Ever since childhood, Richard C. Rashid, M.D., has suffered from a severe case of dry eye. Now, he would like other opthalmologists to consider recommending a therapeutic strategy called "saturation-dosing" that has brought relief to him, his four children and scores of his patients with dry eye.

Dr. Rashid, pictured at right, also uses saturation-dosing for patients who have just undergone laser vision correction surgery -- to reduce or eliminate any post-surgical symptoms of dry eye. And he advocates super-dosing prior to laser vision correction surgery, particularly for patients who have a history of dry eye.

The doctor's recommendation is largely based on personal experience.

"I had trouble opening my eyes in the morning. It was very painful," says Dr. Rashid, who has had an ophthalmology practice at the Eye Physicians & Surgeons Corporation in South Charleston, W. Va., for the past 32 years.

For years, Dr. Rashid used artificial tears up to 20 times a day.

"Sixteen years ago, I had all my tear drains closed with laser treatments," says the doctor.

But over the past few years, Dr. Rashid has successfully used saturation-dosing for himself and his patients. He credits Jeffrey Gilbard, M.D., of the Harvard Medical School for developing the therapy.

"I believe anyone with dry eye can benefit from saturation-dosing," says Dr. Rashid.

Here's how it's done:

�        Three or four times a day (particularly before going to bed and upon awakening), patients should instill one or two drops of artificial tears in each eye. It's important that the tears have no preservative, or only sodium perborate, a very mild preservative.

�        Patients should then close their eyes for one minute.

�        Patients should then repeat this procedure four more times to ensure that the tissue is hydrated.

Dr. Rashid notes that Dr. Gilbard's research has shown that after several weeks of saturation-dosing, the conjunctival goblet cells begin to rejuvenate themselves, making the corneal surface more easily wettable.

"I believe in saturation-dosing because I know how much it's helped me and my patients," concludes Dr. Rashid.

STOCK WATCH
A LOOK AT THE PERFORMANCE OF OPHTHALMIC COMPANIES as of 9/11/00

One Claims Form For All
Government Streamlines Electronic Filing.

It's going to get a lot simpler to file electronic claims for healthcare services.

The Department of Health and Human Services (HHS) has issued a final ruling designating standard electronic formats that can be used by all healthcare providers and that must be accepted by all healthcare plans. Providers will still be able to use paper forms, but the simplified process will encourage more electronic filing.

The standard formats, required by the Health Insurance Portability and Accountability Act (HIPAA), will be published in the Federal Register. They cover claims submission and other administrative health transactions. Providers can also use the standard formats to determine eligibility for insurance coverage, ask the status of a claim, request authorizations for services or specialist referrals, and receive electronic remittance to post receivables.

HHS Secretary Donna Shalala hailed the new standards, saying they represent an important step toward a faster, simpler, less costly and more efficient healthcare system. Shalala said the next step in streamlining the system will come late this year when HHS establishes national identification numbers for providers to speed claims processing. In addition, HHS will announce steps to make electronic health data secure and protect patient privacy.

Most insurers and providers have 26 months to comply with the government regulation by implementing the new formats. Some small insurers will have an additional year to make the transition.

New "Pink Eye" Treatment Receives FDA Approval
Santen's Quixin Faces Patent Litigation.

The FDA has granted approval to Santen Incorporated, the U.S. subsidiary of Santen Pharmaceutical Co., Ltd., to market its new ocular anti-infective medication, levofloxacin ophthalmic solution 0.5% (Quixin). The drug, in eye drop form, has proven effective in the treatment of bacterial conjunctivitis, more commonly known as "pink eye."

Quixin is expected to be launched in the U.S. market this year. One obstacle: In late August, Allergan filed a lawsuit against Santen Inc., claiming that Quixin infringes on Allergan's license of Daiichi Pharmaceutical Company's patented compound ofloxacin. Santen is contesting the lawsuit and says it will proceed with the launch.

The new drug is a sterile, topical ophthalmic solution containing 0.5% levofloxacin, a potent, broad spectrum fluoroquinolone. Levofloxacin's higher solubility, at neutral pH, allows Quixin to be formulated at a higher concentration of active drug compared to other currently marketed ophthalmic fluoroquinolones (0.5% vs. 0.3%), says Santen.

In controlled clinical trials in which bacterial conjunctivitis patients were dosed with Quixin for 5 days, 79% of the patients experienced clinical cure, while microbial eradication rates were 90%, Santen says. The company notes that the drug has demonstrated efficacy against a wide range of causative organisms, including the most common gram-positive and gram-negative pathogens.

"Quixin is the second of several innovative Santen products scheduled for introduction to the U.S. and European markets. Pemirolast potassium ophthalmic solution 0.1% (Alamast) was launched recently for the treatment of itching associated with allergic conjunctivitis," says Jerry Hansen, president and CEO of Santen Incorporated. "Quixin will provide physicians and patients with a powerful new option for treating common eye infections."

Santen Pharmaceutical Co., Ltd., based in Osaka, Japan, specializes in prescription and over-the-counter medications for eye and rheumatic diseases.

Fugo Blade Approved for Capsulotomies
New Device Uses Plasma Technology.

For Richard Fugo, M.D., Ph.D, M.S., and Medisurg Research and Management Corporation, plasma technology has been the key to creating a new device for performing anterior capsulotomies -- using an electronically charged filament that is about the width of a human hair.

Medisurg says the handheld, solid state unit, called the Fugo Blade, creates an anterior capsulotomy without the need for a viscoelastic or a red reflex, allowing the surgeon to dictate surgical conditions rather than react to them.

The Fugo Blade was recently approved by the FDA for use in cataract surgery. (The development of the Fugo Blade by Dr. Fugo and his associates was first reported in the February 1999 issue of Ophthalmology Management.)

According to Medisurg, the Fugo Blade allows quicker, more accurate and safer capsulotomies than capsulorhexis by creating a tiny, completely controllable "cloud" of plasma particles that actually performs the incision. The company says the Fugo Blade is capable of enlarging the capsulotomy size in seconds, enables the surgeon to repair inadvertent tears in the capsule, and has a "Smart Blade" feature that uses an electronic echo to identify and avoid tissue the surgeon doesn't want to incise.

"This is the technologic breakthrough that surgeons will need to compete in the arena of ever-decreasing reimbursement," says Dr. Fugo. "It allows surgeons to do things that are just not possible with present technology."

Visudyne May Play Wider Role
Application Seeks Expanded Usage.

With verteporfin for injection (Visudyne) already approved as a treatment for wet age-related macular degeneration (AMD), CIBA Vision and QLT Inc. have filed a supplemental new drug application with the FDA to expand the indication for Visudyne to other ocular conditions characterized by choroidal neovascularization (CNV). These include pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, CNV caused by specific retinal abnormalities and idiopathic causes.

As you know, CNV is a growth of abnormal blood vessels under the central part of the retina, or macula. These vessels leak fluid and cause scar tissue that destroys central vision.

The supplemental filing is based primarily on new safety and efficacy findings. In one study involving 120 patients with pathologic myopia, 86.4% of those receiving Visudyne therapy showed measurable benefit after 12 months. In another clinical trial, mean visual acuity scores for 26 individuals with ocular histoplasmosis syndrome increased by 6.8 letters on a standard eye chart after 9 months of treatment.

The new application specifically requests an expanded label for the treatment of patients with predominantly classic subfoveal CNV caused by AMD, or with subfoveal AMD secondary to other macular diseases.

The companies have received priority review status from the FDA, which means a decision will come within 6 months.

Survey: Patients Want M.D.s for Laser Eye Surgery
Wisconsin Poll Is Overwhelming.

A recent survey of 400 Wisconsin residents, sponsored in part by the American Academy of Ophthalmology (AAO), found that more than 90% of those polled consider it essential that a person performing laser eye surgery be a trained medical doctor.

The findings support the AAO's position that only ophthalmologists should perform eye surgery.

The issue of who should perform laser eye surgery is particularly timely in Wisconsin, where the state Optometry Examining Board earlier this year had authorized optometrists to perform laser ophthalmic surgery. That authorization has since been rescinded, but the issue remains alive and is likely to go to the Wisconsin state legislature.

The Wisconsin survey, co-sponsored by the Wisconsin Academy of Ophthalmology, also found that 87% of poll participants want the state legislature to vote against any bill granting laser surgery privileges to optometrists.

"While nearly all the people surveyed want only medically trained doctors to perform laser eye surgery, they are not always sure who has that level of training," says Ken Tuck, M.D., AAO president. "For example, 52% of respondents incorrectly stated that optometrists are graduates from an accredited medical school, and 15% believe optometrists are licensed to perform surgery. With so much attention right now on laser eye surgery, including LASIK, the public needs to know who's qualified to perform such surgery and who isn't."

Canada Debates Effects of LASIK on Night Vision
Caution by Canadian Medical Association Stirs Tempest.

About every 10 years, the Canadian Medical Association issues a guide to its member physicians on deternining an individual's medical fitness to drive.

When the new guide came out this year, it made reference to possible detrimental effects of LASIK on the ability to drive safely at night.

The Montreal Gazette jumped on the story, citing data that showed a relationship between LASIK and impaired night vision. Several ophthalmologists who perform laser eye surgery rebutted the article, noting that the data came from patients treated 3 to 8 years ago with older lasers.

The publicity generated a deluge of calls to the Canadian Ophthalmological Society from concerned individuals and may have resulted in some Canadians canceling their plans for LASIK.

HCFA Says Yes
AMD Laser Procedures Can Be Submitted for Medicare Reimbursement.

In a September memorandum, the Health Care Financing Administration (HCFA) said it would allow Medicare claims to be submitted for three types of age-related macular degeneration (AMD) procedures, one of which requires the use of an infrared laser.

However, because local carriers will be allowed to determine the terms of coverage and payment, there is no guarantee these claims will be reimbursed. Previously, the carriers had been instructed by HCFA to classify such claims as "experimental" and deny them.

One reimbursement consultant called the new ruling "a baby step."

Transpupillary thermotherapy (TTT), destruction of macular drusen by photocoagulation, and feeder vessel technique photocoagulation can now be submitted for reimbursement under CPT code 67299. The TTT procedure, which is generally performed using an infrared laser, is primarily for the treatment of early occult neovascularization in AMD. Infrared or standard lasers may be used in the other procedures.

"I suspect some physicians will be reimbursed by the Medicare carrier in their region, but at least initially there will be uneven rulings across the country," says Trexler M. Topping, M.D., a member of the Federal Health Policy Committee of the American Academy of Ophthalmology. "National coverage could be applied by HCFA when and if data from studies currently under way clearly demonstrate the safety and effectiveness of these treatment modalities."

IN THE NEWS

Shocker. Bausch & Lomb stunned Wall Street by saying its earnings would fall well short of analysts' expectations in 2000 and 2001. The company also eliminated the position of president and chief operating officer, and dismissed Carl Sassano, the veteran company executive who held those positions. Bausch & Lomb stock dropped sharply on the news.

In trials. Ista Pharmaceuticals, which develops new remedies for eye diseases, is currently conducting Phase III clinical trials for Vitrase, an FDA-designated fast-track drug for vitreous hemorrhage, and Phase II trials for Keratase, a treatment for corneal opacification. Ista, which also is developing a treatment for keratoconus, recently became a publicly owned company, trading on the NASDAQ National Market.

New alliance. Angiotech is teaming with Alcon Laboratories Inc. to extend the use of Angiotech's paclitaxel surgical implant technology to ophthalmic surgery. The companies believe that paclitaxel implant technology, already used to manage restenosis following vascular surgery, can inhibit scar tissue growth in patients who undergo glaucoma filtration surgery.

Higher reimbursement. A recent HCFA ruling allows hospitals to receive additional "pass-through" Medicare and Medicaid reimbursement for outpatient cataract surgery when a higher-priced, new technology intraocular lens (NTIOL) is used in the procedure. This ruling enables hospitals to utilize the most advanced technology without incurring a financial penalty. A different reimbursement plan for ambulatory surgical centers using NTIOLs had been previously authorized. John S. Jarstad, M.D., an ophthalmologist in Federal Way, Wash., says the net result will be to make NTIOLs more accessible to more patients.

Vision care contract. Davis Vision, which already provides vision care services to more than 16 million people in all 50 states, will begin administering vision benefits to nearly 2 million Trigon Healthcare, Inc. members in Virginia and neighboring states on January 1. Davis Vision partners with more than 14,000 ophthalmologists, optometrists and retail locations across the country.

Internet claims. Eyefinity, a Vision Service Plan-affiliated company, has launched an electronic claims submission program called eClaim. VSP, the nation's largest provider of eyecare wellness benefits is the first organization to adopt the eClaim system.

Rights granted. Allergan has been granted a license from Kyorin Pharmaceutical Co. Ltd. to develop and market the topical ophthalmic formulation of gatifloxacin, a next-generation quinolone antibiotic, in all countries except Japan, China, Taiwan and Korea.

Partnership. The American Society of Ophthalmic Administrators (ASOA) and the Joint Commission on Allied Health Personnel in Ophthalmology (JCAHPO) are initiating a continuing education program for clinical and surgical personnel. The first jointly sponsored workshop will take place next spring in San Diego.

Appointed. Clement Patry, a 21-year veteran of the optical industry, has been named director of North American sales for Gerber Coburn. The company is the world's largest provider of computer-integrated ophthalmic lens processing systems.

STAAR surge. STAAR Surgical says August sales of its Toric Intraocular Lens were up almost 70% when compared to July numbers. Average weekly sales of the new technology IOL (NTIOL) were more than $76,000 in August vs. about $45,000 in July, according to the company.

Acquisition. Invicta Corporation's EyeAmerica, Inc. subsidiary has acquired Biz Auctions, Inc. ,a pioneer in the business-to-business e-auction format for the ophthalmic industry. Biz Auctions operates the OpticalAuctions.com and OpticalMall.com Web sites.

Adds center. AmSurg is now the majority owner of an ophthalmology ambulatory surgery center in Dothan, Ala. The center is the third AmSurg has purchased from Physicians Resource Group as part of an agreement between the two companies. The others are in Las Vegas, Nev., and New Orleans.

Inspire goes public. Inspire Phramaceuticals, currently in Phase II clinical trials with a drug to treat dry eye, recently became a publicly traded company under the NASDAQ symbol "ISPH." Inspire, based in Durham, N.C., has a dry eye treatment based on activating receptors on the inner surface of the eyelids to stimulate the secretion of natural tears.

REFRACTIVE SURGERY UPDATE

Nidek patent. Nidek received "notice of allowance" from the U.S. Patent & Trademark Office for an application to use its excimer laser technology in correcting monogenic myopic astigmatism and compound astigmatism. The new correction method, invented by Arturo Chayet, M.D., enables varied (instead of uniform) tissue ablation for astigmatic corneas. The notice is the final step before patent approval.

Sales increase. LaserSight says it sold 49 of its LaserScan LSX excimer laser systems during the first half of 2000, or 48% more than in the same period a year ago. The company is still awaiting word on its application to the FDA to approve the LSX for treatment of astigmatism.

Opening. LCA-Vision opened two new LasikPlus laser vision correction centers in September -- in Atlanta and Alexandria, Va. These centers are in markets that the company has targeted for expansion.

Suing. Michael Henderson, co-founder and former CEO of Lasik Vision, recently brought a $2 million lawsuit against the company for wrongful dismissal and medical negligence. Henderson, who lost a battle for control of the company earlier this year, alleges that the company's co-founder and medical director, Hugo Sutton, M.D., damaged his eyes with laser surgery. Lasik Vision and Dr. Sutton deny the charges.

Suit settled. Lasik Vision has reached an out-of-court resolution of its 1998 defamation lawsuit against TLC Laser Eye Centers. Terms of the settlement were not disclosed.

TruVision agreement. TruVision now provides discounted LASIK vision correction to members of South Carolina Blue Cross and its subsidiary health plans for $799 an eye.

Online discounts. ICON Laser Eye Centers has begun to offer laser vision correction at a significant discount to standard industry rates through HealthAllies.com, an online company that offers pre-negotiated rates for specific routine and elective healthcare services.

Corneal analysis. LaserSight received a notice of allowance from the U.S. Patent & Trademark Office for a method of corneal anlysis using a checkered placido apparatus. The company sees this method as being valuable in custom corneal ablations, as it more accurately determines the shape of the cornea, particularly those that exhibit irregular surface topographies.