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Gene Therapy Restores Sight to Blind Dogs
Researchers See a Breakthrough in Treating Hereditary Vision Diseases.

"Bill, Bill, the dogs can see!"

With these six simple words, William Hauswirth, a professor of molecular genetics and microbiology at the University of Florida College of Medicine, learned that researchers from his team had succeeded in using gene therapy to restore vision to three Briard puppies that had been blind since birth with the canine version of Leber congenital amaurosis (LCA). About 10,000 people in the United States have LCA, a currently untreatable condition caused by a genetic defect that leads to blindness at birth or during infancy.

The healthy RPE65 genes being implanted.

"In other eye diseases, we've been able to use gene therapy to prevent worsening of the condition in animals," said Hauswirth, but this is the first time we've been able to recover a lost function."

If the gene therapy is proven effective in human LCA patients, it may have potential for treating a variety of forms of retinitis pigmentosa, which affect about 150,000 Americans, researchers said. Initial studies with humans could begin in about 2 years.

The tests involving the dogs were conducted at the Scheie Eye Institute of the University of Pennsylvania and reported in the May issue of Nature Genetics. The puppies couldn't see because inbreeding had left them with a blinding mutation of the RPE65 gene, identical to the one that can be identified in about 20% of human LCA cases.

	Lancelot can now see out of his right eye.

Scientists were able to genetically engineer viruses containing healthy versions of the RPE65 gene and inject thousands of these viruses into each dog's right eye, behind the retina. Within weeks, the corrective genes had done their work and given the dogs significant and sustainable vision in their right eyes.

During tests, the dogs were able to navigate through a maze, even in dim light. They would turn their heads to the right to use the eye that had been treated.

"They bumped into objects on the left, but would always avoid the objects on their right, said Hauswirth.

Shop Around for Malpractice Insurance
Rates Vary for Eye MDs.

While obstetricians, orthopedists and neurosurgeons in many parts of the country are seeing their malpractice insurance premiums skyrocket, ophthalmologists with relatively clean claims records should be able to purchase insurance at acceptable rates this year.

"We're raising our rates by 7 1/2 % in July," says James F. Holzer, president and CEO of Ophthalmic Mutual Insurance Company (OMIC). "We've been able to maintain stable rates because we insure only ophthalmologists and our claims frequency remains low. The problem for many ophthalmologists this year is that their carriers are imposing large, across-the-board increases for all specialties and the ophthalmologists are being caught up in this environment. If you're being hit with a big increase, this may be a good year to shop around. Look for a company with a history of stable rates and strong financial performance. A number of companies meet these criteria."

Holzer says ophthalmologists insured by his company are paying an average of about $7,000 for malpractice insurance this year, with a range of $3,000 in parts of the South and Midwest, to $18,000 in certain areas of Florida and New York.

"If you're not doing surgery, you can obtain a much lower rate," says Holzer. "And if you're in a large group practice, your group probably has some leverage in negotiating a lower rate with your insurance carrier."

Holzer says OMIC hasn't seen a large increase in malpractice claims related to refractive surgery, but he says that may be due to a comprehensive risk management program that requires OMIC-insured practices to observe strict standards in screening candidates for refractive surgery and obtaining their informed consent.

"Refractive surgery is something we're watching closely," Holzer concludes. "You can't assume it won't become a problem area in the future."

IN THE NEWS

• Glaucoma laser. Coherent Inc. has FDA clearance to market its Selecta 7000 glaucoma laser system. The system performs Selective Laser Trabeculoplasty, using pulses of low-energy light to target melanin-containing cells in the trabecular meshwork without the risk of scarring.
• Visudyne effectiveness. An extended Phase III study of more than 400 AMD patients demonstrated that the average visual acuity of individuals treated with Visudyne remained stable during the third year of treatment even though the frequency of treatments was reduced.
• New product. STAAR Surgical has licensed the marketing rights to STAARVISC II, a viscoelastic substance primarily used during cataract procedures, from Anika Therapeutics Inc.
• Inspire trials. Inspire Pharmaceuticals Inc. reported positive results from Phase II trials of its INS365 ophthalmic solution for treatment of dry eye. Phase III trials are currently under way. Inspire has also launched Phase I/II clinical trials for INS37217 ophthalmic intravitreal injection for the treatment of retinal detachment.
• Distribution agreement. American Optisurgical Inc. has granted Moria, Inc. exclusive North American rights to distribute the MK Quick Rinse for washing, rinsing and drying microkeratomes and other surgical instruments prior to sterilization.
• Research funding. Bausch & Lomb will provide the University of Rochester ophthalmology department with $5 million in cash and equipment over the next several years to create a leading research and clinical hub.
• Xalatan growth. Pharmacia Corporation said sales of its glaucoma medication Xalatan increased to $200 million in the first quarter of 2001, a 24% jump over the same quarter a year ago.

Ophthalmologists Split on TV Prescription Drug Ads
Some See Ads as Educational; Others View Them as a Nuisance.

Over the past few years there's been a growing trend toward pharmaceutical companies advertising prescription drugs on television. For example, Alcon Laboratories has been running TV ads for its eye allergy medication, Patanol (olopatadine hydrochloride), for the past 4 years. This "direct-to-the-consumer" approach for marketing medications that can only be prescribed by a physician has raised questions.

Are the companies promoting a positive form of patient awareness? Or are they trying to go "over the heads" of doctors by having patients specifically request certain drugs?

The companies say they use direct-to-consumer advertising for two reasons. One, it allows them to increase public awareness of the specific products they choose to advertise. And two, the ads have resulted in increased sales for those products. The companies point out that the product ads are carefully reviewed by the FDA and must inform consumers of any possible negative side effects.

"Sure, we're encouraging people to ask their doctor about our product," says a marketing executive for a major pharmaceutical firm. "But we recognize that all decisions on patient care belong to the physician. If our ads bring people into doctors' offices and encourage a physician/patient dialogue, it's a good thing."

Ophthalmologists appear to be split on the value of consumer-oriented ads.

"I'm very opposed to drug companies telling my patients what medicines I should be prescribing," says Larry Patterson, M.D., a Tennessee ophthalmologist. "It interferes with my doctor/patient relationship."

"An informed patient is a better patient," counters Frank J. Weinstock, M.D., F.A.C.S., who teaches and practices ophthalmology in Canton, Ohio. "Consumer advertising can make a patient aware of his eye problems and cause him to seek treatment."

"My patients don't know enough about the condition they have to ask for a specific medication," says Bill Hart, M.D., a Lake Charles, La., ophthalmologist. "I prefer to prescribe the least expensive agent that can do the job."

Florida Co-Management Legislation is in Limbo
"We Didn't Have the Votes," Says Sponsor.

A controversial piece of legislation that could have ended co-management in Florida was tabled by its sponsor amid a flurry of amendments and charges that the legislation was politically motivated.

The bill, which would have banned nonphysicians from providing follow-up care to ocular surgery patients, had the backing of the American Academy of Ophthalmology, the Florida Society of Ophthalmology and the Florida Medical Association. It was strongly opposed by the International Society of Refractive Surgery and the Florida optometry community. The American Society of Cataract and Refractive Surgery took no position on the issue.

"I thought we had the votes, but we didn't," said Rep. Mike Haridopolos, the sponsor of the bill in the Florida House of Representatives. Haridopolos gave no indication of whether the bill would be brought up again in the next session of the legislature.

Last-minute attempts to soften the bill couldn't change its fate. One amendment offered in the House sought to allow co-management of only cataract patients at 14 days post-surgery. Another called for a 7-day post-op period before an optometrist could become involved. But key lawmakers said they saw no evidence that existing co-management arrangements were a problem.

Proponents of the bill, which included Alan Mendelsohn, M.D., a Broward County ophthalmologist and prominent political fundraiser, had charged that co-management was causing ocular surgery patients to seek help in hospital emergency rooms. That claim was strongly disputed by the bill's opponents.

REFRACTIVE SURGERY UPDATE

• Increased pricing. LCA-Vision, a provider of laser vision correction services, reported that its average price per procedure rose to $897 in the first 3 months of this year, compared to $877 in the last quarter of 2000.
• B&L trials. Bausch & Lomb has begun clinical trials for its Zyoptix system for personalized laser vision correction. Using advanced diagnostic tools to determine the unique features of each eye, the Zyoptix system integrates both topographic and wavefront diagnostic information for customized laser vision correction.
• Surgeons assist. Eight California refractive surgeons formerly employed by now-bankrupt Lasik Vision say they will assist former Lasik Vision patients who require follow-up care. The surgeons, who claim Lasik Vision still owes them back pay, say it's their ethical obligation to provide or facilitate treatment for former Lasik Vision patients.
• Seeks approval. Nidek has filed an application requesting the FDA to expand the optical zone for myopia treatments with its EC-5000 Excimer Laser System. The EC-5000 is currently approved for a 5.5-mm optical zone with a 7.0-mm transition zone for both myopia and myopia with astigmatism. The company seeks a 6.5 mm optical zone for myopia so that it can treat a broader range of refractive errors.
• Icahn backs off. Financier Carl Icahn, who owns a 10.5% stake in excimer laser developer and manufacturer VISX, ended his attempt to elect his own slate of directors to the VISX board. Icahn says he believes the company would now welcome a $32-a-share cash takeover offer from either Icahn or another potential acquirer. Analysts believe Icahn is attempting to begin an auction process that would result in the sale of the company.