at press time
STAAR's Phakic IOL is Approved
The Visian is Indicated for Moderate-to-Severe Myopia.

STAAR Surgical ended 2005 on a high note with the long-awaited FDA approval of the company's Visian Implantable Collamer Lens (ICL) for the treatment of moderate-to-severe myopia. Approval came much later than initially expected, as the company had to bring its California manufacturing facility in compliance with FDA standards.

The delay cost the Visian "first mover" advantage in the U.S. phakic IOL marketplace, as Advanced Medical Optics (AMO) won approval for its Verisyse phakic lens in September of 2004. However, the Visian differs greatly from the Verisyse in that it is a foldable posterior chamber lens, while the Verisyse is an iris-clip PMMA lens.

The Visian ICL is indicated for the correction of myopia in adults ranging from -3.0 D to less than or equal to -20.0 D, with astigmatism less than or equal to 2.5 D at the spectacle plane, in patients 21 to 45 years of age with anterior chamber depth 3 mm or greater, and a stable refractive history within 0.5 D for a year prior to lens implantation.

The Visian ICL is made of STAAR's proprietary, highly biocompatible collamer material. The company says it is the only minimally invasive foldable lens of its kind approved for the U.S. commercial market. As a result of the unique foldable design, STAAR says the ICL procedure allows an incision up to 50% smaller than competing technology, and its placement in the eye behind the iris provides a more aesthetically pleasing outcome. In addition to the United States, the ICL is also approved for sale in 41 countries, including those in the European Union. It has been implanted in more than 40,000 eyes worldwide.

STAAR expects to begin shipping the Visian ICL to trained doctors sometime in February.

"Receipt of FDA approval represents a critical milestone," said David Bailey, president and CEO of STAAR Surgical. "Throughout the approval process, doctors' interest in our state-of-the-art lens has continued to build, driven by superior clinical outcomes, the stability and safety of the procedure, and the high patient satisfaction rate.

"We continue to plan for a controlled commercial launch and believe that the investments we made in our marketing programs 2 years ago have allowed us to build the infrastructure necessary to be successful," continued Bailey. "As we have done internationally, we will guide doctors through our training and certification process, which includes proctoring the first five surgeries.

"Currently, we have more than 860 surgeons who have completed the first phase of training and are ready to be proctored by the five application specialists that we have on staff. Once the doctors have successfully completed the surgeries, they will become certified and will be eligible to order additional Visian ICL lenses without a proctor. We believe that this process, which focuses on correct technique, will support high quality clinical outcomes and better ensure proper use of the lens."

GIVING BACK: Bringing Eye Care to the Third World
Dr. Geoff Tabin Builds on the Himalayan Cataract Project.
By Jerry Helzner, Senior Editor

Dr. Tabin examines a young patient in the Himalayan country of Bhutan.

With this issue, Ophthalmology Management inaugurates 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.

The Himalayan Cataract Project, which has restored the sight of tens of thousands of residents of Nepal, Sikkim, Bhutan and Tibet in the last 12 years, will now serve as a model for an international effort to provide professional eye care to additional third-world countries.

This expanded effort has been made possible by the recent move of Geoff Tabin, M.D., the founder of the Himalayan Cataract Project (HCP), to the John A. Moran Eye Center of the University of Utah. Dr. Tabin, who has successfully blended his love of mountain climbing with a desire to bring professional eye care to the countries that make up "the roof of the world," has now been given the time and resources to export the HCP model to Africa and other parts of the globe where better eye care is needed. He now serves as professor of ophthalmology and director of the division of international ophthalmology at the Moran Eye Center.

"This effort is continuing a long tradition of international outreach at the University of Utah," says Dr. Tabin. "My focus will be on expanding and developing international projects. We will be bringing in many international fellows, improving subspecialty training, and expanding already existing relationships with hospitals in Kumasi, Ghana; Nairobi, Kenya; and in Indonesia and the South Pacific. Our ongoing programs in Africa are the result of years of work by several Moran ophthalmologists, including Dr. Alan Crandall, Dr. Bob Hoffman and our chairman, Dr. Randall Olson."

A Life of Achievement

A female cataract patient expresses gratitude for the care she receives.

If any ophthalmologist has the experience and dedication to lead a major international effort, it is probably Dr. Tabin.

Dr. Tabin, 48, a graduate of Yale University and the Harvard Medical School, also spent 2 years at Oxford in England as a Marshall Scholar. He is one of a few people in the world to have climbed the highest peak on every continent. His 1993 book, Blind Corners, which recounts his many early adventures, including his role as one of the world's first bungee jumpers, has been widely praised. 

Dr. Tabin was on his way to a career as an orthopedic surgeon when he dropped out of a residency program to serve as team doctor for a climbing expedition scaling Mount Everest. While filling-in as a primary care doctor in Nepal, Dr. Tabin watched visiting Dutch doctors perform surgery on people who had been blinded by large, advanced cataracts. (A combination of reflected UV sunlight, genetic and dietary factors likely contribute to the incidence of cataracts in Himalayan countries being among the highest in the world.)

"I saw these miracles being performed and I started to think that as an ophthalmologist I could really make a difference in these people's lives," says Dr. Tabin. He then returned to the United States to enter an ophthalmology residency program at Brown University.

On one of his trips to Nepal, Dr. Tabin teamed up with a Nepali ophthalmologist, Sanduk Ruit, M.D. In 1994, the two doctors initiated the Himalayan Cataract Project, which has sustained itself over the years with grants and donations while training more than 50 eye doctors from the Himalayan region. The HCP now has a permanent, fully equipped clinic called the Tilganga Eye Center in Kathmandu, the capital of Nepal.

As part of his extensive efforts, Dr. Tabin has volunteered in China.

The HCP Technique

The HCP also operates remote eyecare camps where a cost-effective sutureless manual extracapsular technique is used on thousands of cataract patients each year at no cost to the patient.

"We can do these surgeries quickly and efficiently at a cost to us of about $20 a patient," says Dr. Tabin. "We had Dr. David Chang of the University of California, San Francisco, here doing phaco in the clinic and we found that the outcomes for our small-incision extracapsular technique and for phaco were comparable for the advanced cataracts in Nepal, except that our manual technique is much faster and less expensive."

A number of the local ophthalmologists have now received subspecialty training in Australia, Europe and the United States, allowing the Tilganga Eye Center to provide a wider range of services.

"We are now doing corneal transplants, corneal surgery and keratoplasty," notes Dr. Tabin. "Our local doctors are currently being trained in a variety of subspecialties, including retina, pediatric, oculoplastics and uveitis."

In addition to Drs. Tabin and Ruit, Marc Leiberman, M.D., and Prof. Hugh Taylor of the ophthalmology department of Melbourne University, Australia, have also played a major role in the success of the HCP.

Dr. Tabin stands at the summit of Mount Everest in Nepal.

Drs. Tabin and Ruit have written a new book, Fighting Global Blindness, about their approach to providing cataract surgery to those who sorely need it in the Himalayas and other developing countries.

Dr. Tabin says his love of mountain climbing, rock climbing and skiing was instilled in him at an early age by his father, a physicist.

"My dad worked on the Manhattan Project in Los Alamos, New Mexico, during World War II," says Tabin. "He got into hiking and skiing, so I had a father who encouraged my interest in those areas. I developed a passion for climbing because it has its meditative aspects, along with an incredible need for focus and the ability to be a reliable partner."

As Dr. Tabin works to expand the HCP model into a global effort, those qualities of thoughtfulness, perseverance and character should stand him in good stead.

Donations to the Himalayan Cataract Project can be made through the organization's Web site at www.cureblindness.org, or by contacting Dr. Tabin at Geoffrey.Tabin@hsc.utah.edu.

Office Space: To Buy or Not to Buy?
Each Option Has its Pros and Cons.
By Leslie Goldberg, Assistant Editor

"In ophthalmology, you don't need to have the most expensive real estate to have a successful practice," says Michael Mann, M.D., of Mann Eye Institute and Laser Center in Houston and Austin, Texas. "If you have built a good reputation and provide good care, patients will follow you.

"Early on in your career, you may not have a lot of capital to put into real estate," continues Dr. Mann, "Additionally, you may not understand the real estate market in the area. In these cases, it is safer to lease. You do not want to make a purchase and wind up outgrowing your space. You need to do your due diligence and know your long-term goals before purchasing."

To help guide your decision-making, the About.com Guide for Small Business Information has assembled some facts on leasing vs. buying office space.

Pros of Buying Office Space

►Fixed Costs: Locking in a commercial mortgage long-term can give your business clear, fixed costs.

►Tax Deductions: The associated costs of owning and operating a commercial space can provide expense deductions in the form of mortgage interest, property taxes and other items.

►Additional Income: Owning your office can offer the advantage of renting out unused office space, thus adding another source of income.

►Retirement Fund: The prospect of owning commercial space and having the property appreciate over time allows the owner to sell out and fund a comfortable retirement.

Cons of Buying Office Space

►Lack of Flexibility: A new or growing business may experience unexpected future needs.

►Upfront Costs: Buying commercial space will initially cost far more upfront. There are property, appraisal and maintenance costs, along with a large down payment and possible property improvement costs.

Pros of Leasing Office Space

►Prime Property: A leasing option provides a business with the chance to rent in an area with a good location and positive image. If a small business is dependent on location and image, such as retail or restaurants, the leasing option is much more affordable.

►Free-up Working Capital: With your money not tied up in real estate, your business can respond to opportunities in the market. In addition, your ability to borrow additional funds will not be as limited.

►More Time: Any type of ownership comes with headaches. A leasing option affords the time to focus solely on running your business.

Cons of Leasing Office Space

►Variable Costs: With a leasing option, you may be subject to annual rent increases and higher costs when your lease expires.

►No Equity: With leasing, you will be funding someone else's retirement with your lease payments. However, owning does require you to get involved in the property management business.

Additional Considerations

"The most important consideration when making a real estate decision is location, location, location," says Rick Alphonso, of The Financial Advisory Group, Inc., in Houston, Texas. "Often, in a bigger city, you may not be able to buy an attractive piece of land or actually build what is desired on a specific piece of land. You may be forced to lease something because there's nothing to buy in that locale."

Chris Kolenda of The Financial Advisory Group, Inc. says, "Many times, purchasing a property is like purchasing a home. You have to ask yourself, do you want to commit to a long-term stay in an area, do you want to own the land, and what's your appetite for risk?"

The answer to whether to lease or buy office space is not clear-cut. It is recommended that you bring in your accountant and financial planner to help guide you in the decision.

IN THE NEWS

►Diquafosol in limbo. Inspire Pharmaceuticals, Inc. said the FDA has issued a second approvable letter for diquafosol tetrasodium ophthalmic solution, an investigational treatment for dry eye.

The FDA approvable letter included the following statement: "The submitted clinical studies fail to demonstrate adequate replication of results for the efficacy endpoints and therefore are insufficient to establish efficacy. Based on our review of the submitted data, consistent findings of corneal clearing need to be demonstrated to support the efficacy of the drug product."

Christy L. Shaffer, Ph.D., president and CEO of Inspire, stated, "In the approvable letter, the FDA strongly encouraged us to meet with them to discuss how best to move forward with the application. We intend to request this meeting in the near future. In addition, our Joint Development Committee with Allergan will be meeting to discuss strategies for the program. We plan to provide an additional update on this program following the FDA meeting and discussions with Allergan."

►Spreading agent approved. Halozyme Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, announced that the FDA has approved Halozyme's Hylenex recombinant hyaluronidase for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs. Baxter Healthcare Corporation will market Hylenex in the United States.

Halozyme has targeted ophthalmic surgery as a key market for Hylenex. The drug will compete with the animal-based hyaluronidase offered by competitors. The company believes its formulation is purer than animal-derived hyaluronidase and will be less likely to cause allergic reactions.

►Reichert buys Tono-Pen. Medtronic has sold its Tono-Pen line of applanation tonometers, along with its Ocu-Film tip covers and Model 30 Classic pneumatonometer product to Reichert. These products accounted for more than $10 million in annual sales.

The remainder of Medtronic's ophthalmic product lines are now being incorporated into the company's ENT division, said Randy Mansfield, vice president and general manager of Medtronic Ophthalmics.

►Lucentis BLA filed. As anticipated, Genentech,Inc. submitted a Biologics License Application (BLA) to the FDA in late December for the use of Lucentis in the treatment of wet AMD. Lucentis is the first therapy for wet AMD to have shown improved vision in two pivotal phase 3 trials and demonstrated a clinical benefit over Visudyne photodynamic therapy in a head-to-head clinical trial. As part of the Lucentis BLA submission, Genentech has requested a Priority Review designation from the FDA, which, if granted, would give the FDA 6 months from the agency's receipt of the submission to take action on the application.

The BLA submission is based on 1-year clinical data on the efficacy and safety of Lucentis from two pivotal phase 3 trials, ANCHOR and MARINA, as well as 1-year clinical data from the phase 1/2 FOCUS trial. In addition to these registrational studies, Genentech is currently enrolling patients with wet AMD in a phase 3b safety study called SAILOR.

Data from the phase 3b PIER study evaluating a less frequent dosing regimen for Lucentis are anticipated in the first half of 2006.

"This application represents a summary of data from more than 6 years of rigorous clinical study and the dedication of thousands of patients and physicians hoping to improve outcomes for those with this devastating disease," said Hal Barron, M.D., Genentech's senior vice president of Development and chief medical officer.

WORTH NOTING

►Eyemaginations' new CEO. Eyemaginations, Inc. a leading 3-D animation and multimedia marketing and education company serving the eyecare industry, said Jeffrey Peres has been appointed president and CEO. The company's founder, Steven F. Sopher, O.D., will remain chairman of the board.

"Jeffrey has taken our business to a new level. His ability to build, manage and nurture multiple relationships has been enormously helpful to our business," said Dr. Sopher. Dr. Sopher will continue to be closely involved with developing new animations, networking with fellow doctors and providing tours of his showcase optometric practice in Towson, Md.

Peres, 36, joined Eyemaginations early last year and was serving as the company's chief operating officer. Prior to joining Eyemaginations, Peres was an investment banker. He earned his M.B.A. from the Wharton School at the University of Pennsylvania and his B.A. from Cornell University.

►Eyeonics completes financing. Eyeonics, inc., the developer and manufacturer of the crystalens, the only FDA-approved accommodating IOL, said it has successfully completed its Series E round of financing for $16.2 million. The round was led by Versant Ventures, a new investor. All of eyeonics' previous investors, Brentwood Associates, Pequot Private Equity, ABS Ventures and Entrepreneurs Fund, participated in the financing.

"We are pleased to have a high quality institution like Versant Ventures join our existing investor base," said J. Andy Corley, chairman and CEO of eyeonics. "This funding will be primarily used to support the expansion of our distribution capabilities for the crystalens. Investment in our distribution should allow us to increase our field presence to approximately 100 employees during 2006."