next to that of the United States. Menicon 1-day is made of ocufilcon D material and is manufactured by liquid edge molding technology to produce a lens that the company says provides stability and smooth edges.

Menicon also now offers a complete line of contact lens care products, with the launch of MeniCare Soft and MeniTears this past June at the British Contact Lens Association annual conference. MeniCare Soft with Comfortec is a polyhexanide-based multipurpose solution. Menicon indicates that the solution provides high antimicrobial activity, low toxicity and excellent comfort for all soft contact lenses. MeniTears, manufactured by Advanced Vision Research, is a preservative-free lubricant eye drop, packaged in single doses. The patented hypotonic formula is approved for all soft, GP and silicone hydrogel contact lenses. Both products will soon be available in the United States. 

Lens Care Update

Considering that at least 25 percent of the multipurpose contact lens care solutions that our patients purchase are obsolete, inexpensive private-label versions, it's now more important than ever to strongly recommend or even prescribe the lens care brand we want our patients to use. B&L's ReNu with Moistureloc and Alcon's Opti-Free Express are the market leaders, followed by AMO's Complete MoisturePlus and CIBA Vision's Aquify. Sauflon Pharmaceuticals also introduced its All In One Lite No Rub Multipurpose Solution, available only through eyecare practitioners. All are manufacturer recommended for silicone hydrogel lenses.

A new solution that has just become available is Alcon's Opti-Free Replenish Multipurpose Disinfecting Solution for use with all soft contact lenses, including silicone hydrogels. This new formulation of the company's original product contains Tearglyde, a wetting system that the company says keeps lenses fresh and moist while maintaining compatible disinfection and reconditioning based on its extensive 927 total patient studies. Tearglyde combines Tetronic 1304 and C9 ED3A to interact with the lens surface and tear film to improve surface wettability even after 12 hours of wear, according to Alcon.

Much activity has occurred in the area of contact lens care research including recent findings that both ReNu with MoistureLoc and Complete MoisturePlus have greater ability to stabilize and retain lysozyme in its natural state on the lens surface.

Surface wettability competitive data are proliferating both for contact lenses and for solutions. It's again clear that contact lenses, especially silicone hydrogels, need to be rubbed to remain clean.

Developments in Ortho-k/CRT and GPs

At the Global Orthokeratology Symposium, Helen Swarbrick, Dip Opt, PhD, discussed the risk of corneal ulcer from overnight orthokeratology, which is higher in Asia. Joe Sicari of Paragon Vision Sciences indicated that up to 20 million people are interested in overnight corneal reshaping if it's priced under $1,000 while 10 million are interested if it's priced up to $1,500.

Jonathan Jacobson of B&L reported that motivation for ortho-k varies around the world, with trends toward more interest in cosmesis in the United States as compared to relatively more interest in myopia control in Asia. Recent data on minimal retardation of myopia progression with GP lenses (Walline 2005 and Cho 2005) have not yet spurred the GP field substantially, but hope remains.

B&L offered eyecare professionals a Web site (www.bausch.com/vst) that provides online training and certification necessary to fit the company's new Vision Shaping Treatment (VST) for overnight orthokeratology. VST is a system involving several ortho-k lens designs fit both empirically with keratometry or diagnostically with topography and software. The lenses are made of Boston Equalens XO GP material and come in four designs: BE retainer (Precision Technology Services, Ltd), Contex OK E-System (Contex), DreamLens (DreimLens, Inc.) and Emerald (Euclid Systems Corp). Contex offered its own meetings to train practitioners in fitting overnight ortho-k.

The Contact Lens Manufacturers Association (CLMA) met in October in Las Vegas. Meeting highlights included a keynote address by Editor Joe Barr, OD, MS, FAAO, who recommended that CLMA emphasize expanded use of workshop training on GP and specialty lens use. Earl L. Smith III, OD, PhD, and Patrick J. Caroline, FAAO, gave an outstanding lecture that focused on the link between peripheral blur and myopic progression and offered contact lens strategies for treatment.

New Hybrid Lens Technology

SynergEyes, Inc. received approval from the FDA to market its SynergEyes A hybrid contact lens for correcting hyperopic, myopic and astigmatic refractive errors, as well as presbyopia. The new lens is designed with a high-Dk (Paragon HDS 100) rigid center (8.2mm wide) with a hydrophilic, non-ionic soft skirt (30 percent water, 14.5mm diameter) to treat ametropia from –20.00D to +20.00D with up to 6.00D of astigmatism. The company says its HyperBond junction technology creates a durable interface between soft and rigid portions of the lens, which has been a problem with previous hybrid lenses.

Investigating Corneal Infiltrates

While reports surfaced that silicone hydrogel lenses do not seem to reduce the rate of microbial keratitis in extended or continuous wear but may reduce the severity, researchers from the University of Manchester examined the incidence of vision loss for contact lens patients who presented to a hospital with corneal infiltrative events (CIEs). They also looked at the incidence of CIEs with different lens types and materials. Over a 12-month period, no patient suffered significant vision loss as a result of a CIE. The researchers concluded that the risk of developing CIEs is eight times greater for patients who sleep in their lenses compared with those who wear their lenses only during waking hours. The study (Efron 2005) also found that silicone hydrogel lenses are the best option for patients who choose to routinely or intermittently sleep in their lenses because CIEs are less severe with silicone hydrogels than with other lens materials.

Legally Speaking

2005 also saw its share of legal battles, legislation and continuing repercussions from the 2004 Fairness to Contact Lens Consumers Act (FCLCA). Dk battles are being waged in the marketplace (see Editor's Perspective on page 13) and silicone hydrogel patent battles are being waged in the courts.

FCLCA and Nonprofessional Sellers 1-800 Contacts CEO Jonathan Coon blames a third-quarter dip in profit margins on restrictions on contact lens distribution. Mr. Coon specifically mentions a legislative resolution (See "Senate Proposes Less Restriction on CL Distribution" below) that the company expected to close what he calls the "doctors only loophole" in the FCLCA. "The effect on a consumer trying to use a 'doctors only' prescription for purchase from a non-ECP seller is the same as if the prescription had never been released," said Mr. Coon. He further explained that, "Addressing the threat of 'doctors only' lenses must be our top priority," adding that the company will divert advertising spending to fund initiatives towards this goal.

1-800 also made claims that the verification practices of one of its competitors, Coastal Contacts, had also played a part in the company's declining profits.

The FTC issued a formal warning to an unnamed leading contact lens seller for violating the FCLCA. The enforcement action was prompted by American Optometric Association member complaints. FTC's October warning cites prescribers not having adequate opportunity to respond to requests by the seller for prescription verification.

Although not named in this statement, 1-800 Contacts has been the subject of many complaints regarding busy fax and phone lines and autodialer mechanism issues. In related FTC actions in New York and Pennsylvania, a test shopper program revealed that prescribers were writing prescriptions regularly and no further action was needed in this test. You can contact the FTC at www.ftc.gov or by calling (877) FTC-Help (382-4357). Our recent Contact Lens Spectrum survey indicates that too many prescribers are not filling prescriptions (see December 2005 Editor's Perspective).

Senate Proposes Less Restriction on Contact Lens Distribution At one time in 2005, pending legislation in the U.S. Senate would have required contact lens manufacturers to guarantee availability to alternative suppliers, regardless of whether the supplier is affiliated with any prescriber. HR 2744 is entitled, "Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2006." Robert F. Bennett (R-Utah) had proposed an amendment (S10314) that would prevent the use of any federal funds for the review, clearance or approval of any contact lens unless the manufacturer certified that its lenses are distributed in a non-discriminatory manner, directly to alternative channels of distribution. This would have restricted the FDA from reviewing any applications from companies that do not make lenses available directly to all channels of distribution such as mail-order houses, Internet retailers, pharmacies, buying clubs, and other distribution alternatives.

The author of the proposed amendment noted that this should not be interpreted as waiving any obligation of sellers under the FCLCA, which would also have been amended to reflect this change. Under such new requirements, a prescription would still be necessary for patients to obtain contact lenses, but manufacturers would have to sell to just about anyone. This could increase contact lens availability without a prescription.

You may wonder what prompted such legislation. Certainly it wasn't an interest in increased public health and healthy contact lens wear. It was certainly economically motivated. At the close of 2005, the legislation did not contain the mandatory distribution clause — but it's believed this issue isn't dead.

Cosmetic Costume Lenses are Now Medical Devices A few days before Halloween, the U.S. House of Representatives passed S. 172, a bill that amends the Federal Food, Drug and Cosmetic Act to protect patients from eye injuries resulting from the misuse of decorative contact lenses. The act now carries the stipulation that all contact lenses are medical devices. The Senate approved the bill in July and President Bush signed it into law. Since 2003, the FDA has issued warnings to consumers and acknowledged receiving reports of corneal ulcers, infections and loss of vision associated with decorative lens wear.

Glancing Ahead

B&L, CooperVision and other manufacturers are offering lenses that reduce spherical aberration. Look for more wavefront correction lenses to come your way in the months and years to come.

To obtain references, please visit http://www.clspectrum.com/references.asp and click on document #122.

Dr. Barr is a professor and associate dean for clinical services and professional program at The Ohio State University College of Optometry.