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FDA Approves Focus Night & Day Contact Lenses for 30-Day Continuous Wear
CIBA Vision Sees the Product as an Alternative to LASIK.

The FDA has approved CIBA Vision's Focus Night & Day contact lenses for 30 days and nights of continuous wear. The Night & Day lenses are the first high-oxygen, extended wear soft lens to receive this wearing indication in the United States.

The lenses became available to eyecare practitioners on a limited basis on Nov. 1. CIBA Vision says they are priced competitively with disposable contact lenses currently on the market.

Stuart Heap, president of CIBA Vision's global lens business, called the Night & Day lenses "a breakthrough product" and "the most significant advancement in contact lens materials since soft lenses were introduced more than 30 years ago."

Heap also sees the lenses as potential competition to laser vision correction surgery.

"There are millions of individuals who desire around-the-clock clear vision but who aren't good candidates for the (LASIK) procedure, or who are averse to it because of its high cost, invasiveness, non-reversibility and potential complications," he noted. "Night & Day lenses are a good alternative for these people."

According to CIBA Vision, Night & Day lenses are made from a silicone hydrogel material that supplies six times more oxygen to the eye than ordinary disposable lenses and 40% more oxygen than the minimum threshold recognized by independent researchers for overnight wear. The company says in research studies, patients wearing Night & Day lenses experienced minimal corneal swelling (comparable to wearing no lens at all) and significantly less limbal redness than is typically seen with soft contact lens wear.

Since 1999, about 250,000 people in more than 40 countries outside the United States have worn Night & Day lenses for up to 30 continuous nights and days. In addition, CIBA Vision has compiled more than 2,000 patient years of study for the product. 

Court Says O.D.s Can't Perform Invasive Surgery
Procedures at Issue in N.Y. Include Punctal Occlusion.

When the New York State Health Department announced last year that Medicaid would begin reimbursing optometrists for performing 13 specific procedures, Robert J. Kennedy, M.D., president of the New York State Ophthalmological Society, decided he would fight what he believed was an invitation for optometrists to perform three invasive surgeries that are outside optometry's scope of practice.

Recently, Dr. Kennedy's legal complaint was upheld when New York State Supreme Court Justice Joseph R. Cannizzaro ruled that optometrists may not perform the three procedures: closure of lacrimal punctum by plug, probing of nasolacrimal duct with or without irrigation, and probing of lacrimal canaliculi with or without irrigation.

Judge Cannizzaro ruled that these procedures all constituted invasive surgery and were outside of optometry's scope of practice, as defined in State Education Law 7101. He enjoined the state from using Medicaid funds to reimburse optometrists for performing these three procedures.

"The state statute expressly prohibits optometrists from invasive modalities," says B.J. Costello, the attorney who presented Dr. Kennedy's case before Judge Cannizzaro. "And there's no question that these procedures all involve the tearing of flesh. Dr. Kennedy felt very strongly about this issue and he stepped up as a taxpayer and an ophthalmologist."

Ophthalmologists Treat Hundreds After Trade Center Attacks
Volunteers Worked for 3 Days at "Ground Zero"

Ophthalmologists and eyecare companies distinguished themselves in the aftermath of the terrorist attacks on New York City's World Trade Center towers on Sept 11. While doctors worked steadily for days, first at nearby hospitals and then later at "Ground Zero" to treat the eye problems of a number of victims and hundreds of rescue workers, companies rushed truckloads of eyecare products to the scene.

	Emergency supplies destined for "Ground Zero" eyecare stations await shipment in a Bausch & Lomb warehouse.

Doctors from the New York Eye & Ear Infirmary, located less than 2 miles north of the World Trade Center towers, were among the first to treat those who sustained eye injuries in the explosions. Working at their own facility and assisting at Beth Israel and St. Vincent's hospitals, physicians from New York Eye & Ear treated more than 100 people for corneal abrasions, foreign bodies in the eye and eye irritation on Sept 11. Almost all of these individuals were police and fire personnel.

Paul T. Finger, M.D., was among the ophthalmologists who volunteered at Bellevue Hospital on Sept. 11.

"We saw numerous corneal abrasions due to concrete dust among the rescue workers," says Dr. Finger. "The dust was very basic and melted the corneal epithelium. We irrigated them, and gave the patients cyclopegics, steroids and antibiotics as needed."

The next day, eyecare stations were set up closer to Ground Zero so that rescue workers experiencing eye irritation from the smoke, dust and debris that pervaded the area could be treated without having to travel to a hospital. For 3 days, teams of volunteer ophthalmologists and nurses from New York Eye & Ear, St. Vincent's, Weill Cornell Medical College, Manhattan Eye & Ear and other medical facilities throughout the metropolitan area worked 6-hour shifts around the clock at four eyecare stations to treat hundreds of rescue workers. Several rescue workers with corneal abrasions were referred to nearby hospitals.

Photo courtesy of Michael Becton. Bellevue Hospital medical teams wait for patients from World Trade Center tragedy.

The ophthalmology teams brought some supplies with them to the Ground Zero sites, but these were soon augmented with large donations of supplies from eyecare companies, volunteer health projects and private medical facilities.

Among the many eyecare companies making contributions of supplies were Bausch & Lomb, CIBA Vision, Allergan, Alcon, Pharmacia, Merck, Roche Group, Johnson & Johnson, Luxottica and Safilo USA, which donated more than 2,200 pairs of Smith and Carrera goggles and sports shields for use by rescue and recovery workers.

In a related development, the World Trade Center tragedy resulted in the cancellation of numerous meetings and events, including Vision Expo West, which had been scheduled for Las Vegas, Nev., in late September. Vision Expo West 2002 will be held at the Sands Convention Center in Las Vegas next Sept. 12-14.

IN THE NEWS

Glaucoma treatment. CIBA Vision has acquired worldwide marketing and distribution rights to CellPlant, a device to relieve intraocular pressure that's inserted during standard filtration surgery in glaucoma patients. The device, developed by Wound Healing of Oklahoma, Inc., allows fluid egression through fibrovascular channels surrounding the device. CellPlant is still in clinical trials.

Glaucoma detection. InSite Vision has launched the OcuGene test for the early prognosis and diagnosis of primary open angle glaucoma. The test uses genetic markers to detect the disease in patients who may not be symptomatic, and also helps identify individuals who have an aggressive form of the disease.

Alcon IPO. Nestle SA says it would sell about 25% of its Alcon eyecare business if it decides to do a partial initial public offering of the unit next year. Analysts' estimates of Alcon's total worth vary widely. One analyst puts the overall value of Alcon at $12 billion, excluding debt, while another places its worth around $7 billion.

Companies donate. Volk Optical, Essilor, PRIO, Cadore Moda, Quality Accessories and Breitfeld & Schliekert are among the eyecare companies donating either cash or a percentage of sales to organizations involved in the New York City relief and recovery effort.

B&L acquisition. Bausch & Lomb has acquired Pharmos Corporation's loteprednol etabonate ophthalmic business, including all rights to loteprednol etabonate ophthalmic suspension 0.5% (Lotemax), the leading ophthalmic steroid, and loteprednol etabonate ophthalmic suspension 0.2% (Alrex), a treatment for seasonal allergic conjunctivitis. The acquisition also includes any future extensions of loteprednol etabonate formulations.

Vitamin Supplements Can Limit AMD Damage
Major Study Finds Benefits in More Advanced Cases.

Recently released findings from the National Eye Institute's (NEI) Age-Related Eye Disease Study (AREDS) indicate that a combination of antioxidants and zinc supplements can be effective in reducing the risk of developing advanced stages of age-related macular disease (AMD) by 25%. In the study, the supplements reduced the risk of actual vision loss by 19%.

"This is an exciting discovery because, for people at high risk of developing advanced AMD, these dietary supplements are the first effective treatment to slow the progression of the disease," said Paul A. Sieving, M.D., Ph.D., director of the NEI. "The supplements aren't a cure for AMD, nor will they restore vision already lost from the disease. But they will play a key role in helping people at high risk for developing advanced AMD keep their vision."

The multi-year research project, involving almost 5,000 people between 55 and 80 years old, also found that study participants who had either no AMD or early AMD derived no apparent benefits from taking the supplements. The vitamins appeared to have no effect on the development of cataracts.

The supplement used in the study contained Vitamins C and E, beta-carotene, zinc and copper. Bausch & Lomb, which provided the vitamins for the study, is now marketing the supplement over the counter as Ocuvite PreserVision. The recommended dosage is two tablets, twice a day, which equals the dosage used in the study.

Two AMD Treatments Receive New Reimbursements
Noridian Will Pay TTT Medicare Claims in 11 States; Visudyne Coverage Expanded.

Noridian Mutual Insurance, a Medicare Part B carrier for 11 western and midwestern states, has become the first Medicare carrier to cover transpupillary thermotherapy (TTT) procedures administered to treat patients with choroidal neovascularization (CNV) secondary to wet age-related macular degeneration (AMD).

As you know, TTT is a minimum-intensity laser photocoagulation protocol that can result in closure of CNV with relative sparing of the neurosensory retina compared to conventional laser photocoagulation techniques.

The written ruling states that coverage is effective for dates of service on or after May 1 of this year. Previously, TTT had been reimbursible only on a case-by-case basis, and only in some states. That situation remains in effect for the states outside of Noridian's coverage area.

The states included in Noridian's coverage area are Alaska, Arizona, Colorado, Hawaii, Iowa, Nevada, North Dakota. South Dakota, Oregon, Washington and Wyoming.

"We look at Noridian's action as a very significant development," says Heather Freeland, director of coding and compliance for Rose and Associates, healthcare consultants located in Duncanville, Texas. "Ophthalmologists in the other 39 states now have more leverage in obtaining Medicare reimbursement for providing TTT treatment."

TTT will be covered by Noridian for diagnoses described by either ICD-9-CM codes 362.51 or 362.52 and can be billed using HCPCS code GO185, pending approval of a specific CPT code. Reimbursement varies from $670 to $704, depending on geographic location.

In a related action, the Centers for Medicare and Medicaid Services (formerly HCFA) announced that reimbursement for verteporfin for injection (Visudyne) will be expanded to include treatment of occult-only subfoveal CNV secondary to wet AMD.

The decision is a result of a formal request by the Vitreous Society and consultations with physicians, clinical investigators, Novartis Ophthalmics and QLT Inc.

REFRACTIVE SURGERY UPDATE

Custom ablation. Nidek Co., Ltd is now offering the Nidek Advanced Vision Excimer Laser System (NAVEX) for international sale. NAVEX includes four components that together provide the necessary technology for performing customized ablation with the Nidek EC-5000 excimer laser system. The components include an eye-mapping instrument and accompanying software (below), an eye tracker system and a segmental ablation system that directs the excimer laser beam to small, specific areas of the corneal surface.

Agreement. LaserSight has granted a nonexclusive license to Bausch & Lomb to use LaserSight's patented scanning technology in exchange for an initial $3 million lump sum licensing fee and possible future fees that could total as much as $2 million. The technology involved is covered under LaserSight's 679 scanning patent.

VISX downturn. VISX, Inc. said the severe economic downturn has resulted in a 25 to 30% sequential decline in its licensing revenue, as well as lower domestic and international equipment sales. VISX said consumers are postponing elective laser vision correction procedures because of the current economic uncertainty.

LASIK pricing. LCA-Vision, a provider of laser vision correction services, reported that its average procedure price increased to $996 in the 3 months ending Sept. 30 from $934 in the previous 3 months. However, the company cited a weak economy and the events of Sept 11 as reasons for an 18% year-over-year drop in procedure volume.

LaserScan approved. The FDA has approved LaserSight's LaserScan LSX precision microspot scanning excimer laser system for LASIK treatment of myopia with and without astigmatism. Approval is for a range of treatment of refractive errors up to -6.00 diopters manifest refraction spherical equivalent with or without a refractive astigmatism up to 4.5 diopters of cylinder.

Study Warns Against PRK After LASIK
It Can Make Undercorrected Myopia Even Worse and Cause Dense Haze.

Italian researchers who studied 17 patients who had undergone PRK in an attempt to correct undercorrected myopia after LASIK found that the PRK treatment caused further myopic regression and dense corneal haze that further compromised their vision.

Ernest Kornmehl, M.D., warns doctors that PRK shouldn't be performed after LASIK.

The researchers have cautioned against using the PRK procedure to re-treat LASIK patients.

"Fortunately, most experienced refractive surgeons are already aware that they shouldn't perform PRK after LASIK, but this study should make it clear that this course of treatment should be avoided," says Ernest Kornmehl, M.D., medical director of Kornmehl Laser Eye Associates in Boston.

The Italian study involved the PRK re-treatment of 17 eyes of 17 patients, all of whom had experienced myopic regression or undercorrection after LASIK. These patients weren't good candidates for LASIK re-treatment because they had thin corneas.

Although initial refractive results from PRK were satisfactory, follow-up examinations at 3 and 6 months showed that dense haze had developed in 82% of the eyes, accompanied by myopic regression and loss of best-corrected acuity. These eyes underwent further surgical treatment 3 to 10 months later to remove the severe haze.

"We can't be certain why the severe haze develops after PRK," says Dr. Kornmehl, "but the most reasonable explanation is that the keracytes activated during the healing period following LASIK may stimulate more aggressive wound healing after PRK, resulting in the deposition of collagen, proteoglycans and hyaluronic acid which are responsible for the haze."

The study's authors say that patients with thin corneas who have undergone LASIK can safely be re-treated with other procedures, including intrastromal ring segments and "mini" radial keratotomy, using very small, spoke-like incisions.