At Press Time

FDA Begins LASIK Outcomes Study

"Quality-of-Life" Issues to be Examined.

By Jerry Helzner, Senior Editor

■ Until now, the FDA's position on LASIK has been that despite a small percentage of dissatisfied patients, the vast majority of individuals who have undergone the procedure were satisfied with their outcomes.

However, the FDA now believes that it needs more data to accurately quantify "quality-of-life" (QOL) issues after LASIK. These issues have been consistently raised by dissatisfied LASIK patients, many of whom have been highly vocal and explicit about the problems LASIK caused in their own lives. The new data will help the FDA more accurately evaluate the specific reasons and causes for their unhappiness.

Toward this end, the FDA has solicited the cooperation of the National Eye Institute (NEI), the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgeons to form the LASIK Study Task Force. The Task Force is currently designing a national clinical trial to investigate QOL after LASIK. The study will enlist the help of refractive surgeons across the country.

In addition, the FDA's Ophthalmic Devices Advisory Committee is beginning a discussion of what the FDA describes as "general issues concerning the post-market experience" pertaining to equipment used in performing LASIK and also to phakic IOLs. It is not yet known whether this discussion will also focus on LASIK outcomes compared to various surface ablation procedures and/or procedures that use a femtosecond laser to cut the flap.

"Before we can form an opinion on the subject we need data," an FDA spokesperson told Ophthalmology Management. "In fact, back in 2006, in response to consumer complaints about quality-of-life following LASIK surgery, the FDA re-evaluated symptom and QOL data submitted with the premarket approval applications for LASIK lasers and also scrutinized the existing medical literature. As a result of this review, we noted that the available clinical data failed to suggest significant problems following LASIK surgery. A small percentage of patients were dissatisfied; the vast majority of patients were satisfied with their outcomes. We also noted that QOL issues related to LASIK had not been evaluated consistently and there were few reports of well-designed studies of QOL post-LASIK."

The new, large-scale study is designed to provide the data to more accurately evaluate QOL issues related to LASIK. As a preliminary step of this project, a pilot study is currently under way at the NEI Clinical Center. This pilot will assist FDA and NEI to further develop adequate tools for the assessment of QOL related to ophthalmic outcomes.

Novartis Buying Minority Stake in Alcon

Two-Step Deal Could Make Novartis Majority Owner in 2010.

By Jerry Helzner, Senior Editor

■ After hinting for months that Alcon is essentially an investment and not part of its long-term strategic plans, Swiss coffee, food and confectionery giant Nestlé is selling a 24.85% stake in the eyecare company to Novartis for $11 billion. Nestlé is also giving the diversified pharmaceutical company an option to purchase its remaining 52% of Alcon for approximately $28 billion in 2010.

For Nestlé, the deal provides needed capital to pay off debt, buy back its own shares and expand its core international food business, which already includes such brands as Nescafe coffee, Perrier water, Stouffer's frozen foods, Purina pet foods and Butterfingers candy bars. A large stake in Alcon will allow Novartis to expand its presence in the high-growth eye care area, where the company already has the CIBA Vision contact lens business and international rights to two drugs for the treatment of wet AMD, Lucentis and Visudyne.

"Eye care will continue to grow dynamically as there is a growing unmet medical need driven primarily by the world's aging population," said Novartis CEO Daniel L. Vasella, M.D. "The margins are higher than our pharma business and are obviously very attractive."

"I welcome Novartis as a minority investor, and I believe the agreement validates Alcon's leadership and bright future in the attractive and growing eye care market," said Cary Rayment, Alcon's chairman, president and chief executive officer. "It is also a testament to all of our employees who have been responsible for making Alcon the global leader in the eye care market."

Nestlé purchased Alcon in 1977 when Alcon had only about $80 million in annual sales. By all accounts, Nestlé has been a benign and nurturing parent. Alcon was able to operate as a quasi-independent company under the Nestlé umbrella, probably because Nestlé senior management was made up of "food people" who understood that they didn't possess the specialized, day-to-day knowledge required to operate and grow a major vision care business.

In March of 2002, Alcon became a publicly traded company when Nestlé sold approximately 23% of its stake in the company for more than $2 billion through an initial public offering (IPO) at $33 a share. Since then, Alcon shares have skyrocketed as the company continued to record impressive growth through its wide array of medical, surgical and consumer eyecare products. On the Friday before the Novartis deal was announced, Alcon shares traded at just above $148 a share. Novartis was able to buy the initial 24.85% stake for about $143 a share. The lower price was considered justified as it ends the uncertainty regarding Nestlé's plans for Alcon and removes a large overhanging block of Alcon shares from the market.

Alcon Chairman and CEO Cary R. Rayment

Nestlé chairman and chief executive Peter Brabeck-Letmathe said the deal was good for his company's shareholders and would give Alcon a new minority shareholder "whose activities are closely aligned with its own business."

A Nestlé spokesman said the deal should not lead to job cuts.

"I don't suspect it will have any measurable impact on the human resources of Alcon, especially since they are active in areas in which Novartis quite obviously isn't," he said.

Nestlé and Novartis are apparently quite comfortable in dealing with each other. Both companies are based in Switzerland and last year Novartis sold Nestlé its Gerber baby food business for $8 billion.

The deal is subject to regulatory approval.

GIVING BACK:

Dr. Arendshorst Finds His Mission

Leading a More Fulfilled Life by Restoring Sight.

By Leslie Goldberg, Associate Editor

■ John Arendshorst, M.D., who practices ophthalmology at the Holland Eye Surgery and Laser Center in Holland, Mich., was at the point in his career where he was able to look past the tasks of running a daily practice and yearned to reach out and do something for the global community.

In his quest to locate the right outlet, he found SEE International, a nonprofit humanitarian organization that provides medical, surgical and educational services by volunteer ophthalmic surgeons, with the primary objective of restoring sight to disadvantaged blind individuals throughout the world.

Although he made his first trip to Tonga without his wife Nicki, she has accompanied him on his subsequent trips to India. "I bring her not only because we need the extra help, but because this is a thought-changing experience and I think we should experience it together," says Dr Arendshorst.

Dr. Arendshorst explains that SEE's model is to have a host doctor present where the affiliate ophthalmologist is going to be performing surgery. "Either the host doctor will travel to where you are going or you go to where the host doctor is from," explains Dr. Arendshorst. "The areas in India where I have practiced have some infrastructure, although at times it can be intermittent and fragile. The host doctor and volunteers organize a patient plan, provide you with sleeping accommodations and some kind of operating theater environment that will be conducive to getting the job done. This involves a tremendous and impressive volunteer effort.

"When you arrive at your destination with all of the supplies that SEE helps to collect — equipment and disposable surgery supplies, a surgical microscope, etc. — the host and his assistants work towards helping you make the largest impact possible during the time you spend there."

Dr. Arendshorst says that SEE tries to work with people in locations where the host doctor has requested the need for a surgeon. The host organizes local and medical eye support to form an eye camp, which requires a highly integrated effort.

Postoperative cataract patients at an eye camp in India.

"We bring our skills, but typically the host doctors are excellent clinicians and surgeons in their own right," says Dr. Arendshorst. "We do more of a cultural exchange of things. We compare how we each handle different situations and problem-solve together."

The biggest hurdle is adapting to the conditions in which they are working. Dr. Arendshorst says that the operations performed are less techno-intensive. For example, he sees cataracts that are much more dense and actually blinding. "The techniques we use at home are quite different than the ones needed in these situations," says Dr. Arendshorst. "You need to perform cataract surgery similar to the way it was done 30 years ago. You have to alter your surgical performance to meet the needs of these dense cataracts. You are not able to work with a large amount of disposable supplies. The cataracts we see in the host countries are not amenable to today's way of performing cataract surgery."

Dr. Arendshorst says he and his wife are usually in the host country for about a week. "You get into the rhythm in the OR because you are standing for 5 hours at a stretch," he says. "You operate from morning into the night or later. Often, patients come from as far as 150 kilometers away. You endure the long hours and get exhausted but when you're done you're left wondering when you can return."

Dr. Arendshorst says that the level of patient gratitude is extremely high. Some cataract patients have not seen their family members for many years because they have been blinded, and because of their visual disability, are unable to be productive members of their family.

"They become an encumbrance," he says. "And what we do helps them become productive again. There is an altruistic instinct that makes people want to get something done. This situation brings out good things in people. It has enforced the realization that people are more similar than they are different."

For more information on SEE International, visit their Web site at www.seeintl.org.