CONTACT LENSES TODAY
July 29, 2007
Contact Lenses Today® is edited by Dr. Joseph T. Barr and the staff of Contact Lens Spectrum. This week CLToday® reaches more than 12,000 readers in 74 countries.
AMO to Reenter Solution Market, Issues Statement on B&L Letter
Advanced Medical Optics (AMO) announced it plans to begin shipping a multipurpose solution in the U.S. in the first half of August and expects the product will be widely available
in the U.S. by early September, with plans to ship to other global region in a phased-in approach throughout the fall. The company had previously estimated the product would not be available until late
September.
AMO says its new product will focus on comfort and disinfection efficacy, incorporating the importance of proper handling and care, per the guidelines set forth by the American Academy of
Optometry (AAO), American Optometric Association (AOA), American Academy of Ophthalmology (AAO) and the American Society of Cataract and Refractive Surgery (ASCRS). The company expects to provide more
information during its second quarter earnings conference call on August 2.
AMO also issued a statement in response to the letter it received from the Special Committee of the Board of Directors
and the Board of Directors of Bausch & Lomb (B&L): “We continue to believe in the strategic and financial rationale for this combination and are confident in our ability to consummate the transaction,” the
statement says. “AMO’s proposed transaction would … allow both companies’ shareholders to share in the upside potential of a combination that we believe will deliver significant cost-saving opportunities. We
are evaluating B&L’s letter and will respond to it in due course.”
Menicon Acquires Flat-Pack Technology
Menicon Co. is now the sole owner of ClearLab International’s flat-pack technology, through an acquisition agreement with 1-800-CONTACTS and ClearLab. This allows Menicon to
commercialize the technology as flat-pack daily disposable contact lenses and to license the technology to other manufacturers. The company will manufacture the flat-pack daily disposable lenses in Singapore
for export to global markets.
BCLA Calls for Submissions
The British Contact Lens Association (BCLA) is inviting proposals for clinical presentations at the 32nd Clinical Conference and Exhibition in Birmingham from May 29 to June 1,
2008. Presentations can be on any topic relevant to the contact lens and anterior eye, must have a practical approach and allow delegates the opportunity to learn new clinical skills. Presenters are entitled
to complimentary conference registration and will gain points towards the new BCLA Fellowship scheme. Applications must be submitted online by September 21, state the purpose of the presentation, clinical
content, format and four learning objectives.
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Important Safety
Information
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Global Keratoconus Congress 2008
Contact Lens Spectrum and the LWW Health Care Conference Group will host the second Global Keratoconus Congress (GKC), January 25-27, 2008, at Bally’s Hotel and Casino
in Las Vegas, NV. As with the 2007 meeting, the 2008 congress will include information for vision care professionals in all disciplines, with both surgical and non-surgical treatment options. GKC 2008 will
also feature 15 new speakers providing hands-on workshops, strategies for irregular astigmatism and expert insights into fitting after surgery and corneal trauma. More than 500 participants attended the 2007
meeting, which was accredited for continuing education under COPE, NCLE and JCAHPO and offered 17.5 credit hours. Those interested in attending the 2008 Global Keratoconus Congress can visit www.GKCongress.com
for more information or to register for this unique meeting. Companies interested in exhibiting should contact Heather Seasholtz at 215-643-8073.
Additionally, the Educational Program Committee of the
Global Keratoconus Congress invites the submission of abstracts for the Free Papers and Scientific Posters Competition to be held January 25-27, 2008 in Las Vegas. Papers and Posters related to keratoconus,
corneal topography, post penetrating keratoplasty or related irregular corneal surface, gas permeable lens and lens care topics are welcome. Please visit
http://www.GKCongress.com for
information.
--ADVERTISING
Crystal Reflections
The FDA issues a warning letter to contact lens maker Crystal Reflections International for its change control procedure being unsigned and undated. The FDA said changes to documents
were made via post-it notes. The letter also said the firm failed to perform bioburden testing, even though the company’s quality assurance procedure required it. The FDA further said that the company failed to
establish and maintain procedures for receiving, reviewing or evaluating complaints. The company had no records of complaints, but the FDA said there were records of product deficiencies in other locations that
would be classified as complaints. Finally, the agency said that Crystal Reflections has not performed an audit since the company began manufacturing in 2000.
Unilens Names New CEO
Unilens Vision announced the appointment of Michael Pecora as President and Chief Executive Officer (CEO), succeeding Alfred Vitale who will retire effective July 31. Mr. Pecora has
served as our Chief Financial Officer (CFO) of Unilens Corp, USA, the company’s operating subsidiary since 1994. Mr. Vitale will remain a Director and Chairman of the Board as well as a consultant and special
advisor to Mr. Pecora and the Board of Directors through December 31, 2007. Succeeding Mr. Pecora as Vice President and CFO is Leonard Barker, who has served as Manager of Accounting for the company since
2005.
Eyemaginations Opens European Headquarters
Eyemaginations announced its worldwide expansion with the opening of its international headquarters in Erlangen, Germany. “This announcement represents the continuation of a
very strong growth trend for Eyemaginations,” said president and CEO, Jeffrey Peres.
Robert Habel will head the new headquarters as Vice President of International Sales and General Manager of
Eyemaginations Europe GmbH. Mr. Habel comes to the company from WaveLight AG.
Abstract:
Complications with Continuous Wear of Lotrafilcon A CLs
A study published in this month’s Eye & Contact Lens journal reports on the ocular complications that occurred during a three-year clinical trial of subjects wearing
lotrafilcon A silicone hydrogel contact lenses for up to 30 nights of continuous wear. A total of 19 sites enrolled 317 subjects who were dispensed lotrafilcon A lenses with three years of
follow-up.
At the one-month visit, practitioners recommended continuous wear for up to 30 nights for 87% of participants. There were 37 lens-related adverse events, including 15 eyes (3%) in
year-one, seven (1%) in year-two and five in year-three. Lens-related inflammatory events involved 12 eyes (2%) in year-one and five eyes each in year-two and -three. One-third of the inflammatory
events occurred in the first three months. Mechanical events included two superior epithelial arcuate lesions and one case of bilateral contact lens papillary conjunctivitis in year-one and -two. No
subjects experienced microbial keratitis during the three-year trial. Two subjects with events discontinued participation in the trial.
The authors conclude that the rate of contact lens adverse
events occurring with lotrafilcon A is low in this cohort, with the highest likelihood of occurrence in the first three months of the study. They note that while it’s important for clinicians to
understand the likelihood of adverse inflammatory and mechanical events and their possible recurrence, the rate of those events may be lower in practice than previously reported.
Donshik P,
Long B, Dillehay SM, Bergenske P, Barr J, Secor G, Yoakun J, Chalmers RL. Inflammatory and Mechanical Complications Associated with 3 Years of up to 30 Nights of Continuous Wear of Lotrafilcon A Silicone
Hydrogel Lenses. Eye Contact Lens. 2007 Jul;33(4):191-5.
Editor's Commentary:
Improving GP Comfort
Dr. Mellinger raised a good point in last week’s Fitting Tip (see CLToday, July 22) that a low-powered soft lens often will improve contact lens comfort in our keratoconus
patients. I'd also add that we have had good success using moderate plus-powered lenses, from a 2.00D to a 5.00D, under GP lenses that are decentered inferiorly over moderate to advanced inferiorly decentered
cones. In some cases, GP lens centration is dramatically improved. As the GP is raised off the lower lid, patient reports of contact lens induced discomfort are also dramatically improved. We also use a
silicone hydrogel lens in most cases and will trial different plus powers, increasing the plus until we achieve the desired amount of lens centration. Even when vision is not improved, I've found these
patients are willing to tolerate the extra handling and care of two lenses.
Recently, we fit a keratoconus patient with a 5.00D silicone hydrogel under a GP lens with a 5.1mm base curve. Previously,
lens decentration caused the GP to pop out several times a day. He returned for a three-month follow-up stating that his GP lens had not popped out of his eye at all. Both he and his wife were quite
pleased.
Carla Mack, O.D., F.A.A.O.
Fitting Tip:
Making Multifocals Work
I've found that my students become frustrated with multifocal contact lenses because they spend countless visits trying to "tweak" lens powers. My rule-of-thumb is to make
only two changes to the power of a given lens design. After that, if the patient is still not successful, it’s time to switch lens designs (try a concentric ring, instead of an aspheric, etc). And don't
forget about aspheric and translating GP lenses!
Kathryn Richdale, O.D., M.S., F.A.A.O.,
Columbus, Ohio.
This month at http://www.siliconehydrogels.org enter the topical discussion into the classification of silicone hydrogel lenses
into specific categories. Follow the work of Dr Phil Morgan et al who have independently examined the oxygen permeability of current silicone hydrogel lenses using a new and repeatable technique, and read into
the use of custom designed silicone hydrogel lenses.
Report adverse contact lens reactions here: http://www.accessdata.fda.gov/scripts/medwatch/ or call (800)
FDA-1088.
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