Workshop to Examine Lens Care Product Testing
A public workshop titled "Microbiological Testing for Contact Lens Care Products" will take place Jan. 22-23, 2009, from 8:00 am to 5:00 pm.
The purpose of the workshop is to discuss test methods for evaluating the anti-microbial activity of contact lens care products with the goal to reach consensus on critical test method parameters for evaluating the activity of contact lens care products against Acanthamoeba. These parameters include organism species and strain, trophozoite culture and cyst production, microbial challenge level and assay method for survivors.
The workshop also will include presentations and discussions on critical elements for new or modified disinfection efficacy test methods that simulate "real world" consumer use conditions. These elements include contact lens and contact lens case uptake of preservative and other solution ingredients, solution evaporation, minimal consumer compliance, biofilm formation and clinical isolates as challenge organisms.
This workshop is cosponsored by the American Academy of Ophthalmology, the American Academy of Optometry, the American Optometric Association and the Contact Lens Association of Ophthalmologists in conjunction with the U.S. Food and Drug Administration (FDA). It will be held at the FDA's White Oak Conference Center in Silver Spring, Maryland. Registration for the workshop must be completed online at www.jcahpo.org/clmw by Jan. 8, 2009. There will be no onsite registration.
Biofinity Gets Extended Wear Approval
The U.S. Food and Drug Administration (FDA) has approved Biofinity silicone hydrogel lenses for extended wear in the United States, allowing overnight wear for up to six nights and seven days. This approval applies to all available Biofinity monthly replacement contact lenses.
With this approval, practitioners can use lenses from their existing Biofinity fitting sets to fit patients with Biofinity contact lenses for extended wear.
"Aquaform technology creates a naturally wettable lens material without the need for wetting agents or surface treatments," said James Gardner, director of marketing, CooperVision. "With a high Dk/t of 160 and the FDA clearance for extended wear, practitioners can now offer a very high oxygen silicone hydrogel lens which is almost 50 percent softer than the highest Dk silicone hydrogel lens currently available."
CLMA Holds 47th Annual Meeting
The 47th Annual Meeting and Exhibition of the Contact Lens Manufacturers Association (CLMA) was held Nov. 13 to 16 at the Renaissance Ross Bridge Resort & Spa outside of Birmingham, Ala. The educational program focused on high-index GP materials, large diameter GP lens applications, myopia control and marketing and selling lenses to practitioners.
Dr. William "Joe" Benjamin presented the keynote address on "optical curiosities of contact lenses" Other presenters included Dr. Eef van der Worp who discussed scleral lens fitting from an international perspective, Tim Koch who discussed corneal imaging in the digital age and Patrick Caroline, FAAO, who presented a myopia control update.
At the annual awards banquet, the following individuals were honored: GP Lens Practitioner of the Year: Robert L. Davis, OD, FAAO; Trailblazers Award: Thomas E. Anastor; Industry Enhancement Award: David B. Bland; Creative Design and Process Award: Robert O. Breece, OD; Honorary Recognition Award: George K. Meszaros. Elections to the CLMA Board of Directors were as follows: President: Chris Pantle; Immediate Past President: Janice Schramm; Vice President: Al Vaske; Secretary/Treasurer: Ken Leonhard; Board Members Andy Jackson, Dan Bell, David Bland, Jan Svochak, John Walfoort, Keith Parker and Tim Koch.
The next CLMA annual meeting will take place the first weekend in November in San Antonio, Texas.
|Unilens Acquires Aero|
|■ Unilens Vision Inc. has acquired the specialty GP contact lens manufacturer Aero Contact Lens, Inc. Under the terms of the agreement, Unilens acquired certain assets of Aero Contact Lens, Inc., including regulatory approvals, customer lists, trade names and various other resources. The GP Aero Contact Lens brands acquired through the asset purchase include the V/X Multifocal, the Aspirations Multifocal and the R-2000 Keratoconus Lens. The lenses will be manufactured and marketed by Unilens under their pre-existing product brand names from the Unilens Corp.|
Customer service and consultation will continue from the Aero Michigan office and current Aero pricing and policy programs will stay in effect to ensure a smooth transition.
"This acquisition, along with the recent launch of the C-Vue Advanced Custom Toric and the C-Vue 1 Day daily disposable, illustrate Unilens' commitment to support independent eyecare professionals throughout the U.S." said Michael Pecora, chief executive officer of Unilens Vision Inc.
Rose K Questions Answered
Since Menicon Co., Ltd., purchased Rose K International Limited, North American practitioners have had a number of questions, reported Lee Buffalo, director of Sales and Marketing, Blanchard Contact Lens, Inc.
The top question has been whether the change in ownership will affect product availability, professional support or business policies.
The response is an unequivocal "no," said Jonathan Jacobson, Menicon's general manager of global business strategy and operations. "The existing arrangements related to manufacturing and distribution of Rose K lenses in North America have not been affected, and fitters should continue to obtain Rose K lenses from Blanchard Contact Lens and its network of authorized Rose K distributors," he said.
Practitioners also have asked whether the change of ownership means they will need to obtain lenses in Menicon Z material. In response, Jacobson said, "Rose K lenses continue to be available in Boston materials from Blanchard Contact Lens and Rose K distributors throughout North America. There are no plans to convert Rose K lenses from Boston materials to Menicon Z." However, practitioners who would like to order a Rose K lens specifically in Menicon Z material should contact Blanchard or their Rose K distributor for availability.
Dr. Paul Rose will continue as a consultant to Menicon.
"We see this as a positive change for the keratoconus and irregular cornea GP contact lens fitter, as it will bring Menicon's additional resources to helping address the needs of these patients across the world," Mr. Buffalo said.
|Independent Soft Lens Prices Increase in 2008|
|Independent eyecare professionals increased their retail prices of 20 leading soft contact lens brands by a weighted average of 1.3 percent in 2008, according to data reported by the ABB Concise Soft Lens Retail Price Monitor.|
Data indicated that, in 2008, independent eyecare professionals raised retail prices for 18 of 20 brands analyzed and decreased prices for two. The average prices increased 1 percent for brands in each major lens segment.
Estimates are derived from quarterly audits performed by ABB Concise of retail pricing by independent eyecare professionals. Reported average prices are averaged from four quarterly audits in 2007 and 2008. The pricing of more than 450 practices is used to calculate the averages for each year. The composite average included brands audited in each of the eight quarters over the past two years. These brands account for approximately 76 percent of wholesale sales of frequent replacement contact lenses.
As independent eyecare professionals increased prices of 90 percent of audited brands analyzed in 2008, the mail-order/Internet company 1-800 Contacts increased prices on only two of these brands. The pricing comparison of 1-800 Contacts is based on its pricing in the fourth quarter of each year.
CLS Editorial Changes for 2009
Each year when we plan our editorial calendar for the following year, we also assess our departments to determine whether our monthly topics are meeting the informational needs of our readers.
This year we are introducing a new bimonthly department titled Research Review. This column will present an overview of the latest research in the contact lens and eyecare fields. Longtime CLS contributing editor Loretta Szczotka-Flynn, OD, MS, FAAO, an associate professor at the Case Western Reserve University Dept. of Ophthalmology & Visual Sciences and director of the Contact Lens Service at University Hospitals Case Medical Center, has written the first column of this department, which appears on p. 15 of this issue. Alternating with Dr. Szczotka-Flynn will be returning contributing editor Lyndon Jones, PhD, FCOptom, FAAO, associate director of the Centre for Contact Lens Research and a professor at the School of Optometry at the University of Waterloo, Ontario, Canada.
We also are introducing a new Point/Counterpoint department that alternates with the Research Review department and will debut in our February issue. In this department, two experts will discuss opposing sides of a contact lens or eyecare-related topic.
Many of our contributing editors from 2008 are remaining on staff for 2009, but we do have some new faces in our lineup this year.
Kathy Dumbleton, MSc, MCOptom, FAAO, a senior clinical scientist of the Centre for Contact Lens Research, School of Optometry, University of Waterloo, Canada, will co-write columns with Dr. Lyndon Jones for the Contact Lens Materials department.
Katherine M. Mastrota, MS, OD, FAAO, center director of the New York Office of Omni Eye Services, will contribute columns to our Dry Eye Dx and Tx department.
Gregory W. DeNaeyer, OD, clinical director for Arena Eye Surgeons in Columbus, Ohio, will contribute to our Online Photo Diagnosis department. This department features an image of a clinical eyecare condition and appears on the page following our Table of Contents page each month. You can find information on the diagnosis and treatment options of the current month's online photo on our home page at www.clspectrum.com, while information for past online photos is available with the archived content for each issue on the Web site.
We also extend our heartfelt thanks to a few great contributing editors not returning for 2009, including Brad Giedd, OD, MS, FAAO, Julie A. Schornack, OD, MEd, and William "Joe" Benjamin, OD, MS, PhD. We appreciate their diligent work and dedication over the last year and wish them all the best.
|Paragon CRT Gets Wired Mention|
|Wired magazine recently published an online periodical that featured Paragon CRT as one of "10 Best NASA Spinoffs." Wired is a monthly magazine and online periodical that reports on how technology affects culture, the economy and politics.|
|■ Earlier this year, Alcon redesigned its Opti-Free Replenish MPDS starter kits to make them more environmentally friendly. Now, working with the optometric community and the Arbor Day Foundation, Alcon is planting thousands of healthy young trees in National Forests across the United States. Alcon asked optometrists across the nation if they would like to participate in this initiative, and thousands responded to help Alcon achieve its goal of planting 10,000 new trees.|
■ Bausch & Lomb's Board of Directors has elected Susan A. Roberts as a corporate vice president. She has been the company's chief compliance officer since 2006 and heads the global pharmacovigilance and safety surveillance groups. Ms. Roberts joined B&L in 1995 and has held positions of increasing responsibility in the B&L Law department.
■ The Institute for Eye Research is conducting a series of research projects aimed at the development of the "perfect contact lens" — a lens that will not only provide excellent vision correction and fit the eye perfectly, but also eliminate the possibility of any inflammation caused by contact lens wear especially as a result of bacterial buildup. The research projects have investigated whether contact lens wear carries increased risk of infection if worn by children and new ways to minimize microbial adhesion to lenses as well as investigations into the tear film. Findings are due to publish in several clinical and basic science journals.
■ Cynacon/OcuSoft has announced findings from a recent study indicating that its OcuSoft Lid Scrub Plus, a "leave-on" formulation, effectively eradicated Demodex mites. According to the company, no other eyelid cleanser used according to maufacturer's instructions kills Demodex. Recent reports suggest that Demodex mites contribute to meibomian gland dysfunction, meibomitis, blepharitis and other eyelid irritations. Also, a variety of corneal pathologic features, together with conjunctival inflammation commonly noted in rosacea, can be found in patients with Demodex infestation of the eyelids.
■ Alcon has announced that the European Medicines Agency (EMEA) has approved Alcon's fixed combination eye drop Azarga (brinzolamide 10mg/ml + timolol 5mg/ml) ophthalmic suspension for treating elevated intraocular pressure associated with open-angle glaucoma or ocular hypertension in adult patients for whom monotherapy provides insufficient IOP reduction. The company says two clinical studies have shown Azarga ophthalmic suspension to be more comfortable and better tolerated by patients than Cosopt (Merck & Co, Inc.). Clinical trials supporting the approval also showed that the active ingredients in Azarga are more effective when delivered in combination than either of them individually.
■ InSite Vision Inc. has announced preliminary results from the company's Phase 3a clinical trial of ISV-502 (AzaSite Plus), a topical combination antibiotic/corticosteroid product for treating blepharoconjunctivitis. ISV-502 improved clinical outcomes as compared to treatment with a corticosteroid alone or antibiotic alone in the reduction of inflammatory signs and symptoms and bacterial eradication, respectively. In addition, ISV-502 was well tolerated. However, an initial evaluation of the data indicates that the trial did not achieve its primary endpoint as defined by the protocol.
■ Motivation Mechanics, an independent opinion polling and marketing research services company, has announced a new online division, Vision Research Center, Inc. (VRC). VRC was developed as a specialty research site focused on gathering information on physician and patient perceptions of vision-related diseases, including their diagnosis and treatment. The site, www.visionre-searchcenter.com, was conceived to provide a platform for experts to share opinions about new technologies and therapies in an online community setting and to help accelerate the diffusion of new ideas into patient care.
■ Dr. Gary Heiting, a veteran of clinical optometric practice, the eyewear industry and online publishing, has been named Associate Editor of All About Vision. A contributing editor of All About Vision since April 2007, he will now be responsible for the content sections on a variety of eyecare subjects.