Blind World

Macular Degeneration.
A new vision.

Sunday, October 17, 2004.

By Maria M. Perotin,
Star Telegram (TX).

Alcon and other companies are vying to develop products that can treat a leading cause of blindness

Her job. Her car. The morning newspaper.

One by one, Jean Russell has abandoned them all, as a chronic disease slowly has robbed her eyesight and much of her independence.

The 73-year-old Richland Hills woman has age-related macular degeneration -- a condition that leaves her peripheral vision intact but blurs whatever is right in front of her.

The disease is the leading cause of blindness among older Americans, afflicting more than 13 million people. Yet so few treatments exist that one doctor gave Russell the most dispiriting prognosis: "You're just going to have to learn to live with this."

"There was nothing they could offer me," Russell remembers. "Just nothing."

Eight years after Russell's disease was diagnosed, a handful of drug companies -- including Fort Worth-based eye-care giant Alcon -- are trying to change that.

Their researchers are racing to produce new therapies that would treat the most severe form of macular degeneration. Although none would cure the disease or restore vision, medicines could be introduced as soon as next year that aim to stem its progress.

If they succeed, the treatments would open an enormous untapped market -- estimated at upwards of $1 billion annually -- for ophthalmic companies. And they would create new hope for patients who now must resign themselves to the gradual onset of blindness.

"There's a huge unmet medical need," said Dawn Kalmar, a spokeswoman for biotechnology firm Genentech, which is developing one of the drugs. "It just so happens that all of these treatments are converging at the same time. And it'll take some time to see which one is going to be most beneficial."

For Alcon, Retaane is expected to become a significant growth driver, although the company has numerous products in its pipeline.

Only two treatments -- laser therapy and a drug-and-light combination -- exist for age-related macular degeneration, or AMD. They target the wet form of the disease that causes the most vision loss, but their effectiveness is limited and available only to certain patients.

There are no remedies for the far more common, but less severe, dry form of AMD.

Drugs await approval

New York-based Eyetech Pharmaceuticals and Pfizer are expected to push the first new drug out of the development pipeline early next year. Their treatment, called Macugen, would be injected into a patient's eye about nine times a year if it wins approval from the Food and Drug Administration.

Alcon hoped to be next to market in 2005, with Retaane -- a drug that's placed on the back of the eye every six months without actually puncturing the eyeball. But last week, the company revealed disappointing results from a clinical trial that could affect the FDA's willingness to approve Retaane quickly.

Doug MacHatton, Alcon's vice president of investor relations, said the company hopes the drug's cumulative results, especially regarding its safety, will appeal to regulators.

"This drug has proved to be very safe, a very patient-friendly application -- in terms of frequency, especially," he said.

Chip Goehring, president of the American Macular Degeneration Foundation, said those are encouraging steps.

"If these new drugs are approved and genuinely do what they're talking about, it will be great news," Goehring said. "Ultimately, of course, we'd love to find out how to stop it from happening to begin with."

Mary Schimmoller, program director at the Fort Worth office of Prevent Blindness America, said AMD sufferers routinely pepper her with questions about potential treatments. But with so few remedies to offer, she usually turns their attention instead to learning about visual aids, such as large-print books, magnifying glasses, large-screen computers and special lamps.

"It's a really devastating disease, because it strikes later in life," she said. "It's difficult to adjust. They can't drive anymore most of the time after they have it. Often, they can't read anymore or sew or do the things they'd looked forward to in retirement."

For Russell, who is legally blind with the wet form of AMD, the disease has steadily forced her to change everyday routines.

She is still able to participate in line dances with friends, attend theater performances, send e-mails and listen to audio books. But driving became too dangerous years ago, and even pouring liquid out of a bottle now is an arduous chore.

"Loss of independence is such a big thing," Russell said. "To be here with my house and my cat, and not be able to go out to the store when I want to, it's tough."

Other treatments

Goehring said AMD patients have long been frustrated by modern medicine's inability to help them. But as the huge generation of baby boomers ages and the disease becomes more prevalent even among younger patients, it has drawn more interest from researchers.

"Things that kill us get more attention than things that just make our life miserable," Goehring said. "For so long, it was looked at as a normal function of growing old."

For now, the only medicine approved for wet AMD remains Visudyne -- a drug from Switzerland-based Novartis Ophthalmics that combines a light-activated compound with a laser.

The data released last week by Alcon compared its drug with Visudyne and found that Retaane didn't perform as well as Novartis' therapy.

Still, as new treatments become available, they'll threaten Visudyne's market dominance.

Dr. Flemming Ornskov, president of Novartis Ophthalmics, said the company is ready for the competition.

It's studying additional uses for Visudyne, and Novartis will gain another foothold with the right to market Genentech's Lucentis outside North America.

"When there is additional treatment on the market, it provides -- both for the physician and for the patient -- a choice. I think that's really important," Ornskov said. "There's no single treatment that has proven to cure AMD, neither Visudyne or any of those new products."


Here is a sampling of potential treatments for age-related macular degeneration or AMD:


Description: The only approved drug for the disease, available to patients with a certain form of wet AMD. Uses a light-activated compound, combined with a laser.

Status: On the market.

Developer: Novartis Ophthalmics.


Description: Delivered every six months to the back of the eye, using a curved, blunt-tipped tube that doesn't puncture the eyeball.

Status: If the treatment wins U.S. Food and Drug Administration approval, it could be available in mid-2005.

Developer: Alcon.


Description: Injected into the eye monthly.

Status: In clinical trials. Availability date unknown.

Developer: Genentech.


Description: Injected into the eye every six weeks to treat all types of wet AMD.

Status: If the treatment wins approval from the FDA, it would be available by early 2005.

Developer: Eyetech Pharmaceuticals in collaboration with Pfizer.


Description: Biodegradable implant that releases medicine into the eye.

Status: Currently in clinical trials; expected to become available in 2007 or 2008.

Developer: Oculex Pharmaceuticals, which was acquired last year by Allergan.


Description: Drug-and-light procedure.

Status: Last month got a request from the FDA for another clinical trial.

Developer: Miravant Medical Technologies.

Maria M. Perotin, (817)685-3808

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