at press time

The Man Behind Macugen
OSI's Goddard Relishes the Underdog Role.

OSI CEO Colin Goddard, Ph.D.

Colin Goddard, Ph.D., was for 7 years the little-known CEO of OSI Pharmaceuticals, a growing biotech company with a promising new cancer drug in Tarceva. Then, last August, he dropped a bombshell that shocked Wall Street.

The 45-year-old British-born executive with the confident manner and candid speaking style announced that OSI had agreed to buy Eyetech Pharmaceuticals, the developer of Macugen for the treatment of wet AMD, for about $650 million in cash and stock. OSI shares then began a sharp plunge that eventually took the stock from 40 to as low as 20. It has since recovered a significant percentage of that loss.

The sharp drop in OSI shares reflected a growing belief in the investment community that Genentech's investigational drug for wet AMD, Lucentis, was capable of actually improving vision rather than just halting or slowing the progression of wet AMD, which Macugen does in most patients. Results from pivotal phase 3 trials indicated that Lucentis was clearly the more efficacious drug.

In defending the Eyetech deal, Dr. Goddard initially said the acquisition could be profitable for OSI even if Macugen only retained 10% of the wet AMD market and be found useful in other indications such as diabetic macular edema.

More recently, Dr. Goddard has outlined a much bolder strategy for Macugen in wet AMD, emphasizing comparative safety data that he says makes Macugen the best choice for newly diagnosed patients without severe vision loss, those at-risk for coronary disease and strokes, and as a maintenance therapy following the use of either Lucentis or Avastin in the acute phase.

Since the announcement of the Eyetech purchase, Dr. Goddard has been fighting an uphill battle. He has had to deal with angry OSI stockholders who have forced the company to agree to put all future major acquisitions to a shareholder vote. He has had to deal with doubters on Wall Street. He has also had to deal with some retina specialists who do not share his vision for the future of Macugen.

Dr. Goddard seems to be relishing the underdog role. In his frequent public appearances, he strongly and confidently emphasizes Macugen's stellar safety record. He has pushed the idea of a "one-two punch" against wet AMD through a combination of Lucentis or Avastin followed by Macugen maintenance. He is moving quickly to develop a sustained-release version of Macugen.

After 17 years with OSI Pharmaceuticals, Dr. Goddard, who trained as a cancer pharmacologist, appears to be the unquestioned leader and voice of his company.

Dr. Colin Goddard is clearly an important new presence in the eyecare industry. Whether his bold moves will pay off will be one of the more interesting stories of the next few years.

GIVING BACK: Dr. Butner Takes on Tough Assignments
He has helped in Bosnia, Iraq and Afghanistan.
By Jerry Helzner, Senior Editor

Dr. Robert Butner examines a young patient in Sarajevo, Bosnia.

The travel itinerary of Robert W. Butner, M.D., over the last two decades is more befitting of a war correspondent than a retina specialist.

Working with the American Academy of Ophthalmology (AAO) Volunteer Registry, the tough Texan has volunteered his services in such hot spots as Bosnia, Afghanistan and Iraq. He has also managed to fit in trips to Bulgaria, Romania, Albania and Mongolia.

In Sarajevo, Bosnia, he worked in a hospital in 1993 that was under daily artillery fire from the Bosnian Serbs in the hills above the city.

"Fortunately, there was a two-story building in front of the hospital that provided some shelter," he says. "We could work on the bottom floors of the hospital fairly safely. If I had any close calls, I really don't remember them."

Dr. Butner's casual approach to danger can be expected of a man who served 23 years in the military, exclusively in parachute units. He has made more than 100 military parachute jumps and, at the age of 63, enjoys competing in military parachuting around the world.

"That's my idea of fun," he says.

First Stop, Bulgaria

Providing eye care to an elderly Afghan in a Kabul hospital in 2003.

Dr. Butner, who today is clinical assistant professor of ophthalmology at the University of Texas, Houston Medical School, first felt the call to volunteer after the fall of the Berlin Wall in 1989. He watched television coverage of the wall being torn down and felt that he should be doing something to help. Fortunately, the end of the Soviet regime meant that American retina specialists were needed as teachers.

"When the communist bloc broke up, Russia stopped providing instructors to teach new retina specialists in countries like Bulgaria and Romania," he notes. "When I saw there was a need for volunteers who were retina specialists, I went."

Dr. Butner's first assignment was in Sofia, Bulgaria, where he worked in The Institute for the Treatment of Foreign Citizens, a facility that provided the most advanced eye care in the country.

"I taught the Bulgarian ophthalmologists the techniques of our style of retina surgery, including the use of the indirect ophthalmoscope for retinal detachments and retinal diagnoses," he notes. "The Russians had never taught them how to use the indirect ophthalmoscope, so I guess you can say that's my contribution to Bulgarian ophthalmology."

In Sarajevo, a formerly beautiful city that had been the site of the 1984 Winter Olympic Games, Dr. Butner routinely dealt with snipers and shellfire.

"In Sarajevo, they had converted the Olympic stadiums to graveyards," he says. "But the hospital staff was very helpful. They would tell me where it was safe to walk and when we could move around. The biggest adventure was at the airport, where the Bosnian Moslems controlled the runway and the Bosnian Serbs controlled the hills around the airport. You were basically taking evasive action on both landings and takeoffs."

Afghan colleagues examine a patient in a Kabul hospital in 2003.

Afghanistan and Iraq

Dr. Butner says one of his best experiences was in Kabul, Afghanistan, after the Taliban had been overthrown.

"It was really uplifting to teach there," he says. "The Taliban had banned music, so there was music blasting everywhere. There was a real sense of liberation."

In 2004, in Baghdad, Dr. Butner participated in a joint United States/Iraqi medical meeting.

"We stayed in trailers in the Green Zone, which is the safest part of Baghdad. "I would like to go back there."

Last year, Dr. Butner got to spend 2 weeks in Mongolia, teaching local ophthalmologists at Hospital Number 1.

"Everyone under 40 speaks English, so it was no problem communicating,' says Dr. Butner. "With the older patients, I learned enough Mongolian to give them directions such as 'Look up. Look down.' It was one of my most enjoyable assignments."

In Houston, Dr. Butner has a practice that is about half private patients and half charity cases.

Dr. Butner (at right) with a U.N. official in besieged Sarajevo in 1993.

"It's the ideal practice because I get to deal with a variety of retinal problems, ranging from AMD to some exotic conditions," he notes.

Dr. Butner is married to an attorney who has her own active career.

"She puts up with my absences," he laughs. "She has a lot to keep her busy."

Dr. Butner received the AAO Humanitarian Award in 2001 for his volunteer efforts, and particularly for his work in Bosnia.

"I guess it was because I wanted to go to places that no one else was too interested in going to."

Ophthalmology Management recently initiated a new feature — Giving Back — which highlights the work of ophthalmologists who devote a significant amount of their time to volunteering their skills in behalf of humanitarian efforts. In an effort to identify and recognize the work of these largely unsung heroes, Ophthalmology Management has been working with the American Academy of Ophthalmology and the American Society for Cataract and Refractive Surgery. We also welcome suggestions from our readers. If you know of an ophthalmologist who deserves recognition in Giving Back, please e-mail basic information to Jerry Helzner at helznergi@LWWVisionCare.com or call (215)-643-8013.

Guest Editorial
Provide a Tax Credit for RLE
Reduce Medicare's Reimbursement Burden.
By R. Bruce Wallace III, M.D.

An increasingly strained Medicare reimbursement system and the future eye care needs of tens of millions of aging baby boomers are on a collision course.

If there is anything as certain as death and taxes, it is that about 60% of seniors will develop vision-threatening cataracts that require surgical removal. Medicare code 66984, cataract removal with implantation of intraocular lens, is the single most common procedure covered under Medicare.

According to Michael Romansky of the Outpatient Ophthalmic Surgery Society, the consensus in the eyecare community is that about three million such procedures are expected to be performed in the United States this year. At an average reimbursement of about $1,500 per procedure, split between the physician and the facility in which the procedure is performed, Medicare will probably pay out more than $4 billion in reimbursement for cataract surgeries in 2006. That does not include other payments for the examinations and A-scans associated with routine cataract surgery. With the vanguard of almost 80 million baby boomers just turning 60 this year, the number of cataract surgeries performed each year will be increasing at an alarming rate over the next two decades.

But recent advances in IOLs are allowing people in their 40s, 50s and 60s to avoid the possibility of ever having cataracts — and ever needing cataract surgery.

Three major eyecare companies, Alcon, Advanced Medical Optics and eyeonics, have each recently developed advanced IOL designs that have proven in clinical trials that they can deliver good, spectacle-free vision at near, intermediate and far distances to most people who have these lenses implanted. Innovative surgeons, led by Richard Lindstrom, M.D., of Minnesota Eye Consultants, have even gone a step further by "mixing and matching" these lenses in various combination to produce better vision for specific patients. In other words, an Alcon ReSTOR lens may be implanted in one eye for better near vision and an Advanced Medical Optics' ReZoom lens in the other for better intermediate and distance vision. Or, alternatively, an eyeonics crystalens may be the best choice for one of the eyes.

These new lenses are now FDA-approved and available. Beginning last year, cataract surgery patients have the option of having these lenses implanted in their eyes if they pay the additional costs associated with the advanced lenses (Medicare still reimburses for the basic procedure).

But of even greater interest is the fact that the authoritative ophthalmology newsletter MarketScope estimates that 30,000 to 40,000 people last year chose refractive lens exchange (RLE) even before they had developed cataracts. As you know, with RLE the natural crystalline lens is removed from each eye and usually replaced with
either a "multifocal" ReSTOR or ReZoom lens, or an "accommodative" crystalens.

The great majority of people who choose to have RLE, almost all of whom are over 45, can look forward to spectacle-free vision with no possibility of ever developing cataracts, though a small percentage of those who opt for RLE will require reading glasses.

Because every person who undergoes RLE is one less person likely to need Medicare-reimbursed cataract surgery, it is reasonable to assume that individuals who choose RLE are doing both themselves — and the federal government — a favor. Is it too wild an idea to propose that the federal government offer a modest tax credit for RLE, say $750, to encourage greater adoption of this procedure, which comes with an out-of-pocket cost of $5,000 to $6,000 to the individual? The precedent is already set. Private health insurers offer financial incentives for individuals who take part in preventive-care "wellness" programs. The government offers tax credits to individuals who purchase the highly fuel-efficient hybrid cars.

It is going to take some out-of-the-box thinking to keep Medicare viable against the onslaught of increasing baby boomer healthcare needs. A proactive baby step to reduce the number of Medicare-reimbursed cataract surgeries is just one way to stimulate more creative approaches to this looming problem.

R. Bruce Wallace III, M.D., is medical director of Wallace Eye Surgery in Alexandria, La., clinical professor of ophthalmology at LSU New Orleans, and associate clinical professor of ophthalmology at Tulane University. He has had extensive experience in performing RLE.

IN THE NEWS

►Lucentis priority review. The FDA has accepted the Biologics License Application (BLA) for the use of Lucentis in the treatment of wet AMD. As part of the BLA filing, Lucentis developer Genentech requested and has been granted a 6-month Priority Review.

The FDA has 6 months from the submission date, or by the end of June, to take action on the filing.

In addition, Genentech said that preliminary 2-year data from the phase 3 MARINA study showed that the improvement in the Lucentis groups at year 1 was maintained at year 2 as measured by visual acuity endpoints, while there was further deterioration of vision among patients in the control group. The difference between mean visual acuity in the Lucentis arms and the control arm increased at year 2 compared to year 1.

At least 90% of patients treated with Lucentis maintained (defined as a loss of less than 15 letters in visual acuity) or improved (defined as a gain of more than 15 letters in visual acuity) vision compared to approximately 53% of those treated in the control arm at year 2.

►AMO supports lenticular research. Advanced Medical Optics (AMO) has pledged $1 million to support American Society of Cataract and Refractive Surgery (ASCRS) Foundation-sponsored research in refractive lenticular science. The announcement was made at the recent ASCRS meeting by I. Howard Fine, M.D., ASCRS Foundation Chairman.

"In 2006, we will begin work on a substantial multi-year program to support new research and educational programs that explore the rapidly emerging science of refractive lenticular surgery," said Dr. Fine. "Ophthalmology stands on the edge of an exciting new future and the changes we will experience during the next few years will be exponential. The established paradigm of a single, government-funded provider of eye care is quickly giving way to patient-driven, multivariant options. What we have seen to date represents only the first timid steps into a new world of opportunity. In the coming years, the ever-increasing merger of cataract and laser refractive science will change our practices and greatly increase what we can offer our patients."

"Our goal as founding sponsor of this program is to grow awareness and understanding of lenticular and corneal refractive science," said James V. Mazzo, president and CEO of AMO. "This includes the development of programs designed to promote both physician and public education programs, including best marketing and patient selection practices. As we heard from Dr. Stephen Lane during his Binkhorst Medal Lectrure at the ASCRS opening session, patient selection and education will be critically important to the long-term success of these technologies."

►IntraLase in corneal transplants. IntraLase Corp. said the first corneal transplant cases using the IntraLase FS laser have been successfully performed in patients, which the company said marks a major technology advancement in corneal transplant surgery.

IntraLase says use of its ultra-fast laser to create a contoured, full-thickness corneal resection in preparation for corneal transplant has the potential to make corneal transplantation a safer, more precise procedure as the all-laser approach gains favor among transplant surgeons. Full global launch of this new therapeutic application is expected this fall.