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Sunday, March 6, 2011  
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Care Solution Corner
Susan J. Gromacki, OD, MS, FAAO

At its Ophthalmic Devices Advisory Panel (2008) and Microbiological Testing of Contact Lens Care Products Workshop (2009), the United States Food and Drug Administration (FDA) sought advice on how to improve its regulatory testing of multipurpose contact lens care products.

The contact lens solution-related keratitis outbreaks demonstrated that Acanthamoeba - currently not included as a test organism - should be represented in the FDA's revised guidance. The FDA is now studying the optimal ways to grow, harvest, and form cysts so that Acanthamoeba may be added as a test organism.

These outbreaks also highlighted the need for more "real world" test conditions. The present International Organization for Standardization (ISO) Stand Alone test is useful, but does not include a contact lens or case in its procedure. A new methodology is currently being developed by the Contact Lens Institute, with input from the FDA, and is being evaluated with a ring test of five different laboratories. This potential new methodology will also utilize representative silicone hydrogel lenses, which are not required for the current testing methods.

For more on this topic, Click Here.

Ocular Surface Update
Kelly K. Nichols, OD, MPH, PhD, FAAO

There is a lot we do not understand about dry eye. In part, this is due to the difficult nature of studying the cornea, tears (lipids, proteins), nerves, and related glands (lacrimal, accessory, and meibomian glands). The complex interaction between all of these components, leading to ocular surface homeostasis and disruption in disease, is largely unknown. Some of the advances in understanding of the proteome in other conditions are made much easier by having enough tissue or sample from which to do research analyses, e.g. blood. When you are talking about small samples, such as cells collected from the ocular surface, or tears collected in micro-volumes, the research analysis becomes extremely challenging.

One area where headway is being made is in the understanding of ocular surface signaling via toll-like receptors (TLRs). Before you stop reading, consider the following. The key to new therapeutics for ocular surface diseases will come through the understanding of signaling pathways, and the toll-like receptor pathways are currently candidates for inflammatory ocular surface conditions like dry eye, microbial keratitis, and conjunctivitis. In their elegant review of toll-like receptors, Redfern and McDermott indicate the possibility of TLR involvement in dry eye, with a possible link to hyperosmolarity in-vitro. Further in-patient translational research is needed in this hot-topic area.

Redfern RL, McDermott AM. Toll-like receptors in ocular surface disease. Experimental Eye Research 2010;90: 679-68.


Novartis Appoints Kelman to Head OTC division

Novartis announced that Naomi Kelman is appointed Head of the Novartis OTC Division and will become a permanent attendee to the Executive Committee of Novartis (ECN), reporting to Joseph Jimenez, CEO of Novartis.

Kelman joins Novartis from Johnson & Johnson where she has held several leadership roles within both the Consumer and Medical Device and Diagnostic Sectors.

The Novartis OTC and Animal Health businesses will become separate Novartis divisions, in addition to the Pharmaceuticals, Sandoz (generics), Vaccines & Diagnostics Divisions. As previously announced, following the completion of the merger between Novartis and Alcon, CIBA Vision and Novartis ophthalmic medicines will be merged into the new Alcon eye care Division of Novartis. Until the close of the Alcon transaction, George Gunn will continue to manage the CIBA Vision business. Gunn will remain a member of the ECN in his new role as Head of Animal Health and has additionally become responsible for Corporate Social Responsibility for Novartis (CSR), elevating CSR to the Executive Committee level.


Online GP Sphere and Toric Lens Calculator Now Available

The GP Lens Institute (GPLI) has added a new, dynamic online tool to aid eyecare practitioners in empirical design of GP for astigmatism, the GP Sphere and Toric Lens Calculator, to their website, www.gpli.info. The Calculator was developed by Drs. Tom Quinn and Ed Bennett and brought online with the assistance of Dr. Todd Zarwell of EyeDock.com.

For patients manifesting ¾ to 2D of corneal cylinder, the Calculator presents an empirical method of determining GP spherical lens power, base curve radius, overall diameter and peripheral curve values. For patients with greater than 2.00D of corneal astigmatism, a GP toric lens will be recommended and the toric lens powers, base curve radii, and overall diameter will be provided via the assistance of dynamic "on-eye" optical crosses.

The eyecare practitioner simply inputs the patient's keratometry (or simulated "K") values, and refraction and the recommended lens design parameters will be provided. As with any empirical calculator, there is no guarantee of first fit success; however, the resulting design should be a very good starting point toward successful GP lens wear.

ABB Concise Unveils New Website

The ABB Concise business-to-business website, www.abbconcise.com, received a makeover to add more information about the products and services ABB Concise offers its customers.

In addition to the features customers are accustomed to using, the following enhancements are available: live chats with customer service; the replenishment ordering system; previously recorded Practice Partnership GP Webinars; a news section; new Parameter Guide and more.

The new, enhanced Parameter Guide offers customers the ability to search actual RX parameters to effectively find the right product for their patients' needs. The online functionality for orders sent directly to a patient's home or office was enhanced to allow an efficient use of the secure patient directory. The patient directory managed on abbconcise.com is also the same patient registration system for yourlens.com. That means that the patient data is stored in one place which ABB Concise customers can utilize for both abbconcise.com and yourlens.com powered web store.

AOA Opens Registration for 2011 Optometry's Meeting

The American Optometric Association (AOA) announced that both registration and housing reservations are open for this year's meeting which will be held in Salt Lake City, Utah, June 15 - 19, 2011.

AOA and AOSA members who register for Optometry's Meeting and use the official housing bureau during the early-bird registration period will be entered to win a complimentary base registration and up to four nights' hotel stay for the meeting. The winner will be drawn on April 2 and will be contacted by the AOA. For more information on this year's meeting and to register visit www.optometrysmeeting.org.

An electronic Preliminary Program (e-brochure) is also available on-line for your convenience.

Alcon and Novartis Schedule Shareholder Meetings to Vote on Merger

Novartis announced that it has scheduled an Extraordinary General Meeting (EGM) on April 8, 2011, where Novartis shareholders will vote on the proposed merger with Alcon, as well as the proposed share capital increase. Both items have been recommended by the Novartis Board of Directors for approval.

This follows the US Securities and Exchange Commission having declared effective on February 25 the company's registration statement on Form F-4 relating to the merger. Effectiveness of the Form F-4 marks a milestone for the closing of the merger, with a last condition receipt of two-thirds approval by the shareholders of each of Novartis and Alcon voting at their respective meetings.

Alcon, Inc. also announced that it will hold its Annual General Meeting of shareholders on April 7, 2011. In addition to other matters, the company's shareholders will vote on the proposal to merge the company into Novartis AG.

This month at www.siliconehydrogels.org: Ethnic differences in ocular physiology, tear mixing and contact lens-related adverse events, risk factors for inflammatory and mechanical events, and our synopsis of the 2010 meeting of the American Academy of Optometry.

Editor's Commentary
Jason J. Nichols, OD, MPH, PhD, FAAO

As you will note, our featured abstract this week is on keratoconus. While many of us work with patients with keratoconus frequently, there are many eyecare practitioners who do not often see these patients. If you review the literature on the epidemiology of keratoconus, the prevalence of the disease has been estimated to be around 50/100,000 while the incidence is estimated to be 1-2/100,000/year (Kennedy et al, 1982). I find it interesting that many people feel that these values actually underestimate the true frequency of this disease. We certainly have many contact lens options to offer these patients today, which in most instances, will optimize their visual function and quality of life.

Kennedy, et al. A 48-year clinical and epidemiological study of keratoconus. Am J Ophthalmol 1986; 101:267-73.

CLToday Quick Poll

Last week's question:
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The Lifetime Economic Burden of Keratoconus: A Decision Analysis Using a Markov Model

The authors wanted to estimate the expected incremental lifetime cost of treatment of keratoconus compared to the expected cost of the treatment of myopia.

They worked up a cost estimate from the patient's perspective using a Markov decision model. They modeled a hypothetical cohort of people with clinically significant incident keratoconus as defined by the Collaborative Longitudinal Evaluation of Keratoconus (CLEK) Study. Included were costs of clinic visits, fitting fees, contact lenses, surgical procedures, and complications. Survival curves of corneal transplants and associated complications were modeled using data from the 2007 Australian Graft Registry. Medical treatment regimens after surgery were defined by expert opinion.

The expected value of the lifetime cost of the treatment of keratoconus over myopia was $25,168 with a standard deviation of $16,247 and a median of $17,596. The factors that most influenced the lifetime cost were the probability of initial corneal transplant and a subsequent regraft. The cost of routine care had relatively little influence on the lifetime cost of care.

The expected lifetime cost of treatment of keratoconus represents a significant cost to patients and payors. While the cost of routine care for keratoconus is not trivial, the primary factor influencing changes in the cost of care for keratoconus is the probability of corneal transplant. Combined with the significantly impaired vision-related quality of life and the relatively young onset of disease, the economic burden of the treatment of keratoconus represents a significant public health concern.

Rebenitsch RL, Kymes SM, Walline JJ, Gordon MO. The Lifetime Economic Burden of Keratoconus: A Decision Analysis Using a Markov Model. Am J Ophthalmol 2011.

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To report possible grievances related to the Fairness to Contact Lens Consumers Act or associated Contact Lens Rule visit: https://www.ftccomplaintassistant.gov/.

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