at press time

Aging Boomers Need More Eye Care
AAO/AAOE Seek to Help Practices Become More Efficient.

The American Academy of Ophthalmology has embarked on a major effort to help prepare its members for the huge cohort of baby boomers, the first of whom turned 60 this year.

The Academy and the American Academy of Ophthalmic Executives (AAOE), a partner organization, are developing a database to collect information from ophthalmology practices in more than 25 standardized areas, covering financial and staffing measures, as well as the number of patients seen.

The practice benchmarking database, which will debut at the Academy's Joint Meeting in November in Las Vegas, represents the most ambitious data-collection and data-sharing efforts within ophthalmology.

"The challenge is to make it easy for practices to compile and enter standardized data, and then use that data to compare their performance with that of similar practices — by subspecialty, practice size, location and more," said David W. Parke II, M.D., the Academy's senior secretary for ophthalmic practice. "By knowing where they stand now, ophthalmologists can then consider whether and how to modify their practices to improve efficiency."

The practice benchmarking database is the first recommendation from a task force convened more than 2 years ago by the Academy to assess the future of eyecare delivery and how it will be affected by the age wave and other demographic trends, health care economics, technological innovation, medical education and more.

The age wave — a projected 50% increase in the U.S. senior population between 2000 and 2020, according to the U.S. Census Bureau — will significantly affect the health care industry, particularly ophthalmologists, who on average spend more than half of their time treating older patients.

"What we know is that ophthalmology must be ready in the next three decades to care for many more patients," Dr. Parke said. "The need will be there, and it will have to be addressed by roughly the same number of ophthalmologists. Practices will have to become more efficient, while maintaining their commitment to the quality of care and patient satisfaction."

A demonstration of the practice benchmarking database will be featured in the AAOE's exhibit hall booth. Ophthalmology practices will be able to enter data into the database beginning next April. Practices that contribute data will have free access to the database to explore how their practice is doing in comparison to their colleagues.

GIVING BACK:Making a Difference in Africa
Cathy Schanzer: Mother, Physician and Dedicated Volunteer.
By Leslie Goldberg, Assistant Editor

Cathy Schanzer, M.D., medical director and chief surgeon at Southern Eye Associates in Memphis, Tenn., and mother to seven adopted children, felt the calling for mission work early in her professional career. After a few years in private practice, the frustrations of paperwork requirements and medical bureaucracy helped motivate Dr. Schanzer to act on her wish to provide medical care in its purest, simplest form.

She first traveled to Africa in 1988. With little information at hand, she gathered supplies, got her immunization shots, and at the last minute, her husband, Tom, decided to join her (he thought it would be a good idea that if she was going to face danger, he should be along for the trip). Their work began in Nigeria and later included efforts in Zimbabwe and Mozambique.

Six years ago, at the encouragement of a friend, they trekked to Sierra Leone, a country recovering from a long and brutal civil war. While they loved Sierra Leone, it provided an enormous challenge. Among many obstacles, the entire infrastructure of the country had been destroyed. Refugee camps, orphaned children, lack of water and electricity, pothole-filled roads and minimal housing were the norms. Most of the nation's medical care facilities had also been destroyed.

Dr. Schanzer and Serabu children celebrating the eye clinic opening.

The couple initially volunteered at the Kissy Eye Clinic in the capital city of Freetown. Then, in 2005, they were asked to go to Serabu, 7 bumpy-road hours southeast of Freetown and the home village of Catholic Archbishop Joseph Ganda. The war had virtually destroyed the entire village and Archbishop Ganda had requested that Cathy and Tom help "his people." Dr. Schanzer recalls their arrival at the village. She observed that most people live in makeshift huts and water is carried from a local stream. She was the first doctor there in 15 years and was soon inundated with general medical problems. She also had to deal with tribal chiefs, local healers, the Catholic diocese and a slowly recovering national healthcare system.

Once committed to the mission in Serabu, Cathy and Tom began to transform a simple block building into a modern eye clinic and surgical facility, adding diagnostic and surgical equipment, well-water gravity-flow plumbing, generator electricity and an air conditioner to climate-control the operating theatre. They hired seven full-time local employees, including three trained technicians from Freetown, who Dr. Schanzer says have a wealth of medical knowledge. These people agreed to leave their own families to go to Serabu because they felt so strongly about the mission. The clinic has a full-time ophthalmic nurse, optician and
operating theater technician but does not yet have sufficient physician/surgeon coverage.

Cathy and Tom travel there twice a year for 3 weeks at a time, with Dr. Schanzer performing nearly non-stop surgery each trip. Tom assists with patient care logistics and behind-the-scenes support for all the operating systems that keep the clinic open. Area residents plan for their arrival and begin walking 3 to 4 days in advance of their coming. Dr. Schanzer has taught the clinic employees how to do A-scans and keratometry so they can correctly perform IOL calculations and lens selection. "I am amazed at what has been accomplished," says Dr. Schanzer. "It is both very humbling and very rewarding. While we began this venture with the idea of giving, we have received much in return. We have witnessed the true meaning of life and living under very harsh conditions."

Cathy and Tom have also established Southern Eye Institute as a 501(c)(3) organization to support their mission efforts. Private funds and outside donations support the clinic operations. They are recruiting visiting surgeons and will help coordinate all travel logistics. Interested physicians can contact them through their Web site at www.southerneyememphis.com or by calling Tom Lewis directly at (901) 569-3939.

Sirion: A New Player in Ophthalmic Market
The Company Already Has Three Drug Candidates.
By Jerry Helzner, Senior Editor

Though Sirion Therapeutics is a new company, formed late last year with the goal of developing ophthalmic products that meet unmet needs in the eyecare market, the company already has an experienced management team that would be the envy of many mature companies.

Sirion, based in Tampa, Fla., has taken its name from the star Sirius, the brightest star in the sky. The company also hopes to shine brightly, with an ambitious development program that calls for the launch of four new drugs in 2008.

"We are excited about the potential that this product brings to Sirion," said Roger Vogel, M.D., Sirion's chief medical officer. "We believe that this strong steroid can fill a gap in the current treatment options for moderate and severe inflammatory diseases of the eye."

Adds Glenn Jaffe, M.D., professor of Ophthalmology and director of the Uveitis Service at Duke University: "Difluprednate ophthalmic emulsion would become the first high-potency steroid launched in ophthalmology in over a decade. This has the potential to be a significant addition to our treatment options for serious inflammatory eye diseases that cause blindness."

Sirion Chairman and CEO Barry Butler said the company expects to file an Investigational New Drug application for difluprednate ophthalmic emulsion with the FDA by the end of this year and plans to begin phase 3 trials in the U.S. during the first half of 2007.

In July, Sirion announced a second licensing agreement when it acquired exclusive U.S. rights from Laboratorios Sophia of Mexico for a topical solution with the active ingredient cyclosporine A for ophthalmic use. The company plans to initiate clinical trials for this compound, which Sirion has designated ST-603, in the first half of 2007.

"We think the unique properties of the ST-603 formulation can position it to gain significant market share in the U.S. cyclosporine market," said Butler.

More recently, Sirion has acquired Sytera Inc., a La Jolla, Calif., company that is developing a potential treatment for the dry form of AMD and Stargardt's disease. Through the merger with Sytera, Sirion obtains the compound ST-602, formerly designated SYT101 (Fenretinide). ST-602 is an oral compound aimed at reducing the accumulation of lipofuscin in the eye by lowering the body's level of serum retinol (vitamin A). It is hypothesized that the accumulation of lipofuscin in the eye is responsible for vision loss in diseases such as dry AMD, geographic atrophy and Stargardt's disease. The company is initiating a proof of concept trial later in 2006.

The Sirion management team is led by Butler, who brings 18 years of experience in the pharmaceutical industry, including holding a variety of management and senior management positions at companies such as Bausch & Lomb and Glaxo. Dr. Vogel, the chief medical officer, spent 16 years with Merck, where he rose to the position of global head of clinical research for ophthalmology and infectious diseases.

Initial financial support for Sirion has been provided by NovaQuest, the strategic partnering group of Quintiles Transnational Corp., and Avalon Ventures, a venture capital company. In late September, Sirion announced that it has secured an additional $25 million in financing from a group of institutional investors. The new funding will be used to develop and commercialize Sirion's product portfolio. Toward this end, Sirion has added additional personnel experienced in bringing ophthalmic products to market.

IN THE NEWS

■ Improved-design Tecnis launched. Advanced Medical Optics, Inc. (AMO) has introduced the Tecnis CL IOL with design enhancements. Improvements include blue modified C PMMA haptics for better visibility and easier implantation of the lens, frosted OptiEdge design for reduced edge glare and reduced posterior capsule opacification and patented silicone material for long-term biocompatibility performance.

The Tecnis CL IOL can be implanted with the Unfolder Silver Series Implantation Systems and the Silver Advanced Cartridge through a 2.8 mm incision. It permanently replaces both the Z9000 and Z9001 Tecnis silicone IOL models.

"The Tecnis CL IOL provides the same FDA-approved claims and excellent outcomes as the original Tecnis lens but with a more user-friendly design," said Russ Trenary, AMO corporate vice president and chief marketing officer. "We expect the Tecnis CL lens to speed surgeon migration from older-generation silicone lenses to the superior Tecnis optical design.

CMS extended New Technology Intraocular Lens (NTIOL) status to the Tecnis CL lens in August. The Tecnis and Tecnis CL lenses are the only FDA-approved IOLs with claims for reduced spherical aberration, improved functional vision and improved night driving simulator performance.

■ SOLX acquired. OccuLogix, Inc., which is developing a rheopheresis treatment for the dry form of AMD, has completed its acquisition of SOLX, Inc., the developer of an innovative new treatment for glaucoma. Based at the Boston University Photonics Center, SOLX has developed the DeepLight Glaucoma Treatment System, a next-generation treatment platform for reducing IOP. The DeepLight System includes the DeepLight 790 Titanium Sapphire Laser and the DeepLight Gold Micro-Shunt, which can be used separately or together to provide patients with multiple options for IOP reduction. The DeepLight 790 and the DeepLight GMS have received international CE approval are currently the subjects of two randomized, multi-center studies being conducted in the United States.

Doug Adams, SOLX president and CEO, has joined OccuLogix as president of the new subsidiary.

■ Shuler joins AMO/VISX. AMO/VISX has recently hired Michael Shuler as laser vision correction director of global strategic accounts, primarily working with VISX technology. He will be assisting management with key accounts, both in the United States and internationally.

Shuler joins AMO with 35 years of experience in ophthalmic business and sales. He previously worked in sales management with such companies as Syntex Ophthalmics, Cooper Vision, Storz Ophthalmics and also with VISX previously as director of sales from 1995 to 2002. Before rejoining the AMO family, he was vice president of business development and helped launch sales for WaveLight Inc.