Lucentis credited with restoring vision for many with macular degeneration.

(The Morning Call Inc., Copyright 11/21/06)

By Ann Wlazelek Of The Morning Call

Lying on his back with an "X" drawn above his left brow and his eyelids held back, 69-year-old Ernie Davis looks up and to the right as his doctor uses a cotton swab and drops to clean and numb the white part of his left eye.

" A little pinch," Dr. Andy Kimmel says as he inserts a needle into Davis' eyeball and injects a few drops of a solution called Lucentis.

The retired accountant from Hellertown doesn't flinch. This is his seventh injection at St. Luke's Hospital-Fountain Hill. And as horrifying as having a needle stuck in your eye may sound, it's been worth it.

Davis has macular degeneration, a progressive disease that is the leading cause of blindness. After only two injections of Lucentis, he could see letters on an eye chart that before looked like a gray blur.

Lucentis, approved by the U.S. Food and Drug Administration in June for patients with the so-called "wet" form of macular degeneration, is being hailed by doctors here and across the country as a major breakthrough in treating blindness.

Some 10 million people suffer from macular degeneration; about 2 million of them have the "wet" form that Lucentis can help. And as more baby boomers move into their senior years, millions more will begin losing their eyesight to the disease. But until now, there's been no known cure and treatment options left patients less than satisfied.

Not only can Lucentis prevent the progression of the disease, it can restore vision. Results from two studies published in October in the New England Journal of Medicine showed that among more than 700 patients treated over two years, Lucentis stopped vision loss in 95 percent of patients and improved vision in one-third.

Dr. Maz Kazahaya, chief of ophthalmology at Lehigh Valley Hospital It might not work on patients with the most advanced form of the disease, those who've had it for 10 years or more.

And the drug is not without side effects, including serious infections, cataracts and retina detachments.

Still, Kazahaya said, any eye specialist not offering Lucentis "is doing patients a disservice."

Macular degeneration is a condition in which the macula, or center-most part of the retina, deteriorates. The retina is the movie-screen-like surface at the back of the eye upon which images are projected.

Heredity, smoking, obesity and high blood pressure are believed to contribute to the condition.

Early symptoms include distorted vision, in which a straight line looks wavy, and a dark blotch at the center of vision. If the condition progresses and tiny new blood vessels grow into the retinal wall and bleed, it is considered "wet" macular degeneration.

Not everyone who has "dry" macular degeneration will get the "wet" form, experts say, but those who do generally see it happen around age 70.

Lucentis works by killing off the new blood vessels growing and bleeding into the retina. It is made by Genentech, a biotechnology company in South San Francisco, Calif.

Before Lucentis, patients with macular degeneration underwent photodynamic therapy, a laser treatment to seal leaky blood vessels, or they were given the drug Macugen, said Dr. George A. Williams, a retina specialist in Royal Oak, Mich., and spokesman for the American Academy of Ophthalmology. They slowed the disease and prevented severe vision loss in most patients.

"But still, many felt their vision was quite poor," Williams said.

Another option was Avastin, a cancer drug also made by Genentech If Avastin proves just as effective, it would mean a huge savings. Avastin costs $50 a dose, compared with Lucentis' $1,950 price tag.

Health care plans cover Lucentis. For those whose plans don't or who can't afford co-payments to doctors and hospitals, Genentech provides the drug free or refers patients to some charities known to help.

Kimmel started giving the injections in August and already has more than 70 patients on the drug. He injects one eye per visit at St. Luke's retina center in Fountain Hill, then schedules a follow-up visit in his office the next day. For patients with the disease in both eyes, that means twice as many visits.

On a recent Monday morning, he gave injections to a dozen patients at the St. Luke's retina center before starting office hours across the street.

Kazahaya said he gives injections to about five patients each day.

"So many patients have wet macular degeneration," he said. Genentech recommends that patients receive one injection a month in each eye with the disease for a year, with monitoring to continue beyond that. For patients, the biggest barrier is not the newness of the drug or the price tag. It's the way it's administered.

"Just the thought of getting an injection in the eye is psychologically hard to grasp," Kazahaya acknowledges. "But once they have it done, they say it wasn't so bad.

"The second [shot] becomes easier and after the third or more, when they've seen improvement in vision, they want it."

A number of Kimmel's patients agree.

"I'll take anything as long as I can see," said Chester Feidler, 78, of South Whitehall Township.

When diagnosed in September, Feidler said he could not see well enough to distinguish what was on his dinner plate. "I was embarrassed if I got prime rib because I couldn't tell where the fat was," he said.

But after the second shot in his right eye earlier this month, Feidler was no longer "legally blind" in that eye and could clearly see his food. "I was tickled," he said. Pat Brown, a 69-year-old semiretired high school "lunch lady" from Phillipsburg, said she was "scared to death" of getting a needle in the eye. Now that she's had three, she's no longer afraid.

"It does not hurt," she said. "Unbelievable."

Although Brown didn't feel pain, she did see specks, sometimes called "floaters," from the injected solution immediately after the shot, like many other patients.

Brown likened the effect to looking through a kaleidoscope. The squiggly shapes and colors typically last a few hours or till the next day.

The desired effect of better vision occurred after the second injection in her right eye, she said. The fuzzy black spot blurring the center of her vision had disappeared.

"Dr. Kimmel has given me some of my sight back," Brown said. Davis, who has had the disease for five years, said two injections were all it took to improve his vision by two lines on the eye chart. The improvement is to his "good" eye, not the "bad" one, but

Davis is thrilled nonetheless.

"My wife and I are extremely happy with these results," he said. The injections "are saving my vision from getting any worse."

As they treat more patients with Lucentis, doctors are still trying to determine which patients will respond best.

Williams, who works at the William Beaumont Hospital in Royal Oak, said he's treated more than 100 patients since the beginning of July. "The drug works best early in the disease," he said. "I tell patients that if they have had poor vision for a long time, maybe 10 years or more, it is unlikely this will be a big benefit to you."

Fairly often, he turns such patients away.

"Lucentis is not for everybody," Kazahaya said. "It's only for those with active disease. It there's scarring already, Lucentis won't reverse that." Research trials didn't include such patients, he said.

But because Lucentis hasn't been tested on many advanced-stage cases and patients react differently, Kimmel said he doesn't want to turn someone away who might benefit.

"The really bad cases, who have had macular degeneration a long time, I wish I had had earlier," he said. "But I am willing to offer it. No one has the data to show if it's efficacious or not."

Kimmel said he's seen Lucentis work on patients, such as Madeline Walsh of Bethlehem, who have had the disease for four to five years.

Walsh said at a recent visit at St. Luke's that she could see the numbers on her alarm clock after her second injection.

"The only problem with that," a nurse quipped, "is now you have to get out of bed."

SEEING SUCCESS

Studies show Lucentis stopped vision loss in 95 percent of patients and improved vision in one-third.

Source: New England Journal of Medicine Copyright © 2006, The Morning Call

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