at press time

Charles Kelman: Ophthalmology Giant
Inventor of Phaco Successfully Fought the Establishment.

"Charlie Kelman was ophthalmology's equivalent of Babe Ruth."

So says Robert Sinskey, M.D., clinical professor of ophthalmology at the Jules Stein Eye Institute at UCLA and a longtime friend and colleague of Charles Kelman, M.D., who died of lung cancer on June 1 at the age of 74. Dr. Kelman was a pioneer in cryosurgery and he revolutionized cataract surgery with his invention of phacoemulsification in the late 1960s. He got the idea for phaco while having his teeth cleaned with an ultrasonic device.

	Dr. Charles Kelman

Like Babe Ruth, Dr. Kelman had prodigious skills, accumulating more than 100 patents in his lifetime. He also had a larger-than-life presence that made him many friends but also caused him to be a controversial figure early in his medical career.

"The fact that he played the saxophone and did stand-up comedy, didn't endear him to the ophthalmology establishment," recalls Dr. Sinskey. "From the beginning, the establishment was skeptical about the value of phacoemulsification. When Charlie couldn't get his papers published in the peer-reviewed journals, he went to the lay press to get his ideas out."

"Probably no one who's made a major contribution to medicine took more abuse than Charlie Kelman," asserts I. Howard Fine, M.D., clinical professor of ophthalmology at the Casey Eye Institute, Oregon Health and Sciences University, and a renowned cataract surgeon in his own right. "What drove the eventual acceptance of phaco was the realization by individual eye surgeons across the country and around the world that the outcomes could be so much better than with any other procedure for extracting cataracts."

Dr. Fine first met Dr. Kelman at an American Society of Cataract and Refractive Surgery meeting in Los Angeles in the early 1980s.

"What impressed me the most about him was that he was so friendly and approachable. He truly became my role model. He was able to successfully combine patient care, teaching and research, while also being accessible and encouraging us to be innovative."

Charles Kelman was born in Brooklyn, N.Y. in 1930. His original goal was to become a bandleader but his father insisted that he first become a physician. Kelman graduated from Tufts University in 1950 and completed his medical studies in Geneva, Switzerland, in 1956. He then completed an internship at Kings County Hospital in Brooklyn and a residency in ophthalmology at Wills Eye Hospital in Philadelphia.

Once phaco achieved acceptance, Dr. Kelman received numerous honors. His wealth enabled him to indulge his hobbies, including flying his own helicopter and renting out Carnegie Hall for a night to put on his own show.

Dr. Kelman, who had homes in Boca Raton, Fla., and on Long Island, is survived by his wife, Ann, two daughters and three sons.

For more personal reminiscences about Dr. Kelman, please turn to page 36.

ASOA Founder Lucy Santiago to Retire
Her Efforts Made Ophthalmic Administration a Profession.

Lucy Santiago, who founded the American Society of Ophthalmic Administrators (ASOA) after presenting a landmark practice management course at the 1986 American Society of Cataract and Refractive Surgery (ASCRS) meeting, plans to retire as executive director of the organization.

"Letting go is hard, but I believe change is necessary," said Santiago.

Lucy Santiago

As the administrator of an ophthalmology practice in Dallas in the 1980s, Santiago was frustrated because there was no professional organization she could turn to for support, or even to answer a question. She took matters into her own hands in 1986 by devising a 6-hour course that included instruction in patient management, office efficiencies, finance and marketing. The course, which she called "The 24-Hour Administrator," proved highly popular. With the help of ASCRS, the ASOA was soon created.

"We had 300 members almost immediately," says Santiago. "ASOA has made ophthalmic practice administration a true profession. We publish and update the Ophthalmic Regulatory Manual, which covers such key areas as Medicare law, compliance, reimbursement and HIPAA rules. We've also created the Certified Ophthalmic Executive (COE) credential, which enables people to qualify as professional ophthalmic administrators."

"Lucy Santiago has become something of an ophthalmic institution in her own right with her founding of ASOA and being the driving force of many of its innovative programs," said ASOA President Steve Robinson, COE.

ASCRS President Priscilla P. Arnold, M.D., added: "Lucy has been uniquely dedicated to the development and success of ASOA. She has offered support, advice and encouragement to many of our members. She will be greatly missed."

ASOA's mission is to develop and advance the skills of ophthalmic practice administrators by providing training programs, identifying new products and services, and seeking avenues for administrators' personal and professional growth. The organization now has about 2,000 members. For information, log on to www.asoa.org.

IRS to Step Up Retirement Plan Audits
Make Sure Your Plan is in Compliance.

Ophthalmology practices now have even more reasons to make sure their retirement plans are up to date and properly operated.

Mark Kropiewnicki, J.D., LL.M., a principal consultant with the Health Care Group in Plymouth Meeting, Pa., cautions that the IRS will significantly increase the number of retirement plan audits this year. This increase is largely the result of the IRS' ability to now redeploy resources to the audit function through its recent formation of dedicated retirement plans determination letter and audit groups.

Kropiewnicki says the IRS has instructed its field agents generally to conduct retirement plan audits at a taxpayer's place of business. The IRS is willing to be flexible in working to schedule audits at a time least disruptive to a taxpayer's business.

Although IRS regulations permit you to request that an audit take place in a location other than your place of business (such as at your attorney's office) the IRS has a declared preference for conducting on-site audits. The IRS believes on-site audits are more efficient because its agents have ready access to source documents such as personnel files and payroll records, including access to any additional records the IRS needs or wants.

"The IRS also believes that such on-site audits present IRS agents an opportunity to familiarize themselves with your daily operations," notes Kropiewnicki.

Now, more than ever, make sure your practice's retirement plans are completely current and operated in accordance with the retirement plan's provisions, concludes Kropiewnicki, who can be reached at (800) 473-0032, or via e-mail at mark@healthcaregroup.com.

IN THE NEWS

Panel schedules Macugen. An FDA advisory panel will review Eyetech's New Drug Application for its investigational wet AMD treatment Macugen on Aug. 27. Eyetech stock jumped 14% on the day this news was announced.

Retaane AMD trials. Alcon said data from a Phase II/III clinical trial of its anecortave acetate for depot suspension (Retaane 15 mg) treatment for wet AMD shows that 73% of patients treated with Retaane 15 mg demonstrated stable or improved vision after 2 years. In addition, 94% of patients who received Retaane experienced no severe vision loss after 2 years.

Alcon said it plans on filing a New Drug Application (NDA) for Retaane with the FDA in the fourth quarter of 2004. If the NDA is approved, the company plans to launch the drug in the first half of next year.

In a related development, Jason Slakter, M.D., of the Manhattan Eye, Ear and Throat Hospital, has initiated a study using a combination of Retaane and triamcinolone acetate to treat the subfoveal occult and subfoveal minimally classic forms of wet AMD.

"Given the nature of these two drugs, it is possible that a combination of the agents may provide a synergistic effect, with the strong anti-permeability effect of the steroid combined with the antiangiogenic effect of the anecortave acetate," said Dr. Slakter.

ISTA drug approved. The FDA has approved ISTA Pharmaceuticals' New Drug Application for Istalol, a once-a-day liquid formulation of the beta-blocking agent timolol for the treatment of glaucoma. The company says other formulations of timolol currently on the market are commonly prescribed as twice-daily solutions or gel formulations.

"Istalol gives patients and their caregivers an effective therapeutic option with the convenience of once-daily formulation," said Thomas K. Mundorf, M.D., a clinical investigator for the U.S. Istalol clinical studies.

"We anticipate launching Istalol within the next few months, after we have secured sufficient commercial quantities from our manufacturer," said Vicente Anido, Jr., Ph.D., president and CEO of ISTA.

ISTA acquired the exclusive U.S marketing rights to Istalol from Senju Pharmaceutical of Japan, which originally developed the product for the Japanese market.

B&L generic approved. The FDA has approved Bausch & Lomb's Abbreviated New Drug Application to manufacture and market ciprofloxacin ophthalmic solution USP, 0.3%, an anti-infective indicated for treating bacterial eye infections, including conjunctivitis and corneal ulcers. This generic form of the branded medication Ciloxan is immediately available in three sizes: 2.5 mL, 5 mL and 10 mL

Lumigan in Japan. Allergan has signed an exclusive licensing agreement that will allow Senju Pharmaceuticals to market its glaucoma medication Lumigan in Japan. Senju will be responsible for product development and commercialization in the Japanese market and incur associated costs. Senju will also make an initial payment to Allergan, plus milestone payments and royalties based on Lumigan sales.

REFRACTIVE SURGERY UPDATE

IntraLase slates IPO. IntraLase Corp., which develops and markets femtosecond lasers used to cut flaps for LASIK procedures, has announced it will sell approximately $92 million in company stock to the public in an initial public offering. When the shares are issued, they'll trade on the NASDAQ National Market under the symbol "ILSE."

Underwriters for the offering are Bank of America Securities, Wachovia Securities, First Albany Capital and ThinkEquity Partners.

Veriflex phakic IOL. Advanced Medical Optics and Ophtec USA say they will expand their relationship in order to commercialize a foldable version of their Verisyse phakic IOL and an accompanying insertion device. A foldable version, called the Veriflex, is currently in clinical trials in Europe. The Verisyse is currently pending FDA approval after being recommended for approval by the FDA Ophthalmic Devices Panel.

Nidek hyperopia study. Nidek has announced favorable 3-month clinical data for its hyperopia study of 46 eyes using the EC-5000 excimer laser platform. The company has received FDA approval to expand the study to 300 eyes, including 150 eyes for spherical hyperopia and 150 eyes for hyperopic astigmatism.

At 3 months, 97.8% of treated patients demonstrated UCVA of 20/40 or better.

VISX profit doubles. VISX Inc., a leading maker of laser vision correction equipment, said earnings for the first quarter of 2004 amounted to 23 cents a share compared with 11 cents in the same period a year ago. The gain came on a 20% increase in procedure volume.