Article Date: 11/1/2009

Looking Closer at LASIK
NEWS spectrum

Looking Closer at LASIK

The U.S. Food and Drug Administration (FDA) has announced the launch of a collaborative study with the National Eye Institute and the U.S. Department of Defense to examine the potential impact on quality of life from LASIK. According to the FDA, the goal of the LASIK Quality of Life Collaboration Project is to determine the percentage of patients who have significant quality of life problems after LASIK surgery and to identify predictors of these problems.

Funded by the National Eye Institute and the Department of Defense, the project is composed of three phases. Phase 1 began in July 2009, and its objective is to design and implement a Web-based questionnaire to assess patient-reported outcomes and to evaluate quality of life issues post-LASIK, some of which may relate to the safety of the lasers used in the LASIK procedure. Phase 2 will evaluate the quality of life and satisfaction following LASIK as reported by patients in a select, active duty population treated at the Navy Refractive Surgery Center. Phase 3 will be a national, multicenter clinical trial to study the impact of LASIK on quality of life following the procedure in the general population. Patient enrollment in Phases 2 and 3 have yet to begin, but plans are underway. Phase 3 is expected to end in 2012.

The FDA says that the results of the project will help identify factors that can affect quality of life following LASIK as well as potentially reduce the risk of adverse effects that can impact the surgical outcome. If any of these factors relates to the safety or effectiveness of the lasers used in the procedure, the FDA will evaluate whether any action is necessary. The project is part of the FDA's ongoing effort to better monitor and improve the safety and effectiveness of the lasers used in LASIK surgery.

"This study will enhance our understanding of the risks of LASIK and could lead to a reduction in patients who experience adverse effects from the procedure," said Dr. Jeffrey Shuren, Acting Director of the FDA's Center for Devices and Radiological Health.

AOS Expands Advocacy

The American Optometric Society (AOS) recently formed to advocate for transparency and fair representation within optometric organizations. With nearly 1,500 members at press time, the AOS has expanded its mandate beyond its initial but still primary missions of opposing American Optometric Association/American Board of Optometry "board certification" and facilitating fair representation within local and state optometric associations.

"The AOS has quickly evolved to encompass more than the board certification issue and the denial of fair representation at the AOA House of Delegates," said AOS President Dr. Pam Miller. "We have expanded our mandate to include working with other organizations toward uniform national licensure, broader access to insurance programs and broad inclusion in healthcare reform."

The AOS welcomes new members and along with its broader focus has also launched a new Web site at www.optometricsociety.org. Commenting on the site's launch, Dr. Miller remarked, "The organization has reached an important milestone. With our new site we can now more effectively connect with our existing members and sign up new members online."

Foundation for Eye Health Forms

The Core Planning Team of the Eye Health Summit has announced the formation of the Health Eyes for Life Foundation. Created to increase the public's awareness about the importance of eye health, the foundation will develop a nationwide messaging campaign that directs people to take better care of their eyes.

Jim Anderson, attorney for Anderson, Howe and Steyer, has been appointed acting chairman of the organization. An interim board of directors includes Barry Barresi, OD, American Optometric Association; Edward Green, The Vision Council; Tom Hicks, Opticians Association of America; Steve Ingram, National Association of Vision Care Plans; Wally Lovejoy, Luxottica Retail; Greg Marko, Transitions Optical; Daniel Monaco, Essilor; Stan Rogaski, Contact Lens Institute; Dave Sattler, Alcon Labs; and Jeff Todd, Prevent Blindness America.

For the remainder of 2009, the Healthy Eyes for Life Foundation will continue communicating with Summit attendees, conduct an executive management search, and create a foundation identity, brand, and key marketing pieces. In 2010, the foundation will develop messaging and conduct a search for a creative agency. A foundation brand and partner guidelines will also be created, and the campaign will be launched to the vision community. A consumer launch is anticipated in 2011.

Survey Shows Declining Visits

Many consumers continue to struggle with financial challenges that are causing them to limit their visits to healthcare professionals, according to a survey released by the American Optometric Association (AOA).

When asked which doctors they are visiting less, the majority indicated dentist (63 percent), followed by primary care physician (59 percent) and eye doctor (52 percent). Only 8 percent indicated that they are sticking to their regular health schedule.

Dr. David Cockrell, optometrist and AOA Trustee, says, "We know that many eye and vision problems have no obvious signs or symptoms, so early diagnosis and treatment are critical."

While the survey did not ask why respondents chose to make specific cutbacks in doctor visits, fear of losing eyesight is likely part of the answer. For the fourth year in a row, the AOA's American Eye-Q survey showed that consumers worry most about losing their vision (43 percent), over their memory (32 percent) or even their ability to walk (12 percent).

Dr. Cockrell said that putting off doctor visits ultimately can be more expensive and lead to additional health problems. "The longer patients go between doctor visits, the greater the opportunity for additional health problems that ultimately can be much more expensive than routine checkups and early-stage treatment. That is another reason that identifying health problems in the early stages is ideal."

INDUSTRY BRIEFS
■ A study in the July issue of Eye and Contact Lens indicates that a high proportion of Singaporean children requiring vision correction are able to successfully wear daily disposable contact lenses over a three-month period. The research, following a protocol similar to the Contact Lens in Pediatrics (CLIP) study in the United States, evaluated the safety, efficacy, and physiologic performance of daily disposable soft lenses (Vistakon's 1-Day Acuvue and 1-Day Acuvue for Astigmatism) in Singaporean children ages 8 to 12 years old. Researchers report that most of the subjects, as well as their parents, preferred contact lenses to spectacles across a wide variety of aspects, including vision, comfort, handling, and appearance, and that overall vision quality, overall comfort, and end-of-day comfort were graded significantly better at each of the follow-up visits compared with baseline spectacles (p≤0.0001).

Lux Biosciences, Inc., a privately held biotechnology company focused on the treatment of ophthalmic diseases, has announced results from a Phase 1 human safety and an open-label pilot efficacy study of the company's potential best-in-class therapy for dry eye, LX214 (topical mixed nanomicellar formulation of voclosporin). Randomized, doublemasked, placebo-controlled data from 30 healthy volunteers showed LX214 to be well tolerated at the two doses (0.02% and 0.2%) studied, with safety and tolerability measurements (pain, burning, reddening, photophobia, foreign body sensation, and others) indistinguishable from placebo.

Bausch & Lomb recently announced that it has acquired the commercial assets of Tubilux Pharma S.p.A., a privately held ophthalmic pharmaceuticals company that develops and markets a range of proprietary, over-thecounter, and branded generic products primarily in Italy, and with distribution in approximately 30 other countries. Under the terms of the agreement, B&L has acquired the company's ophthalmic pharmaceuticals portfolio, as well as commercial and sales operations. Group Tubilux will retain its manufacturing operation, producing existing products for B&L under a multi-year contract.

Odyssey Medical reports a 92 percent retention rate for its Parasol Punctal Occluder. In a recent study, Dr. Craig McCabe examined 108 patients who had failed on artifical tears and received the Parasol Punctal Occluder. In addition to the retention results, 91 percent of patients reported that their eyes had more moisture, and 77 percent stated fewer dry eye symptoms.

I-Therapeutix, Inc. recently announced that it has changed its corporate name to Ocular Therapeutix, Inc. The company has also launched a new Web site at www.ocutx.com.

Bausch & Lomb has announced that several of its pharmaceuticals subsidiaries have been granted rights from Croma Pharma GmbH to co-promote and sell bromfenac ophthalmic solution in Europe when it becomes available to market. Bromfenac, a non-steriodal anti-inflammatory drug, is designed to treat post-op ocular inflammation and pain following cataract extraction.

■ Canadian officials are funding a new $6.7-million research network to deal with the increasing vision loss of Canadians. The 20/20 Network will focus on developing and commercializing new biomaterials, medical devices, and drug delivery devices for treating vision disorders. Some of the products being pursued include: composite and hybrid materials; ocular microgels, microemulsions and triggerable materials for drug release; a drug delivery system that attaches to the back of the eye to eliminate monthly needle injections; and contact lenses that eliminate end-of-day dryness and discomfort.

USA Today featured a supplement on vision care that appeared with the Oct. 2 issue in most major U.S. markets (New York; Los Angeles; Chicago; Dallas; Washington, DC; Baltimore, MD; North Carolina; and South Carolina). More than one million copies are in circulation, and the supplement, "Vision: Your Guide to Vision Care and Eye Health," is also available online. The 16-page supplement contained information on soft and GP lenses, lens care, corneal reshaping, glaucoma, low vision, the importance of UV protection, and the importance of regular eye exams.

INFORMATION FOR ALLERGY SUFFERERS AVAILABLE
■ The Asthma and Allergy Foundation of America (AAFA) is offering a free educational brochure titled "Eye Health and Allergies." The brochure, supported by 1-Day Acuvue Moist (Vistakon), includes allergy season advice for the nation's 40 million contact lens wearers.
The brochure can be downloaded at www.AllergyCapitals.com. By visiting the Web site, people can learn if their city is an Allergy Capital and get information about allergy symptoms, how to avoid triggers, and how to best treat their symptoms. The top five most challenging cities for allergy sufferers this year are: McAllen, Texas; Wichita, Kan.; Louisville, Ky.; Oklahoma City, Okla.; and Jackson, Miss.
In addition, according to a recent AAFA survey, fall is also one of the most troublesome times of year for people who have eye allergies. In the survey, nearly one-third (29 percent) of respondents said that they experience eye allergy symptoms in autumn.

International Vision Expo West Exceeds Expectations
Preliminary unaudited attendance figures for International Vision Expo West, held last month from Oct. 1 to 3 at the Sands Expo and Convention Center in Las Vegas, indicate that 11,758 eyecare professionals attended, which is down 6 percent from 2008 preliminary unaudited attendance. The continuing education program drew 3,873 eyecare professionals, while 7,885 attendees visited the exhibit hall. "Given today's economy, we are extremely pleased with these preliminary numbers," said Tom Loughran, event director for Reed Exhibitions.
Next year, the conference for International Vision Expo West will be held Oct. 6 to 9, 2010, and the exhibition will be held Oct. 7 to 9, 2010, at the Sands Expo and Convention Center in Las Vegas. International Vision Expo West has show dates confirmed with the Sands Expo and Convention Center through 2012 and will continue to hold the event each year in the September/October timeframe.

WEB UPDATE
CooperVision Launches LensLocator

CooperVision has introduced its LensLocator at www.LensLocator.com, an online tool that allows practitioners to enter a patient's prescription — or a component of a prescription — and search across CooperVision's portfolio of lenses to quickly identify the most appropriate choices. The search tool also works with Web-capable smart phones. To help kick off the new site, Cooper-Vision will be donating a dollar to New Eyes for the Needy for each unique visitor to LensLocator.com, up to $5,000. Endorsed by the American Academy of Optometry, New Eyes for the Needy is a non-profit volunteer organization that provides new and recycled eyeglasses to children and adults worldwide.

B&L Launches Enhanced eCommerce Site

Bausch & Lomb has released its enhanced U.S. eCommerce Web site at www.bauschonline.com. Since the site's original launch in 2005, B&L has collected input from active users to improve its online ordering functionalities. The newly enhanced site includes a new, interactive dashboard where customers can view a summary of items currently in their cart and their 10 most recent orders; simplified ordering for contact lens types, order types, as well as delivery preference; one-click access to check the status of orders and to track shipments; and improved order history and search capability.

For the Record
In the October 2009 article, "The SMART Study: Background, Rationale, and Baseline Results," by S. Barry Eiden, OD, FAAO; Robert L. Davis, OD, FAAO; Edward S. Bennett, OD, MSEd, FAAO; and Julie O. DeKinder, OD, FAAO, the study lens material is Boston Equalens II (Bausch & Lomb) rather than Boston XO as stated in the article. Boston XO is not FDA approved for overnight wear.


Contact Lens Spectrum, Issue: November 2009