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Article Date: 1/1/2005

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ANNUAL REPORT
2004 Annual Report
Contact Lens Spectrum
's annual report of major corporate and product developments and events in the contact lens industry in 2004, as well as predictions for 2005.
By Joseph T. Barr, OD, MS, FAAO

According to market statistics for 2004, the United States may have as many as 38 million contact lens wearers among approximately 125 million wearers worldwide. U.S. contact lens sales are increasing in unit digits from previous years. We expect low, single-unit growth of the market for wearers, but dollar growth will exceed this level of growth because of the slight premium price for new technology, which is well worth it for patients.

Too many eyeglass wearers are putting off their eye exams -- up to two years -- while practitioners see contact lens wearers about every 18 months. As many as eight of 10 contact lens wearers may sometimes sleep while wearing their contact lenses. This means we should recommend and prescribe higher-Dk/t lenses or we may find ourselves open to higher legal risk (not to mention that fitting such lenses results in happier, healthier patients who have better vision and appearance).

Most contact lens patients, if they wear the most recently developed lenses, wear them with greater eye health, comfort and vision than did previous wearers with previous lenses. Even though it's hard to believe, many practitioners will resist changing to newer lenses; but eventually patients will obtain new silicone hydrogel and aberration-correcting contact lenses.

Nearly two-thirds of our readers expect their silicone hydrogel and multifocal/bifocal business to increase in the next year, and a little more than half expect their daily disposable business to increase as well.

The industry mourned the loss of Gerald L. Feldman, PhD, and David J. Dougherty, both of whom developed the contact lens field in the late 20th century.

Modalities and Demographics

Table 1 shows that among new U.S. contact lens fits, 12 percent are fit in daily disposable lenses and 10 percent in continuous wear lenses. Daily and two-week replacement prescribing is increasing. Toric lenses account for about 17 percent of new fits and bifocal/multifocals account for about five percent.

A CIBA Vision survey of contact lens wearers found that:

  • Three-fourths preferred a schedule allowing some overnight wear.
  • 35 percent preferred a 30-day continuous wear schedule.
  • 14 percent preferred a one- to two-week extended wear schedule.
  • 20 percent preferred occasional overnight wear.
  • 27 percent preferred to remove lenses daily, with no overnight wear.

Bifocal contact lenses account for about 20 percent of all GPs manufactured, growing at a 25 percent annual rate. Ortho-k lenses grew at an eight percent annual rate in mid-2004.

According to Alcon, the field of wearers may prove more modest than our opening paragraph reports. Almost all soft contact lens consumers fall into one of three demographic segments:

  • 2.2 million teens, ages 13 years to 17 years
  • 13.2 million core consumers, ages 18 years to 34 years
  • 13.2 million baby boomers, ages 35 years to 64 years

The U.S soft contact lens wearer base remains fairly constant at 28.6 million. Although 2.8 million new wearers enter the U.S. market each year, roughly as many existing wearers drop out, primarily because of issues with wearing comfort.

Figure 1 (courtesy of Alcon) shows that new lens wearers equal the number of lens drop outs. Ten percent enter the market every year and 10 percent drop out. This is an alarming trend. It's obvious that current materials and solutions have room for improvement. At the time Alcon collected these data, more than 70 percent of lens wearers were wearing Group IV lenses and 70 percent of patients were using PHMB-based systems.

Figure 2 shows that lens wearer average age is increasing. Straight-lining the trend indicates that patients older than 35 years will make up the majority of wearers. That includes 35-year-old women, a demographic group that's particularly susceptible to "dry contact lenses."

One Company's 2003 Market Analysis

At the Southeastern Education Congress of Optometry meeting in late February in Atlanta, CIBA Vision reported that the global soft contact lens market enjoyed strong growth during 2003. According to Andrea Saia, president of CIBA's Global Lens Business, newer technology lenses that are increasing their market penetration and meeting more patient needs fueled this growth.

CIBA's report also noted that global soft lens manufacturer sales increased six percent in 2003, with the strongest worldwide growth in silicone hydrogel and daily disposable lenses. One- to two-week, monthly and specialty lens segments declined.

U.S. manufacturer sales were up seven percent in 2003, with similar growth in silicone hydrogel and daily disposable lens use. The current U.S. wearer base was 34 million at the time of CIBA's report, growing at a rate of two percent annually.

But 2003 also saw about 2.6 million dropouts who complained of discomfort, hassle and application/removal difficulties. CIBA predicts that continued lens innovation and awareness and use among patients of newer technology lenses will reduce the dropout rate to 2.1 million by 2008.

Finally, CIBA's report indicated that teens represented the largest age group of new entrants to the vision-correction market at 36 percent, followed by emerging presbyopes.

The Top 10 Issues in the CL Field in 2004

1. The contact lens field continues to grow primarily because of the prevalence of myopia.

2. The federal government enacted the Fairness to Contact Lens Consumers Act (FCLCA).

3. New silicone hydrogel lenses, which now include Vistakon's Acuvue Advance (Dk/t = 86) and CIBA Vision's addition of O2Optix (Dk/t = 138) to supplement its Night & Day (Dk/t = 175), became available. And in 2005, Bausch & Lomb's PureVision (Dk/t = 110) will return. (For reference, 125 Dk/t = no anoxia on average; 90 Dk/t = no hypoxic stress on average; 85 Dk/t = no excessive overnight swelling on average. For comparison, Acuvue 2 Dk/t = 26.)

Figure 1. Courtesy of Alcon.

Figure 2. Courtesy of Alcon.

4. New contact lens solutions became available. Bausch & Lomb released ReNu with MoistureLoc (which contains Poloxamer 407, poloxamine, hydrantate and polyquaternium 10, as well as Alexidine [a biguanide] to control deposits, help retain moisture and provide disinfection), claiming it "creates a cushion around lenses that retains moisture and keeps irritating deposits off." CIBA Vision launched its Aquify 5 Minute Multi-Purpose Solution.

5. CooperVision, Inc. announced its acquisition of Ocular Sciences, Inc. in September, making the combined CooperVision/OSI the third largest contact lens manufacturer. The company plans to further develop the silicone hydrogel material by leveraging its Proclear phosphorylcholine material. The company is also emphasizing its Proclear Toric and Proclear Multifocal lenses.

6. Corneal Refractive Therapy and B&L's new Vision Shaping Treatment (approved in 2004) are growing slowly but surely. The fee is a factor, but practitioners who can communicate the benefits as well as the risks are steadily using this treatment.

7. Dryness in contact lens wear (whatever that means) matters, and companies have developed new eye drops and contact lens lubricants to combat it. Advanced Medical Optics introduced blink Contacts containing 0.15 percent hyaluronate, which AMO claims prolongs tear break-up time and provides longer-lasting moisture to the lens and the eye. CIBA Vision released Aquify, which contains Dexpant-5 (an ingredient found in dry-eye and wound-healing products) and Sorbitol, a humectant.

8. The differential diagnosis of corneal complications was a hot topic, and we offer the following scheme:

  • High probability of microbial keratitis (MK) = 1+ infiltrates >2mm and anterior chamber reaction or pain or mucopurulent discharge or positive culture. Scar with follow up.
  • High probability of infiltrative keratitis, etiology indeterminate = 1+ infiltrates with signs/symptoms not clearly meeting MK or sterile keratitis.
  • High probability of sterile keratitis = 1+ infiltrates <1mm, outside of the 6mm central zone and min AC Rxn and no mucopurulent discharge and mild pain (Bullimore, personal communication). At year's end, silicone hydrogel corneal ulcer rates appeared to approach those of low-Dk lenses, but they weren't as severe in terms of affecting vision.

9. During the Halloween season, the FDA issued consumer warnings about the risk of using decorative contact lenses distributed without appropriate involvement by an eyecare professional. The FDA claims that it has received reports of corneal ulcers associated with the wearing of decorative contact lenses. Other risks include conjunctivitis, corneal edema, allergic reaction and corneal abrasion resulting from poor lens fit. This kind of unsupervised lens wear can also result in reduced visual acuity, contrast sensitivity and other visual functions. "Consumers should understand that decorative contact lenses, like contact lenses intended for correcting vision, present serious risks to eye health if they are distributed without the appropriate involvement of a qualified eyecare professional," warns Dr. Lester M. Crawford, acting FDA commissioner. This warning applies not only to the Halloween season, but to all times of the year.

10. B&L and CIBA Vision settled lawsuits to allow the return of B&L's PureVision to the market in mid April 2005. B&L filed a lawsuit against OSI over OSI's Biomedics Toric lens. OSI denied the lens design infringed the B&L patent.

Notable 2004 Events

  • Menicon added numerous distributors.
  • Contamac and Lobob announced the collaborative marketing of Contamac's Optimum line of GP materials and Lobob's Optimum solutions. Contamac offers four GP materials ranging from 26 Dk to 125 Dk.
  • The March issue of the journal Ophthalmology discussed six children aged nine years to 14 years who developed corneal ulcers associated with overnight orthokeratology during the period from March 1999 to June 2001. (The article didn't mention what lens materials the fitters used).
  • In early 2004, Vistakon opened its Vision Care Institute, where instructors are currently training optometry students in specialty disposable contact lens fitting and patient communication. The Institute also features the "exam room of the future," supplied by Marco Technologies.
  • Paragon held a symposium on corneal reshaping in June and founded the American and International Societies of Refractive Therapy (ASCRT).
  • 1-800 Contacts acquired Vision Tec, a manufacturer of low-cost disposable lenses. 1-800 has also acquired a number of 510K approvals for contact lenses, and some industry observers wouldn't be surprised if the mail-order giant started to manufacture and sell its own lens brand and even attempt to obtain approval for a generic equivalent hydrogel lens.
  • OSI launched gotlenses.com, a Web site to which practitioners can direct their patients for purchasing contact lenses. Each OSI account can set its own fees and receive reimbursement for its patients' purchases at this site.
  • The federal government issued the FCLCA on February 4, 2004, and the act took full effect in August. As the year went by, difficult-to-manage voice mail messages from less-than-genuine, unlicensed suppliers upset many practitioners as they struggled to verify prescriptions. We still need to know if a seller sold lenses to our patients and how many. Fortunately, this act hasn't adversely affected our practices, and most patients most of the time still buy their lenses from their prescriber. Also, many patients who have expired prescriptions have returned for eye exams as a result of not having an updated prescription.
  • In May, Rose K International named Blanchard Contact Lens of Manchester, NH and Les Laboratoires Blanchard in Quebec as its new master distributor, while Lens Dynamics, the former Rose K distributor, launched its Dyna Z Intralimbal lens that incorporates the Menicon Z material.
  • 1-800 Contacts needed to cancel more than $10 million in contact lens wholesale orders because of what they described as the unfair advantage of contact lens practitioners acting as both the prescriber and seller. Vistakon's tough policy on 1-800's prescription verification processes probably also contributed. In related news, 1-800 expanded its alliance with Cole Managed Vision, and Luxottica acquired Cole National.
  • CooperVision uncovered contaminated, counterfeit ProClear lenses in the United States after battling counterfeit product problems in Europe in February 2004. The company became aware of the problem after two patients complained to CooperVision about the quality of their ProClear Compatibles lenses. One of the patients returned the suspect lenses to the company, and subsequent analysis determined they were counterfeit. CooperVision believes the product to have come from 1-800 Contacts, and both Cooper and 1-800 are working with the FDA to monitor and correct the situation.
  • In Toronto in July, 620 people from 32 countries met at the Global Orthokeratology Symposium (GOS) to learn about basic, intermediate and advanced clinical practice methods and research relative to corneal reshaping. From central epithelial thinning with myopic corneal refractive treatment to epithelial thickening with hyperopic treatment to stromal changes to interpretation of corneal topography to Dr. John Mountford's new book, the attendees found the 2004 version of GOS as exciting as the first 2002 meeting. Stuart Grant received the GOS Founders Award for his pioneering work in ortho-k. (Contact Lens Spectrum and Boucher Communications' Healthcare Conference Group sponsor the GOS.)
  • The results of the Contact Lenses and Myopia Progression (CLAMP) study published in mid December after a three-year trial. The CLAMP authors found that the GP wearers' myopia progressed less than that of the soft lens wearers, but not enough to indicate that practitioners should prescribe GP lenses primarily for myopia control.

2004 Product News

  • CooperVision recently introduced the Proclear Multifocal, which combines PC Technology and Balanced Progressive Technology. According to the company, this combination creates a premium soft multifocal lens that provides all-day comfort, visual acuity at every distance and the flexibility to fit virtually all of your presbyopes. CooperVision has also now fully integrated UltraVue 2000 into the product portfolio with Cooper's Balanced Progressive Technology lens fitting system.
  • In June, the FDA approved Euclid Systems Corporation's Emerald and C&E GP Specialists' Fargo and GP Express (overnight) orthokeratology lenses. The FDA later approved numerous other lenses that use Bausch & Lomb/Polymer Technology materials under the umbrella of Vision Shaping Treatment.
  • Additions Technology received FDA approval in the form of Humanitarian Device Exemption for using Intacs to treat keratoconus.
  • Optical Connection, Inc. formed an alliance with Ophthonix, Inc. to develop WaveTouch Process wavefront-corrected contact lenses using the Z-View aberrometer. Optical Connection will introduce the iZone by Definition FRP lenses this quarter. The SynergEyes hybrid lens from Quarter Lambda Technologies, Inc. may debut in 2005 with a Paragon HDS 100 GP center, 31 percent water skirt and 14.5mm diameter. The company will also use the 8.2mm rigid center in non-rotating designs for torics and will develop a multifocal lens that incorporates wavefront correction.
  • The Lagado Corporation introduced its Onsi-56 rigid lens, (onsifocon A), which it refers to as a rigid "silicone hydrogel" lens, in many designs.
  • In 2005, CIBA Vision will offer CSI FW sphere, toric and Durasoft 2 optifit and D-3 optifit toric only on a made-to-order basis and shipped within 10 days of order.

 TABLE 1CL Spectrum Readers Fits/Refits by Category (N=144)

Conventional 6
Disposable two-week 46
Planned Replacement 26
(one month to three months)
Daily Disposable 12
30-day Continuous Wear 10

Glancing Ahead

This past year was one of the most innovative in a long time, with silicone hydrogel lenses making great strides and gaining a foothold that will make them the future lenses of choice, especially with their reasonable price. Acuvue Advance became the second most prescribed lens in the United States next to Acuvue 2, which shows that practitioners no longer use silicone hydrogels primarily for extended/continuous wear. O2Optix continued this trend. These new lenses may help reduce dropouts.

Overnight ortho-k and established CRT will grow slowly if no major issues with children occur. Specialty high Dk/t lenses will soon be available. More competition between companies will be good for everyone. Refractive surgery of all types will compete, but not for the majority of patients. Finally, new lens care and accessory solution and drug products will improve contact lens wear.

Dr. Barr is editor of Contact Lens Spectrum magazine. He's a professor and associate dean for clinical services and professional program at The Ohio State University College of Optometry.

 

 

 

A Summary of the CL Industry in 2004
by Jeffrey D. Johnson, OD, Associate Analyst -- Medical Technology, Robert W. Baird & Co., Inc.

 

In the United States, several positive trends that began to develop over the past few years continued to play out in 2004, including solid growth in the specialty soft contact lens categories. Disposable soft toric contact lenses continued to drive a significant portion of the growth in this category, and increasing use of soft disposable multifocal contact lenses meaningfully contributed to industry-wide performance for the first time this year as well. Overall, we estimate the U.S. soft contact lens market likely grew upwards of eight percent to nine percent in 2004, an improvement over the seven percent to eight percent growth recorded in 2002 and 2003 and what we estimate was an essentially flat (to slightly down) domestic market in 2000 and 2001.

The domestic soft disposable toric contact lens market likely grew approximately 15 percent (at the manufacturer level) in 2004, with Ocular Sciences and Cooper Companies likely generating the highest growth rates in this segment at approximately 40 percent and 30 percent respectively. Bausch & Lomb, which dominates the two-week disposable toric contact lens category in the United States with an estimated 40+ percent share, grew sales in this category essentially in-line with the market (at roughly 15 percent), while Vistakon (with an estimated 20 percent share of the disposable toric lens market) likely grew its disposable toric lens sales slightly below the 15 percent market rate.

The use of soft multifocal contact lenses increased significantly in the United States during 2004 as well (we estimate this category likely grew 60+ percent in 2004, to an estimated $70 million at the manufacturer level), driven primarily by a nearly doubling in sales of Bausch & Lomb's SofLens Multifocal. Overall, we estimate Bausch & Lomb now controls approximately 40 percent to 45 percent of the U.S. disposable multifocal contact lens market, with annual domestic sales in the $30+ million range. Additionally, we believe Cooper's multifocal contact lens sales likely grew in the 40 percent to 45 percent range during the year, driven by growth in the company's Frequency 55 multifocal lens line as well as the introduction of Proclear Multifocal contact lenses. We estimate sales of Vistakon's Acuvue Bifocal and CIBA's Focus Progressives were up only slightly in 2004 (with Vistakon and CIBA controlling an estimated 30 percent to 35 percent and 10 percent to 15 percent share of the 2004 domestic soft multifocal market respectively).

We believe that although the allure of continuous wear has driven much of the early growth in silicone hydrogel contact lens use in recent years, the secondary advantages that these lenses appear to provide (reduced redness, itching and dryness or discomfort that can result from oxygen deprivation in lower Dk/t contact lenses) may offer even greater long-term growth opportunities. Given silicone hydrogels' potential to provide improved comfort characteristics, we believe many doctors will eventually begin to advocate these lenses for a majority of their patients, not just those who wish to sleep in their lenses. And as doctor and patient demand for silicone hydrogel lenses grows, we expect manufacturers to respond with increased options, including toric (Night & Day toric lenses are currently available in the United States, while we expect PureVision toric lenses to launch in May 2005) and multifocal designs.

Finally, given the tangible benefits that silicone hydrogel lenses provide (improved health and comfort profiles), both manufacturers and doctors have thus far charged premium prices for these lenses (Acuvue Advance and O2OPTIX both entered the market at price points approximately 20 percent above standard two-week disposable spherical lens prices). Combining this positive pricing environment with a projected favorable mix-shift to specialty lenses, we look for contact lens industry-wide growth trends to remain solid over the next several years.

 


Contact Lens Spectrum, Issue: January 2005

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