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ANNUAL REPORT
Contact
Lenses 2006
By Joseph T. Barr, OD, MS, FAAO, & the
editorial staff of Contact Lens Spectrum
CLS
reviews the major industry developments of 2006, including contact lens profitability,
the re-emergence of lens care and controversial contact lens legislation.
The
U.S. contact lens market grew by 11.5 percent at the retail level in the first half
of 2006, according to Baird U.S. Equity Research. Spherical silicone hydrogel lens
sales increased more than 50 percent, with an accompanying 10 percent decrease in
hydrogel lens sales overall. Silicone hydrogels in the first half of 2006 accounted
for 37 percent of retail contact lens sales. We expect the contact lens market to
grow at a rate of nearly 8 percent in the next few years.
Worldwide market share for soft contact lenses
is approximately 42 percent for Vistakon/Johnson & Johnson Vision Care, Inc.,
22 percent for CIBA Vision, 17 percent for CooperVision and 16.5 percent for Bausch
& Lomb.
At
the manufacturer level, the worldwide contact lens market is about $4.56 billion
with about $3.3 billion in spherical lens sales and $1.26 billion in specialty
lens sales. GP lenses add another $250 million in sales.
Lens Dispensing Trends
According to our Contact Lens Spectrum
Reader Profile Survey from February 2006, our readers who responded estimated that
they fit and refit lenses on their patients as indicated in Table 1.
Interestingly, of those who responded, 30
percent dispensed no silicone hydrogel lenses, 23 percent dispensed no daily disposable
lenses and 27 percent dispensed no lenses for extended wear. It seems we still prescribe
too few daily disposable lenses in the United States compared to Europe and Japan.
Perhaps the new moisture loaded lenses will help.
We also asked in the survey, "What
lens modality do you see increasing?" Seventy-two percent responded silicone hydrogel
lenses, 60 percent said torics and 67 percent said bifocal and multifocal lenses.
The article "International Contact
Lens Prescribing in 2006" by Philip Morgan, PhD, MCOptom, et al beginning on p.
34 describes prescribing trends from 19 countries in 2006.
In October 2006 we asked readers of
Contact Lenses Today (www.cltoday.com) about their usage of silicone hydrogel
contact lenses. Eighty-two percent (n= more than 125) said silicone hydrogels were
their modality of choice, with Acuvue Oasys (Vistakon) and O2Optix (CIBA
Vision) their top choices. Seventy-five percent said they were fitting spherical
silicone hydrogels first on new fits. These percentages hold up for happy patients
who are refits as well as for symptomatic refit patients.
Contact Lenses Are Profitable
Euromcontact (an industry group comprised of the
European arms of Allergan, B&L, CIBA, Essilor and J&J) sponsored a study
in 2001 at the The London Business School under the leadership of Professor Mark
Ritson, an award-winning marketing expert and researcher. The group asked Dr. Ritson
to independently (he could publish the results no matter what the outcome) determine
if contact lens patients were more profitable than spectacle-only patients. As with
previous studies we've published from the United States and Australia, Dr. Ritson's
team did find, in five European countries, that indeed contact lens patients are
more profitable than are spectacle patients. Contact Lens Spectrum published
the results of this study in March 2006 in collaboration with Vistakon following
a presentation on this and related studies at SECO in February. A Contact Lens
Spectrum CD-ROM capturing the SECO presentation, the full text of the study
results and insights from key opinion leaders on how to more effectively communicate
with patients about contact lenses is available from Vistakon.
Management Methods Need Improvement
On the other hand, an ongoing survey conducted
by the Management & Business Academy (MBA) shows the majority of independent
ODs do not adopt many of the "best practices" recommended by leading consultants
to improve financial performance.
The MBA is a professional education initiative
launched by CIBA Vision and Essilor of America in 2005. Its database includes information
on nearly 500 of the largest practices in the country. The survey shows:
• Financial management is a weakness
for most independent ODs. Only 21 percent develop a written annual budget and 47
percent don't define annual revenue goals. Only 14 percent of respondents said they're
"very satisfied" with the net return of their practice.
• Most independent ODs spend little
for marketing and promotion, with a median of only 1.2 percent of gross revenue
spent on marketing. About 77 percent of practices have a Web site, but 74 percent
update it infrequently.
• Independent ODs say staff management
is their biggest challenge, with average annual staff turnover at 17 percent, meaning
about one in six employees leaves the practice a year. Half of owners don't regularly
share financial performance data with the staff, and 89 percent have not developed
written qualifications for each position. A little more than half of practices do
not provide annual written performance appraisals, and 33 percent conduct infrequent
staff meetings — quarterly or less often.
The MBA has a repository of staff management
tools and guidelines available free of charge at http://www.mba-ce.com.
Lens Care
Like never before, 2006 was the year of lens care.
Not just because of the unprecedented worldwide withdrawal of a multipurpose solution
— Bausch & Lomb's ReNu with MoistureLoc (see sidebar on p. 31) — but
because of the aggressive marketing of other new products, especially those designed
to be compatible with silicone hydrogel as well as hydrogel lenses such as Alcon's
Opti-Free Replenish. All this while the most widely used products in the market
are the plethora of private label — some would say obsolete — products
(Table 2).
The rash of Fusarium keratitis cases
related in part to improper use of B&L's ReNu with MoistureLoc also prompted
renewed patient interest in the importance of lens care procedures and compliance.
In other lens care news, CIBA introduced
the ProGuard lens case available with Aquify Multi-Purpose Solution. The case is
infused with silver ions to kill bacteria and minimize contamination. Although CIBA
had closed down a plant in Canada, it has come back on line and CIBA is again supplying
its lens care products on a regular basis.
J&J announced that it saw opportunity
in the lens care market and has a team working on the initiative.
Throughout 2006, Alcon presented information
about superficial corneal epithelial fluorescein staining associated with lens care
products and various contact lens materials, and more so with products that contain
PHMB. These data, compiled by Gary Andrasko, OD, are available at www.staininggrid.com.
Inyx Inc., a specialty pharmaceutical
company, acquired six over-the-counter eyecare products from Advanced Medical Optics
(AMO): Lens Plus Aerosol, Lens Plus Rewetter drops, Lens Plus daily cleaner, LC-65
daily contact lens cleaner, Hydrocare fizzy tablets and Total solution. Exaeris,
Inyx's marketing subsidiary, will take over established customer relationships.
Sauflon USA introduced its One-Step
system, a preservative-free, hydrogen peroxide-based lens care system available
exclusively to eyecare professionals.
Contact Lens Events and Innovations
Silicone Hydrogels The results
of the CIBA Vision extended/continuous wear, FDA-required, post-market surveillance
study with the company's Night & Day lenses indicated an overall microbial keratitis
(MK) incidence of approximately 0.18 percent (similar to previous studies with extended
wear hydrogel lenses) and visual acuity loss of <0.04 percent. Late in 2006,
a New Zealand study indicated that silicone hydrogel wearers had shorter MK duration,
but a rate of vision loss and cost equal to hydrogel wearers.
The AOA's Commission on Ophthalmic Standards
has given its Seal of Acceptance for Ultraviolet Absorbing contact lenses to Vistakon's
Acuvue Advance and Oasys brand contact lenses. The AOA specifications are in line
with the standards of the American National Standards Institute (ANSI) and International
Standards Organization (ISO). The ANSI and ISO classify UV-blocking contact lenses
into two groups based on the lens' absorptive capacity at minimum thickness. Vistakon
says the Acuvue brands are the only lenses to achieve Class I UV-blocking status,
which indicates that they absorb a minimum of 90 percent of UVA and at least 99
percent of UVB radiation.
CooperVision
will soon distribute its new silicone hydrogel lens Biofinity, a 48-percent-water-content
lens with a Dk/t of 160, for daily wear while it undergoes testing for extended
wear.
CIBA's O2Optix Toric
for Astigmatism lenses were available on a limited basis in some practices in 2006.
O2Optix Custom lenses in sifilcon A material, with a Dk/t of 82 at –3.00D
and power range of ±20.00D, will soon be available in lathe-cut, made-to-order
designs (two-week delivery) for daily wear, quarterly replacement, available in
four packs. (See Product Spectrum on p. 51.)
B&L launched its PureVision Multi-Focal
contact lenses for presbyopia. The lens combines the company's SofLens Multi-Focal
design with enhanced aspheric optics on the anterior surface of the lens. PureVision
is approved for daily or extended wear up to 30 days and is intended for monthly
replacement.
Hydrogels Vistakon introduced
its 1•Day Acuvue Moist lens. The new lens incorporates Lacreon technology,
which employs a unique process that permanently embeds the water-holding ingredient
PVP — similar to that found in natural tears — into the etafilcon material.
The FDA has cleared the lenses for use in patients who suffer symptoms associated
with ocular allergies during contact lens wear.
Biomedics XC and Proclear Multifocal
Toric are CooperVision's latest addition to its PC Hydrogel (omafilcon) family of
lenses. CooperVision also offers two daily disposable products that feature UV blocking
(Biomedics 1-Day and ClearSight 1-Day) and will introduce a Proclear 1-Day lens
in omafilcon A, featuring CooperVision's Aberration Neutralising aspheric optics,
this month (see Product Spectrum on p. 51 for more details).
Hydrogel Vision Corp. introduced the
Extreme H2O 54% lens (hioxifilcon D) in a material featuring a new GMA-HEMA
copolymer. The company's previous lens had a water content of 59 percent.
CIBA introduced its FreshLook One-Day
color contact lenses. The company says the lenses are designed for patients who
would like to wear colored lenses from time to time. They are available in the four
most popular FreshLook ColorBlends colors: pure hazel, blue, green and gray. The
company also introduced Focus Dailies with AquaRelease, a new daily disposable lens
that features a built-in moisturizing agent for improved end-of-day comfort compared
to Focus Dailies. AquaRelease is released from the lens into the tear film with
each blink.
Unilens Vision Inc. announced the C•Vue
Aspheric single-vision, two-week disposable soft contact lens for daily wear. The
new lens features wavefront technology for aberration control.
The Ocu-Ease Elite from Ocu-Ease Optical
is made of methafilcon A. It's a disposable lens with a visibility tint, available
in six packs. The lens is available exclusively to eyecare practitioners.
Imperial Optical entered into an agreement
with Strategic Lens Innovations to market and distribute the Solus brand family
of contact lenses in the United States. Lenses include the Solus TCL, a custom,
toric lens; the Solus 55a, an aspheric, one- to two-week disposable, UV-blocking
soft lens; the Solus Soft K (a soft keratoconus lens). The Solus Platinum line,
made with Hioxyfilcon, will be introduced as well. The company's agreement with
Strategic Lens Innovations prevents the restriction of sales only to independent
eyecare channels. However, Imperial Optical is holding true to its single-tiered
pricing structure so independent eyecare professionals pay the same price as buying
groups, retail chains and wholesale clubs.
Sauflon USA introduced the Sauflon
55 UV Aspheric, which features an aspheric front surface and UVA/UVB protective
material. The company says its Advanced Edge Design manufacturing process ensures
all day comfort and improves lens handling.
PolyVue Distribution, Inc. launched
its HDX Toric Progressive lens, which the company says is the first fully molded,
planned replacement toric progressive contact lens. It also incorporates aberration-control
optics.
SpecialEyes, LLC now offers its 59
Toric soft contact lens, a custom lens that the company says offers a personalized
fit and standard four-day delivery.
1-800 Contacts and ClearLab may introduce
AquaSoft Singles in future years. Clear Lab, a wholly owned subsidiary of 1-800
Contacts, has announced the potential of its new AquaSoft Singles, an innovative
flat pack for contact lenses. The new packs are 1mm thick and are color-coded to
make it easier for patients to distinguish the right lens from the left. The lens
is compressed to fit into the pack and packaged with the inside of the lens facing
down. When patients peel back the foil, the lens presents with the outside of the
lens facing up, so that patients don't have to touch the inside of the lens. The
lenses will also be marked R and L for right and left eyes and the prescribing doctor's
name will appear on the package.
GP Lenses The U.S. Food
and Drug Administration (FDA) approved an expanded indication for B&L's Boston
XO (hexafocon A), Boston EO (enflufocon B) and Boston ES (enflufocon A) GP lens
materials for use in post-surgical situations. Practitioners can now prescribe lenses
in these materials for non-diseased eyes that require a GP lens to manage irregular
corneal conditions or following penetrating keratoplasty or refractive surgery.
Lens Dynamics, Inc. introduced its
new Dyna Z Cone Plus lenses for irregular corneal conditions. New features include
larger back optical zones to reduce glare, increased and decreased edge configurations,
a standard peripheral system to accommodate more corneas and a flat/steep option
that allows you to correct the standoff at 6 o'clock, according to the manufacturer.
Blanchard Contact Lens, Inc.'s new
Rose K2 contact lens for keratoconus incorporates aberration control, which the
company says dramatically reduces flare, glare and ghosting and improves visual
acuity up to two lines. Rose K2 is available in Boston XO material. Blanchard also
launched the Rose K IC Lens, a large-diameter, specialty GP lens for irregular cornea
applications. The lenses are manufactured with a larger posterior optical zone than
standard lenses; an aspheric, posterior-surface, aberration-control optic; and reverse
geometry paracentral fitting curves. Primary applications include pellucid marginal
degeneration, globus cones, post-graft and LASIK-induced ectasia with secondary
applications for nipple and oval cones.
The FDA granted approval for SynergEyes,
Inc. to market its SynergEyes PS hybrid contact lens for daily wear in the correction
of post-surgical and post-traumatic refractive errors. It also introduced the SynergEyes
A (for regular ametropias) and SynergEyes KC for keratoconus and plans the SynergEyes
M for presbyopes. SynergEyes received FDA clearance for use with Opti-Free Replenish.
The Public Broadcasting Service (PBS)
ran a mini-documentary on GP lenses as part of an effort to educate viewers on often-unknown
topics of interest. The documentary, Spotlight On: Vision, featured interviews
with Bruce Anderson, OD, Ed Bennett, OD, Walter Choate, OD, and Wiley Curtis, OD.
It focused on the role that GPs play in improving vision and included segments on
corneal reshaping, lenses for presbyopia and advances in GP technology. To assist
ODs in anticipated patient inquiries on the movie, the Contact Lens Manufacturers
Association (CLMA) made the program available on DVD through CLMA member labs. It's
also available on the association's Web site at www.contactlenses.org.
The CLMA also offers eyecare practitioners
a free copy of a recent PBS broadcast that investigated and explored contact lens
myths. The video addresses commonly held myths about vision and informs patients
how specialty contact lenses can address their unique needs with options such as
overnight contact lens corneal reshaping, GP lenses and multifocal contact lenses
for presbyopia. It also explains the long-term comfort and advantages of GP lenses.
Visit www.gpli.info to request a free copy.
NKL B.V., the largest GP manufacturer
in the Netherlands, entered into a strategic, long-term alliance with Menicon Co.,
Ltd. The companies agreed to collaborate in all areas of global operations including
R&D, manufacturing, logistics, marketing and sales. As a result, NKL will begin
to manufacture contact lenses in Menicon's materials and distribute both Menicon
lenses and lens care products in the Dutch market. Menicon will distribute NKL's
contact lenses through is European subsidiaries in France, Germany, Spain and the
United Kingdom. Menicon is launching Menifocal, its Menicon Z material lens for
presbyopia, and the company obtained FDA approval for Menicon Z CRT in the United
States and will market its Menicon Z lens in Japan for 30-day continuous wear. It
will also sell MeniCare GP solutions preserved with benzyl alcohol (see Product
Spectrum on p. 51 for more details).
Accu Lens Inc. launched its Clarity
Plus dual aspheric GP multifocal contact lens with up to +2.50D add. The company
also offers the Aqua-Wet Plasma Treatment for GP lenses.
Valley Contax became the exclusive
manufacturer and distributor of the I Kone keratoconus lens designed by Rob Breece,
OD. The lens features a bi-aspheric design and larger overall diameter.
ABBA Optical now offers its ABBAKone
keratoconus lens in a new 26-lens fitting system. The company is also launching
its ABBA K_3 diagnostic system for keratoconus and other corneal irregularities
this month (see Product Spectrum on p. 51 for more information).
Aero Contact Lens, Inc. added Aspirations
and Aspirations Plus back-surface, low-eccentricity multifocal lenses to its presbyopic
options.
On the Legal Side
2006 was a year of much activity in the area of
contact lens legislation and its enforcement. Following are the highlights.
Enforcement of Contact Lens Rule
• On June 27, the Federal Trade
Commission (FTC) sent 18 warning letters to online retailers of cosmetic or colored
contact lenses. According to the FTC, most had claims on the company Web site that
cosmetic lenses are non-prescription or do not require a prescription. The FTC also
notes that most of these retailers may not be verifying prescriptions.
The FTC also has issued, "The Contact
Lens Rule: A Guide for Prescribers and Sellers," to educate contact lens prescribers
and sellers about their obligations under the Contact Lens Rule and, "The Eyes Have
It — Get Your Prescription," to educate contact lens consumers about their
rights.
• On Aug. 7th, FTC filed charges
against Walsh Optical Inc. and its owner Kevin Walsh for violating the Fairness
to Contact Lens Consumers Act (FCLCA) of 2003 and the Contact Lens Rule of 2004.
Walsh Optical operates three Web sites that sell contact lenses directly to consumers.
The FTC alleges that the sites failed to verify consumers' prescriptions. The company
is settling charges and will pay $40,000 in civil penalties.
New and Pending Contact Lens
Legislation
• The Utah Senate Bill 176, The
Contact Lens Consumer Protection Act, passed on Feb. 20th. Beginning July 1st, the
new legislation required manufacturers doing business in the state to certify with
the attorney general that their lenses are "made available in a commercially reasonable
manner," to alternative channels of distribution, defined as any mail-order company,
Internet retailer, pharmacy, buying club, department store or mass merchandise outlet.
Exempt from the law are GPs, lenses for keratoconus and custom lenses. Manufacturers
that knowingly and intentionally violate the law will be guilty of a class-A misdemeanor.
As a direct result of this legislation,
Hydrogel Vision Corp. stopped doing business in Utah in July, rather than lose control
of distribution of its Extreme H2O lenses. Steven T. Schuster, president
of the company, said he considered the requirements unreasonable. "We consider that
the alternative channels designated in Utah are not the equal of eyecare professionals
when it comes to the critical issue of patient care and follow-up," he said. Kevin
McCallum, Senior Vice President of Marketing and Operations for Utah–based
1-800 Contacts, responded that Hydrogel's decision raises questions about its lenses
and whether the company believes it could effectively compete in a market where
lenses are sold on medical merits alone.
• In March, CooperVision retained
legal council and lobbyists as part of an intensive lobbying campaign to defeat
the contact lens legislation proposed by 1-800 Contacts in various states. In a
press release, the company said the language of the legislation is ambiguous and
does not define standards such as "commercially reasonable" and "nondiscriminatory
manner."
• On the federal level, in early
April Senators Robert Bennett (R-Utah) and Patrick Leahy (D-Vt.) introduced S. 2480,
The Contact Lens Consumer Protection Act (introduced in Congress as H.R. 5762),
which seeks to amend the Fairness to Contact Lens Consumer Act (FCLCA) to include
restrictions on manufacturer distribution policies. The language is similar to the
legislation that passed in the state of Utah and would require manufacturers to
make contact lenses available to alternate channels of distribution. The federal
bill also included a Safe Harbor for manufacturers.
Congress rejected a similar bill by
Sen. Bennett in 2005 after the AOA and others voiced concern. Similar state bills
in six other states were also rejected or blocked in 2006.
The Senate Finance Committee considered
S. 2480 in late June despite an FTC report that found no major problem with consumer
access. In a joint letter, the American Optometric Association and the American
Academy of Ophthalmology said the biggest problem with the new law is passive verification.
The American Medical Association (AMA) House of Delegates passed a resolution calling
on Congress to remove the existing passive verification subsection of the law altogether.
Mr. McCallum responded, "The AAO and
AOA are seeking an unprecedented doctor-pharmacy system where the doctor is allowed
to own their own pharmacy and compete with anyone else attempting to fill the prescription."
He further explains that Congress adopted the passive verification system to address
that conflict of interests, while still allowing eye doctors to sell to patients.
Mr. McCallum also notes the Committee reported an, "unusually high number of consumer
complaints in states that rely on active verification schemes," and that the "passive
verification system ensures that consumers are not caught in the competitive tug-of-war
between doctors and third party sellers for the sale of contact lenses."
CooperVision also spoke out against
S. 2480 in July and contacted the National Association of State Attorneys General
regarding the shortcomings of the proposed amendment. "We believe that S. 2480 will
have detrimental effects on patient health, create barriers of entry for new innovative
products and hurt the quality of service if manufacturers lose control over the
distribution of their products," said Jeff McClean, president of CooperVision Americas.
• In September, Representative
Ed Whitfield (R - KY) introduced HR 6117, the Contact Lens Consumer Health Protection
Act, a bill to protect consumers who buy contact lenses from third-party vendors.
The bill would amend the Fairness to Contact Lens Consumers Act (FCLCA) and establish
a toll-free Patient Safety Hotline for eyecare practitioners who have patient health
concerns related to a prescription verification request. A call to the hotlines
would suspend the transaction until the vendor addresses the specific health concern.
It would further allow providers to specify their preference for fax, e-mail or
telephone for prescription verification purposes. The vendor would then have to
attempt at least two of the three communication choices.
The introduction of this legislation
followed a Sept. 15 hearing on H.R. 5762, the Contact Lens Consumer Protection Act,
before the Energy and Commerce Subcommittee on Commerce, Trade and Consumer Protection.
Wiley Curtis, OD, testified on behalf of the AOA and said the group has received
hundreds of FCLCA violation complaints about sellers.
Testifying on behalf of the AAO, Oliver
Schein, MD, said, "Passive verification is a flaw in the FCLCA that the [AAO] believes
lowers the bar for patient safety and opens the door for prescription verification
failures that can ultimately result in patient harm." Gregory Fryling, COO of CooperVision,
also testified against H.R. 5762.
Jonathan Coon, Chairman and CEO of
1-800 Contacts, and Wayne Klein, Assistant Attorney General for the state of Utah,
testified in favor of the bill.
"To date there has been no meaningful evidence
that the [FCLCA] is not working or that passive verification is not the right system
to manage the conflict of interest of a doctor selling what they prescribe," said
Mr. Coon. "H.R. 5762 would protect consumers and promote competition and would remove
the ability of any manufacturer to entice doctors with offers of increased profits
by restricting consumer choice."
Global Keratoconus Congress 2007
The first-ever Global Keratoconus Congress will
take place from Jan. 26-28, 2007 in Las Vegas. The GKC is an assembly of experts
in the field of patient care, teaching and research. They will share the latest
information on this chronic sight-threatening condition that affects one in 2,000
people. Attendees will learn about the latest approaches to contact lens fitting,
surgical techniques, clinical research and appropriate third-party reimbursement
for medically necessary contact lens care. Manufacturers and laboratories that support
the care of these patients will assist in demonstrating the usefulness of their
latest products and treatments. Please visit www.GKC2007.com for more information.
Mourning Their Loss
Former CEO of Boucher Communications, Inc. (BCI)
Bob Boucher, passed away in 2006. BCI published several leading eyecare-related
publications, including Ophthalmology Management, Optometric Management,
Eyecare Business and Contact Lens Spectrum, as well as the CLToday
and Optometric Management Tip of The Week e-mail newsletters. Wolters Kluwer
purchased BCI in September 2005.
Contact lens innovators, developers and manufacturers
David Garfield Ewell, OD, founder of Kontur Kontact Lens Company; Charles Patrick
Creighton, OD, MS (Alden Optical); and Melvin Sanford (Conforma Contact Lenses)
passed away in 2006.
We will miss them.
Looking Ahead
Some industry experts are concerned that sensationalized
contact lens infection discussions and lens solution recalls in 2006 bode unfavorably
for a healthy contact lens industry in 2007. We disagree strongly. Certainly we
need to do everything we can to prescribe and dispense the healthiest lenses with
the most compatible care systems. We also need to work as hard as we possibly can
at treatment plan adherence and compliance to promote healthy lens wear and prevent
complications. Critics have tried for decades to challenge contact lenses. But the
growth of contact lens use in the United States and elsewhere has continued and
will continue. The technology and our knowledge is better than ever and both will
keep improving. Stay tuned and we'll be happy to tell you all about it.
Fusarium Keratitis and ReNu with MoistureLoc
Timeline
FEBRUARY
— Reports of an outbreak
of Fusarium keratitis in contact lens wearers using B&L's ReNu multipurpose
solution products were first addressed. The company worked with the Singapore Ministry
of Health and initially found no definitive link between any particular product
and the outbreak there or in Hong Kong. Independent testing of the various ReNu
products confirmed the products were sterile.
MARCH —
Researchers at the Centers for Disease Control and Prevention and B&L collected
and tested a number of samples, all of which were highly effective in biocidal efficacy
against Fusarium species. The company worked with the CDC to investigate
the incidence of these infections around the world. B&L later voluntarily agreed
to suspend sales of ReNu brand contact lens solutions in Singapore.
MAY 11 —
B&L China removed locally made ReNu with MoistureLoc products from the market.
The action had the support of the Chinese regulatory agency. Early in the investigation
B&L stated, "It would be expected that the distribution of lens care products
associated with these cases would be roughly proportional to the products' relative
market share." The company admitted, however, that the 57-percent share of cases
preliminarily reported for the MoistureLoc formulation was disproportionately higher
than its U.S. market share of less than 10 percent. B&L says this disproportionate
representation is the reason the company voluntarily withdrew MoistureLoc while
the investigation continued. In one report, 19 cases reported using ReNu MultiPlus,
nine reported using an unspecified ReNu brand, three used Advanced Medical Optics'
(AMO) solutions and four used solutions from Alcon. Some cases reported using more
than one type of solution.
MAY 21 —
B&L initiated a permanent, global recall of ReNu with MoistureLoc after an internal
investigation. B&L conducted a "topping off" test and found that over time,
numerous solutions including MoistureLoc worked poorly against Fusarium strains
isolated from infections. Brian Levy, OD, MSc, Chief Medical Officer for B&L
says if the solution is concentrated by simulating evaporation (take water out of
the formula), MoistureLoc tends to lose efficacy against Fusarium. If a patient
discards the used solution, but leaves a film of MoistureLoc on the bottom of the
lens case, the concentrated polymer film (dehydrated and condensed wetting and cushioning
agents) could protect so that the Fusarium fungus could not be attacked by
the solution's preservative, alexidine. The company also found this film could form
on the bottle tip, which could lead to continuous inoculation of the cornea with
Fusarium.
Dr. Levy says that MultiPlus maintains full biocidal efficacy
when put through the same tests as MoistureLoc.
B&L worked closely with the CDC and the Wilmer Eye Institute
of Johns Hopkins University to implement a multi-center surveillance program to
establish the actual incidence. The company also changed its recommendation for
replacing lens cases from once every three months to once per month, and stressed
the importance of proper lens cleaning and care. B&L launched a consumer promotion
program to encourage use of its long-standing mainstay product, ReNu MultiPlus,
and offered free lens cases to be replaced every month.
JUNE 30 —
Researchers identified 164 confirmed case patients in 33 states and one U.S. territory.
One-hundred-fifty-four (94 percent) wore soft contact lenses. The median patient
age was 41. Corneal transplantation was required or planned in 55 patients (34 percent).
Case patients were significantly more likely than controls (69 percent vs. 15 percent)
to report using ReNu with MoistureLoc.
The researchers did not recover Fusarium from the factory,
warehouse, solution filtrate or unopened solution bottles; production of implicated
lots was not clustered in time. They concluded that the outbreak of Fusarium
keratitis was associated with use of ReNu with MoistureLoc contact lens solution
and caution that contact lens wearers should not use it.
AUGUST –
Research results published in the Journal of the American Medical Association.
Dr. Barr is a professor and associate dean
for clinical services and professional program at The Ohio State University College
of Optometry.
Contact Lens Spectrum, Issue: January 2007