CONTACT LENSES TODAY

October 10, 2004

Contact Lenses Today® is edited by Dr. Joseph T. Barr and the staff of Contact Lens Spectrum. This week CLToday® reaches more than 10,000 readers in 74 countries.

B&L Challenges OSI
Bausch & Lomb filed a lawsuit in U.S. District Court for the Western District of New York in Rochester against Ocular Sciences, Inc. for infringement of a B&L patent (U.S. Patent No. 6,113,236) that relates to toric contact lenses used to correct astigmatism. B&L asked the court for injunctive relief to require OSI to discontinue manufacturing and sales in the United States of its infringing toric lens until the B&L patent expires in 2018. B&L also asked for unspecified monetary damages for infringing its patented technology. Says OSI President and CEO Stephen J. Fanning, " . . . we have been in discussion with Bausch & Lomb on this matter since January 2004, have investigated the matter in detail and believe that our patented Biomedics toric soft contact lens and the private label equivalent do not infringe the Bausch & Lomb patent."

FDA Approves O₂OPTIX for Six Nights of EW
CIBA Vision has received both FDA and CE mark approval for up to six nights of extended wear (EW) with its O₂OPTIX contact lens. The lens is also approved for six nights of EW in Canada. "Obtaining FDA and CE mark approval for six night extended wear is a major milestone in bringing this breakthrough contact lens to market," says Andrea Saia, president of CIBA Vision's global lens business. For more information on the new lens, visit http://www.o2optix.com

NIH Rejects Petition to Break Glaucoma Patent
The National Institutes of Health (NIH) has stated that it will not exercise "march-in" rights on Xalatan (latanoprost ophthalmic solution 0.005%) under the federal Bayh-Dole Act, which authorizes the government to license federally funded interventions to other firms in certain circumstances. A consumer group called for the NIH action, claiming that Pfizer failed to make Xalatan available to the public on reasonable terms. Pfizer allegedly charges U.S. consumers between two to five times more for Xalatan than it charges Canadian and European consumers. The NIH is taking the position that the march-in proceeding isn't warranted in part because the product has been available for use by glaucoma patients since 1996 and is being actively marketed by Pfizer and prescribed by physicians.

Contact lens wearers not likely to mention end of day discomfort
In a recent VISTAKON survey of vision-corrected consumers, 63 percent of contact lens wearers reported some end-of-day discomfort from wearing contact lenses. The most common symptoms were eye dryness and lenses not feeling as comfortable as they did when first put in. Those experiencing discomfort attributed it to a variety of reasons, such as wearing contact lenses for too long, lack of sleep, windy environment, climate, and cigarette smoke. However, less than a third told their Eye Care Professional about the discomfort problem, underscoring the importance of asking specific probing questions to uncover real issues among seemingly happy patients.
Address end of day discomfort by prescribing ACUVUE ADVANCE with HYDRACLEAR. You'll exceed patients' expectations and hopefully keep them in contact lenses longer. (http://www.ecp.acuvue.com)
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Optical Connection Opens New Facility
Optical Connection, Inc. has opened a new facility in San Diego that will be the home for the manufacturing operations of its highly advanced WaveTouchProcess used in the fabrication of the soon-to-be launched iZon by Definition FRP soft contact lenses. According to the company, iZon by Definition FRP lenses are the result of in-office aberrometry readings virtually linking the Wavefront data with the company's high-speed contact lens manufacturing system. "The iZon by Definition FRP lenses will allow each patient to achieve a highly individualized contact lens answer to their specific visual needs," says Vincent Zuccaro, O.D., president and CEO of Optical Connection, Inc. In other company news, David Israel joins the Optical Connection team as senior vice president of Business Development/Operations.

PreserVision Improved
Bausch & Lomb is introducing two new soft gel versions of its patented eye health nutritional supplement, PreserVision, for age-related macular degeneration. PreserVision AREDS Formula is an easy-to-swallow supplement designed for patients to take it b.i.d. The company says it delivers the same levels of vitamins and minerals and all of the health benefits as the original four-tablet-a-day formula. PreserVision Soft Gels Lutein Formula, with the same easy-to-swallow, b.i.d. dosing, contains lutein to promote general eye health.

Abstract: Factors in Corneal Iron Ring Formation
Researchers report on a case of a 31-year-old man who underwent overnight orthokeratology with GP contact lenses of reverse geometry design to correct myopia. The patient's prefitting manifest refraction was -4.75 -0.25 x 175 OD and -4.50 -0.25 x 175 OS. No corneal abnormality was detected until nine months after treatment and development of corneal arcuate lines in both eyes was observed at the one-year follow-up visit. The patient's visual acuity wasn't affected and the deposition pattern corresponded to the outside border of central flatter zone. The researchers concluded that the current findings suggest that tear pooling between the corneal surface and the back surface of the contact lens plays a role in the development of corneal iron ring after ortho-k with reverse-geometry contact lenses.
Hiraoka T, Furuya A, Matsumoto Y, Okamoto F, Fakita T, Oshika T. Corneal Iron Ring Formation Associated With Overnight Orthokeratology Cornea 2004 Nov;23(8):S78-S81.
Editor's Note: This is the third or fourth such publication on this finding that we are aware of, but there seems to be no adverse effect for the patient and it resolves when the patient discontinues lens wear.

Editor's Commentary: Contact Lens Practice is a Great Opportunity
A recent American Optometric Association (AOA) news article indicates that more than 75% of patients seen in O.D. practices have third-party and managed care plans. A graphic in the same article illustrates that 35% of revenue generated comes from patients out-of-pocket payments. I think it's likely that much of this out-of-pocket revenue, perhaps 20% to 30% or more comes from contact lens services and contact lenses themselves. Sure, there's a lot of competition for contact lens services and sales, but most of these contact lens patients contribute to practice revenue with private pay as well as insurance payment. And new products, which provide better health and safety and performance, add value and contribute to practice revenue.

Fitting Tip: Wearing Schedules
Wearing schedules seem to be a difficult subject. I have been fitting one particular daily wear lens for about seven years now. It was originally designed and marketed for two to four weeks of wear. After another company bought the lens, the wearing schedule has only been two weeks. I have seen absolutely no problem with this lens on monthly replacement and continue to prescribe it this way. My point is that contact lens manufacturers can contribute to the wearing schedule confusion, which makes it difficult to explain to a patient why you want him to wear some lenses for two weeks, but similar lenses for only one month. I would like to see some discussion about this topic.
--Christopher Howard, O.D.
Crestview, Fla.

Report adverse contact lens reactions here: http://www.accessdata.fda.gov/scripts/medwatch/ or call (800) FDA-1088.

Access a reporting form for complications you've seen that were a result of contact lenses dispensed without a valid prescription at the Association of Regulatory Boards of Optometry's (ARBO's) Web site: http://www.arbo.org/arbo.asp?dt=R&doc=Complications. Complete and send the form online or print it out and fax it to (866) 886-6164.

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