ANNUAL REPORT

Contact Lenses 2007

A look back at contact lens events of 2007 including prescribing trends, product recalls and launches, compliance issue, mergers and corneal staining.

By Carla J. Mack, OD, FAAO

Dr. Mack is director of clinic services and an associate professor of clinical optometry at The Ohio State University College of Optometry.

In 2007, the contact lens industry was graced with growth and product innovations; it was also once again immersed in solution controversy and more than one voluntary product recall. Several patient surveys have made it clear that our patients need better education, both on compliance and availability of current products. For practitioners, this is an opportunity for increased patient communication and practice growth. The global contact lens industry continually amazes me in that it varies so drastically by region and country, yet the good news for all is that industry growth continues.

Market Trends

Controversy aside, the ophthalmic sector as a whole is up 250 percent over the last five years, which is far ahead of the S&P 500. The contact lens industry remains healthy with industry analysts predicting 7 percent to 8 percent growth both for the United States and worldwide over the next few years. Data obtained from Jeff Johnson, OD, MBA, a senior medical technology analyst with Robert W. Baird & Co. Inc., estimate the worldwide soft contact lens market at $4.8 billion and the U.S. market at $1.8 billion. The worldwide GP lens market contributes another $250 million. Market share by company is similar for the United States and worldwide with Johnson & Johnson dominating at nearly 45 percent. Worldwide soft lens market share for CIBA Vision is 19 percent, followed by CooperVision at 16 percent and Bausch & Lomb at 15 percent.

Worldwide soft lens market share is greatest for daily disposables at 33 percent, followed by a combined silicone hydrogel sphere and toric category at 24 percent (Figure 1). The U.S. daily disposable market share is at 10 percent (Figure 2), up from 7.5 percent in 2005 and 8.5 percent in 2006.

Silicone Hydrogels Silicone hydrogel conversion continues, particularly in the United States at 46 percent of the U.S. contact lens revenue compared to just 15 percent in 2004. The second half of 2007 saw the entry of CooperVision's Biofinity and the re-emergence of CIBA Vision's O₂Optix. It should come as no surprise that silicone hydrogel torics are also growing rapidly with nearly 45 percent silicone hydrogel toric penetration expected for 2007 versus less than 10 percent penetration in 2005. Looking at revenue, Figure 3 shows silicone hydrogel revenue for the last few years and a projection of revenue for 2008 in the United States. Figure 4 shows the revenue breakdown of silicone hydrogel lens modalities for 2007. Silicone hydrogel toric lenses account for nearly 35 percent to 40 percent of all toric lens revenue. With both industry and survey data indicating that all silicone hydrogels will continue to grow over the next few years, expect revenue driven by this option — which commands a premium price — to grow as well.

Lens Care Market A.C. Nielsen data on solution market share through 2007 shows that private-label solutions represent one quarter, with all Alcon products at 39 percent. Multipurpose solutions still dominate share at about 89 percent with hydrogen peroxide-based systems at about 11 percent. ClearCare claimed 9 percent of the 11 percent share. These data do not include Wal-Mart or "club segments" (Costco, Sam's Club, BJ's) but do include other mass merchandisers and grocers. These data also reflect AMO Complete MoisturePlus through May 2007 and Complete Multi-Purpose Solution Easy Rub Formula's entry in August.

Figure 1. Daily disposable spherical lenses are most prescribed globally.
Source: Company reports, Robert W. Baird & Co, Inc. estimates.

Figure 2. Silicone hydrogel lenses lead the U.S. market.
Source: Company reports, Robert W. Baird & Co, Inc. estimates.

According to data on file from CIBA Vision, 3rd quarter 2007 retail sales showed the hydrogen peroxide category accounted for 14 percent of retail sales in the total disinfectant category, the highest share achieved in the United States since 2005.

Daily Disposable Lenses A survey of 227 Contact Lens Spectrum readers revealed that 52 percent of new fits and refits were with a silicone hydrogel material compared to 35 percent with hydrogels, with 12 percent of all soft lens refits and new fits in a daily disposable modality. This figure is similar to the 10 percent market share of daily disposables in the U.S. market compared to 33 percent worldwide mentioned previously. Figure 6 shows projections for 2008 as well. Cost is the most prohibitive factor for this modality in the United States, overshadowing its convenience and possible compliance and health benefits. Our reader survey indicates that 66 percent of respondents feel they will increase their daily disposable business in the next year.

Consumer data provided by CIBA indicates that 87 percent of Focus Dailies wearers are compliant with this modality, compared to 35 percent of total soft lens wearers. Our readers reported that about 22 percent of daily disposable wearers are compliant with the daily disposable modality and that 44 percent of two-week lens wearers are complaint with replacement schedules. However, they feel that only 8.5 percent of patients who require a lens care system are compliant with lens care instructions.

Our readers also see their toric and multifocal/bifocal businesses growing (58 percent and 71 percent, respectively).

Legislation

In April 2007 the Contact Lens Consumer Health Protection Act (CLCHPA), HR 2012, was introduced to the U.S. House of Representatives. The AOA is working with Representatives Mike Ross (DAR), Ed Whitfield (R-KY) and John Boozman, OD (R-AR) to build support for HR 2012. The CLCHPA seeks to amend the Fairness to Contact Lens Consumers Act (FCLCA) of 2004 to require all contact lens sellers to provide a toll-free phone number and dedicated e-mail address for the purpose of receiving communication from prescribers.

Figure 3. Current and projected silicone hydrogel revenue growth for the U.S. market.
Source: Company reports, Robert W. Baird & Co, Inc. estimates.

The bill stipulates that when a prescriber communicates a question or concern about the accuracy of a prescription to the seller, the seller must then obtain affirmative confirmation of the accuracy of the prescription before it's considered verified. The bill would allow prescribers to provide a seller with written notification stipulating the prescriber's preferred method of communication for contact lens prescription verification requests. It would mandate that no contact lens seller overfill a prescription for contact lenses, defined as providing more lenses than the prescription specifies or more lenses than the number required to fill a prescription for the period beginning on the date it's filled through its expiration date. It would also seek to impose stiff penalties on those who fail to comply with this bill.

1-800 Contacts ceased advocating legislation that supported consumer rights to fill contact lens prescriptions from the business of their choice after signing long-term supply agreements with CIBA Vision, CooperVision and Vistakon, its three largest suppliers. 1-800 had been purchasing directly from Bausch & Lomb since 2001.

In August the Federal Trade Commission (FTC) sent letters to 10 prescribers who failed to release contact lens prescriptions in accordance with the Contact Lens Rule of the FCLCA, following complaints filed with the FTC. Our reader survey also indicates that despite this federal legislation, only half of the respondents replied "yes, to every patient" when asked if they release contact lens prescriptions.

Mergers and Acquisitions

2007 proved to be a year of many mergers, acquisitions and partnerships. ABB Optical and Con-Cise took advantage of automation efficiencies and an enhanced ability to stock infrequently ordered lens parameters by merging operations to become ABB♦Con-Cise, the largest contact lens distributor in the United States.

Fenway Partners, a private equity firm, entered into a merger agreement with 1-800 Contacts. 1-800 sold its flat-pack technology to Menicon Co., Ltd., which is Japan's largest independent contact lens manufacturer. 1-800 sold its subsidiary ClearLab's manufacturing, distribution and customer support to Mi Gwang Contact Lens Co., a Korean based contact lens manufacturer.

Menicon partnered with UltraVision CLPL in the United Kingdom and Ireland for exclusive distribution of its new silicone hydrogel lens PremiO.

Figure 4. Modality breakdown for silicone hydrogel lenses in the U.S. in 2007. Source: Company reports, Robert W. Baird & Co, Inc. estimates.

Art Optical partnered with UltraVision CLPL for custom soft contact lenses and lathe cut soft contact lens technology.

On May 16, Bausch & Lomb entered into a merger agreement with private equity firm Warburg Pincus. Advanced Medical Optics entered the bid process, but withdrew its offer to purchase B&L on Aug. 1. Warburg Pincus completed the acquisition of B&L on Oct. 26.

Recalls

After seven non-serious complaints and no serious adverse events globally, CIBA Vision issued a letter to eyecare professionals on Jan. 12 detailing its voluntary recall of selected lots of O₂Optix contact lenses. The affected lenses fell below standard for ion permeability, which put wearers more at risk for persistent discomfort and superficial corneal staining. While CIBA Vision moved to implement manufacturing process improvements, significant back orders continued through the first half of the year.

In March, after three customer reports of discolored contact lens solution, Bausch & Lomb issued a limited and voluntary recall of 12 lots of its ReNu MultiPlus lens care solution because of an elevated level of trace iron. The iron in combination with other compounds could cause discoloration and a shortened shelf life.

Following Centers for Disease Control and Prevention data indicating that patients using AMO's Complete MoisturePlus had a seven times increased risk of developing Acanthamoeba keratitis (AK), AMO announced an immediate voluntary recall on May 25. In January the CDC initiated a retrospective survey of 22 ophthalmology centers nationwide to assess whether cases of AK were increasing in the United States. In March, data from 13 centers demonstrated an increase in culture-confirmed cases of AK with wide geographic distribution. No single lot number was repeated, suggesting that Complete Moisture-Plus was not intrinsically contaminated.

A multi-state investigation evaluated risk factors associated with the increase in AK cases. Of the 138 CDC reported cases from Jan. 1, 2005 to March 24, 2007, complete data was available for 46 cases. Of those 46 cases, 27 were female, 39 wore soft lenses, 16 reported swimming with their contact lenses and 35 reported showering while wearing their lenses. Of the 39 soft lens wearers, 56 percent reported using Complete MoisturePlus as their primary solution.

Charlotte Joslin, OD, and others looked at risk factors associated with 55 cases of AK in the Chicago area from May 1, 2003 to Sept. 15, 2006, and found that exclusive use of Complete MoisturePlus was independently associated with multivariate analysis. They also noted a pattern of risk associations such as solution re-use, lack of rubbing and showering while wearing contact lenses.

Figure 5. A.C. Nielsen data on solution market share through 2007. Does not include Wal-Mart or "club segments" but does include other mass merchandisers and grocers.

A large percentage of the AK cases are not associated with Complete MoisturePlus, prompting the industry and practitioners to once again consider patient compliance — or better yet, noncompliance — and the FDA standards for testing solutions. Interestingly, industry and survey data suggest that contact lens and lens care recalls have had almost no impact on practitioners' choice to fit contact lenses or to recommend multipurpose solutions. Use of hydrogen peroxide-based care systems is expected to grow somewhat, but some practitioners and patients still perceive these systems as less convenient. AMO is strongly recommending a rub-and-rinse step on each side of the lens and has released its new Complete Multi-Purpose Solution Easy Rub Formula with a global education campaign to educate contact lens wearers on proper lens care.

Eye on Innovations Survey

On the heels of this recall came the Eye on Innovations survey, conducted by the Contact Lens Council (CLC), a non-profit organization and educational resource sponsored by Alcon, AMO, B&L, CIBA Vision, CooperVision and Vistakon. The CLC surveyed 500 consumers between the ages of 18 and 65, along with a separate survey of 298 eyecare providers. The survey found that more than 44 percent of contact lens wearers always or sometimes top-off their contact lens solution. More than half reported not cleaning their lens case after each use despite 71 percent of eyecare provider respondents recommending it. Almost half of wearers reported not following recommended wear schedules.

Survey respondents were also unaware of major contact lens innovations, with 69 percent still unaware of silicone hydrogel materials, 55 percent unaware that some contact lenses protect against ultraviolet light, 40 percent unaware that multifocal contact lenses are available and 23 percent unaware that contact lenses to correct for astigmatism are available. More than 83 percent of the respondents would be interested in trying contact lenses if the lenses met their personal needs; most of those interested were unaware that contact lens options already exist to meet most visual needs. Due to this stunning gap in contact lens innovation and contact lens care knowledge, the CLC launched a new Web site to educate consumers at www.mycontactlenses.org.

Silicone Hydrogel Developments

The silicone hydrogel category had several additions in 2007. CIBA Vision introduced O₂Optix Custom, the first custom, lathe-cut silicone hydrogel lens available in sifilcon A material with a Dk/t at –3.00D of 117. The O₂Optix Custom lens is recommended for quarterly replacement and is available in sphere powers from +20.00D to –20.00D in three different diameters and 14 different base curves.

CooperVision launched its first silicone hydrogel lens, Biofinity, in June in the United States as a monthly replacement daily wear lens with 48 percent water content and featuring a high Dk/t of 160 with relatively low modulus. It's available in an 8.6mm base curve, 14.0mm diameter and sphere powers of –0.25D to –6.00D. Its material, comfilcon A, is nonsurface treated and maintains surface wettability through its combination and interaction of two silicone-based macromers and hydrophilic monomers, according to CooperVision.

Menicon, the fifth-largest contact lens manufacturer worldwide, launched PremiO, which is available only in the United Kingdom. It features an 8.3mm and an 8.6mm base curve, 14.0mm diameter, Dk/t of 161 and 40 percent water content. It's available in sphere powers from +2.00D to –7.00D as a two-week daily wear or one-week extended wear modality. According to Menicon, surface wettability is maintained through a patented polymerization system combining both plasma coating and plasma oxidation processes.

Figure 7 shows a graph of oxygen permeability versus water content for a variety of silicone hydrogel and hydrogel materials. This graph shows that both Biofinity and PremiO have a much higher oxygen permeability than what you might expect from their water content.

B&L introduced an 8.3mm base curve in the PureVision sphere line as well as a redesigned anterior surface for improved comfort. The company also adopted an improved manufacturing process, which decreased the modulus of the PureVision family of lenses by 28 percent. PureVision Toric parameters expanded to include hyperopic powers up to +6.00D and an increased cylinder power of –2.25D.

At the American Academy of Optometry meeting, Vistakon announced that Acuvue Oasys has joined CIBA Vision's Night & Day and Bausch & Lomb's PureVision as FDA-approved for therapeutic use as a bandage lens. It's approved for continuous wear as a therapeutic lens for up to six nights and seven days. Also, Vistakon's Acuvue Advance, Acuvue Advance for Astigmatism and Acuvue Oasys lenses became the first to receive the World Council of Optometry's Global Seal of Excellence for Ultraviolet Absorbing Contact Lenses.

Figure 6. Current and projected worldwide and U.S. daily disposable market share. Source: Company reports, Robert W. Baird & Co, Inc. estimates.

Hydrogel Lens Additions

CooperVision added to its PC hydrogel (omafilcon material) family of lenses. The Proclear 1-Day daily disposable features a handling tint, rounded edges and minus powers available up to –10.00D. The Biomedics EP is a two-week replacement multifocal for emerging presbyopes with add power up to +1.50D. Proclear Toric is now available with a –2.25DC in the 8.4mm base curve. CooperVision also added to its expanded parameter range of lenses, with the Proclear Toric XR offering cylinder powers up to –5.75D and the Proclear Multifocal XR available with sphere powers from +20.00D to –20.00 in 0.50D steps above ±6.50D and add powers up to +4.00D. The Proclear Multifocal Toric XR launched with sphere powers from +20.00D to –20.00D in 0.50D steps above ±6.50D, cylinder powers up to –5.75D and add powers up to +4.00D.

The daily disposable category received several additions. In addition to Proclear 1-Day, CooperVision added its ClearSight 1-Day daily disposable in ocufilcon B material that features an improved ergonomic blister pack for easier opening. CIBA Vision debuted its Focus Dailies Progressive with AquaRelease.

Hydrogel Vision Corporation introduced Extreme H₂O 54 percent Toric LC designed as an affordable toric option for low-cylinder patients (–0.50DC to –1.00DC). It's available in sphere powers of plano to –6.00D with a cylinder power of –0.65D and an axis range of 30 degrees to 180 degrees in 30-degree steps. Metro Optics expanded its SaturEyes product line with two new lathe cut options for presbyopic patients — the SaturEyes Multifocal and the SaturEyes Multifocal Toric, both offering add powers up to +2.50D.

Discontinuations

Several companies announced in 2007 that they would no longer make certain products for this year. Vistakon's Acuvue Toric, CooperVision's Biomedics 1-Day and Proclear Tailor Made Toric and Alcon's Unique pH solutions are all discontinued for 2008.

GP Lenses in 2007

B&L received FDA approval for its Boston XO₂ material that features a Dk of 141, available with or without UV blocking in diameters up to 21.0mm. It's indicated for myopia, hyperopia, astigmatism, presbyopia, daily wear orthokeratology and management of irregular corneal conditions.

Paragon Vision Science's Paragon HDS, Paragon Thin, Paragon HDS 100 and Fluoroperm (30, 60, 90 and 151) materials all received FDA approval for use in managing irregular corneal conditions. Likewise, Contamac received FDA clearance for its Optimum materials for the management of irregular corneal conditions.

Figure 7. Graph of oxygen permeability (Dk) versus water content (WC) for a variety of silicone hydrogels (green dots) and conventional HEMA-based lens materials (red dots). Both Biofinity and PremiO have a higher Dk than would be predicted from their WC.
Figure courtesy of Lyndon Jones, PhD, FCOptom, FAAO. Originally printed in October 2007 issue. Reprinted with permission.

Menicon launched Paragon Z-CRT in January with an average Dk/t of 97.2. Menifocal Z entered the U.S. market as a front-surface, center-distance, concentric presbyopic design available in Menicon Z material as a daily wear or 30-day continuous wear lens. Menicon's MeniCare GP lens care system became available in the United States, replacing the Claris products. It's recommended for hyper-Dk and plasma-treated materials.

AccuLens introduced its Clarity Plus Extended Add lens, an aspheric GP for advanced presbyopia. This dual aspheric design allows for correction of presbyopic prescriptions from +2.25D to +3.50D. ABBA Optical introduced its ABBA K_3, a unique diagnostic system for fitting keratoconus and corneal irregularities. The system features lens base curves ranging from 39.00D to 68.00D and diameters from 8.4mm to 13.5mm. Art Optical re-launched an improved Art Keratoconic System (AKS) with improved fitting charts and Optimum (Contamac) materials.

To facilitate GP lens fitting for practitioners, the CLMA's Gas Permeable Lens Institute (www.gpli.info) made available several educational tools in 2007, including a GP Lens Case Grand Rounds Troubleshooting Guide that launched with 52 separate cases ranging from spherical to irregular cornea fits and that will continue to be updated.

New Treatment for Corneal Ulcers

Vistakon Pharmaceuticals, LLC released Iquix (levofloxacin ophthalmic solution) 1.5%, approved for stand-alone therapy of corneal ulcers. The recommended dosing for days one through three is one to two drops in the affected eye every 30 minutes for two hours while awake and at four and six hours during sleep. Treatment from day four through completion is one to two drops every one to four hours while awake.

Corneal Staining Research

A study from Australia's Institute for Eye Research (IER) looked at solution-induced corneal staining (SICS) in 40 patients wearing each of 16 lens and solution combinations over three months of wear to evaluate the development of SICS over time. The IER Matrix Study, published in Contact Lens Spectrum in September 2007 and available at www.ier.org.au, challenges the much publicized "Staining Grid" research performed by Gary Andrasko, OD, MS, and further enhances the importance of SICS in comparing lens/solution combinations. We can't make direct comparisons between the two studies because the IER Matrix protocol consisted of looking for the presence of SICS three times over a three-month daily wear period and the Staining Grid assessed staining after two hours of wear and overnight soaking. Also, Andrasko reports the mean area of corneal staining whereas the IER Matrix reported the percentage of patients per month who developed SICS. The IER Matrix further defined SICS as diffuse punctate and peripheral annual staining to differentiate SICS from other types of staining.

The colors for the IER Matrix were chosen based on statistical analysis and the 4.9 percent overall rate of SICS with a 50 percent confidence interval of ±1.4 percent from 4.9 percent. Orange colored cells indicate rates above 6.3 percent, green cells indicate rates below 3.5 percent and yellow cells indicate rates in the middle two quartiles (3.5 percent to 6.3 percent). (Table 1). Table 2 shows a comparison of study results. Interestingly, ClearCare (CIBA) fared well in both studies while Opti-Free Express and Opti-Free Replenish (Alcon) both performed well in The Staining Grid but did not fare as well in the IER Matrix three-month study.

Company Litigation and Settlements

In August, B&L and Alcon settled a lawsuit pertaining to misleading promotional claims about ReNu MultiPlus made by Alcon in reference to the colorcoded Andrasko Staining Grid. Both companies agreed in a joint release that there is no evidence that the corneal staining observed by Dr. Andrasko increases the risk of corneal infection.

Alcon then challenged specific claims made by B&L with the National Advertising Division (NAD) of the Better Business Bureau. The NAD upheld that Alcon's Opti-Free Express is currently the #1 selling solution in the U.S. market, but B&L can state that ReNu MultiPlus together with its same formula sold as private-label store brands is the #1 selling solution in the United States. The NAD also concluded that B&L did not have sufficient evidence to state that ReNu MultiPlus "has been trusted by over 20 million contact lens wearers and their eyecare professionals."

CIBA Vision and CooperVision settled all global patent infringement lawsuits between the two companies. They have agreed to cross license rights to several patents with CooperVision paying a royalty on its U.S. net sales of Biofinity until 2014 and outside net sales until 2016. CIBA Vision has licensed two patent families from CooperVision related to contact lens designs.

CLEK Study

Wagner et al released the findings to date in Contact Lens and Anterior Eye (May 2007) of the eight-year multi-center, natural history study of 1,209 patients who have keratoconus from the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) study. The study coordinators concluded that clinicians can begin to envision the course of keratoconus and determine whether factors predictive of disease progression are present. At study entry 65 percent of participants wore GP contact lenses and 14 percent reported a family history of the disease.

Key findings included the following:

• Eight-year incidence of corneal scarring was 20 percent.
• NEI Visual Function Questionnaire suggests that the effect of keratoconus on vision-specific quality-of-life is disproportionate to its low prevalence and clinical severity.
• 19 percent experienced a decrease of 10 or more letters in high-contrast BCVA in at least one eye.
• 31 percent experienced a decrease of 10 or more letters in low-contrast BCVA in at least one eye.
• Subjects exhibited an average increase in corneal curvature of 1.60D in the flat corneal meridian with 24 percent demonstrating increases of 3.00D or more.

Continuous Wear Findings

Loretta Szczotka-Flynn, OD, MS, et al published the results of a 19-site study evaluating the cumulative probability and risk factors for developing corneal infiltrates in 317 wearers of continuous wear up to 30 nights with Night & Day (Archives of Ophthalmology, April 2007). Limbal redness and corneal staining may predict the subsequent development of an infiltrative event among 30-night CW patients. The probability of remaining free of any corneal infiltrates at one year was 94.3 percent, at the end of two years was 91.5 percent and at the end of three years was 89.7 percent.

First Global Meeting on Keratoconus

Contact Lens Spectrum and Lippincott, Williams & Wilkins Health Care Conference Group were proud hosts to the first international meeting dedicated to keratoconus fundamentals, insights, research, controversies, lens designs and surgical options. The Global Keratoconus Congress, held in Las Vegas in January 2007, was a huge success with 500 participants representing 30 countries and 100 sponsors from 31 companies. Response to the meeting was so favorable that a second GKC will be held this month from the 25th to the 27th and will feature hands-on workshops, 20 new speakers, post-surgical contact lens fitting and a session on irregular astigmatism.

Celebrating Life and Change

February 2007 marked Contact Lens Spectrum's celebration of the life of Neal Bailey, OD, PhD, founding editor of Contact Lens Spectrum, after his death in December 2006. Joe Barr, OD, MS, editor emeritus of Contact Lens Spectrum, often quotes Neal and often acknowledges Neal's guidance and teachings. Joe's contributions to Contact Lens Spectrum over 20 years kept it the leading contact lens-specific journal in the world.

My goal as the current editor is to ensure that our new team can live up to or exceed the high standard set by my mentor Joe and by his mentor Neal. CLS