By Susan Jenks - Florida Today
July 18, 2006

A newly approved drug for a leading cause of legal blindness in the United States packs a "wow factor" when it comes to improving patients' vision, according to several eye doctors.

"The average person's vision gets better with Lucentis," said Dr. Adrian Laviña, a West Palm Beach ophthalmologist and retina specialist, referring to the Genentech drug, which gained marketing approval for the treatment of age-related macular degeneration from the U.S. Food and Drug Administration in June.

"And the safety profile is excellent," said Laviña, whose group, Retina Care Specialists, took part in early research studies.

But Lucentis also carries a relatively high price tag -- $1,950 per injection -- $950 more than Macugen, a competing drug, and nearly six times more than Avastin, another Genentech drug doctors use primarily to treat colon cancers, but also sometimes use "off-label" for advanced stages of the incurable eye disease.

Off-label usage refers to another medical use other than that approved by the federal agency -- a common practice in health care today.

"Nothing prevents us from using Avastin in the eye off-label," said Dr. John Olson, an eye doctor with Orlando-based Central Florida Retina, with a Rockledge office. "The difference is now we have hard evidence Lucentis works, while it's more anecdotal that Avastin works in the eye."

Recent clinical research studies, Olson and others said, show Lucentis brings measurable vision improvement for the first time to some patients with age- related macular degeneration. After treatment, 35 percent to 40 percent of patients could read at least three additional lines on an eye chart, the studies found, while 90 percent to 95 percent saw stabilization of their disease.

With other eye drugs, Olson said, "we showed vision loss did not occur as quickly, but there was no real vision improvement, either."

Doctors diagnose an estimated 200,000 Americans annually with age-related macular degeneration, which, as its name suggests, strikes mostly individuals 60 or older.

The disease occurs when abnormal blood vessels form at the back of the eye, distorting and scarring a tiny sliver of tissue at the center of the retina, which controls central vision and fine-detail tasks, such as reading, driving, watching television or telling time.

As these fragile blood vessels multiply and grow, the eye disease turns from "dry" to "wet," an advanced form, occurring in about 10 percent of patients.

'Superb results'

In Brevard County, several local eye doctors indicated they are not averse to using Lucentis, although it has not yet arrived in their offices. But they said they have used Avastin off-label for at least a year, with impressive results.

And it's cheaper, they claim, because eye treatments require one-500th of the dose needed for cancer, thus stretching supplies over time.

"I'm using Avastin like it's aspirin for a multitude of (retinal) treatments," including diabetic retinopathy and macular degeneration, said Dr. Paul Befanis, medical director of Brevard Eye Center in Melbourne. "And we are seeing superb results."

Befanis said one patient he recently treated now reads six additional lines on an eye chart, while others show similarly dramatic improvements.

Dr. Gary Ganiban, an ophthalmologist at the Eye Institute for Medicine and Surgery in Melbourne, described Avastin as "the best drug yet."

Of 300 eye patients treated in the past year, he said, 90 percent have stable vision, and -- like Lucentis -- 35 percent to 40 percent have improved vision.

"They can read again," Ganiban said. "Using it has made my job more enjoyable."

But while "Lucentis went through vigorous FDA approval for the eye, nobody has looked at Avastin this way," he conceded, so the problem becomes -- in theory, at least -- what if something goes wrong?

Drug similarities

According to Dawn Kalmar, a spokeswoman for California-based Genentech, Lucentis and Avastin are different drugs and not, as widely reported, one drug derived from the other.

Lucentis is "not a fragment of Avastin," she said, even though the two drugs work similarly to block high levels of a protein that stimulates abnormal blood vessel growth.

"Avastin was approved as an intravenous drug," she said, designed to stay longer in the body to disrupt the blood supply of tumors, while Lucentis works as an "ophthalmic drug," which must be administered repeatedly to do its job.

"We anticipate patients will need five to seven treatments," she said, although doctors say they tailor injections to individual patient need.

As to costs, Kalmar said, the $1,950 price tag per injection applies only to physicians' wholesale costs, which Medicare and other insurers began covering, once Lucentis gained approval for marketing.

And patients' out-of-pocket expense, on average, she said, should run about $50 per treatment, comparable to Avastin's in the eye, with those needing financial help able to get it through the company's patient assistance program.

However, Medicare spokeswoman Lee Millman said Medicare coverage is neither legally required nor automatic after FDA approval of a drug, and there has been no national decision on whether or not to cover Lucentis.

She suggested consumers call 800-633-2272 or contact their health care provider to see whether federal insurance is available.

Patient response

For Micco resident Rita Uterstaedt, no matter what Lucentis' future price, she will find some way to pay for it, she said.

"I've come this far, so I'll continue," she said. "Otherwise, I would lose my quality of life."

Ever since participating in a two-year research study of Lucentis, Uterstaedt said, her vision has improved so much she can read, drive and even do word puzzles, which she loves.

And the monthly injections at Laviña's West Palm Beach office -- one of 100 test sites nationally -- never bothered her.

"When your eyesight is so bad -- as bad as mine -- you don't even see the needle coming," the 68-year-old Uterstaedt said with a laugh. "Years ago, there was no hope. I was just delighted to get this."

Josephine Artemik, treated by Olson in Orlando just last week, also found the experience "terrific."

Although improved visual acuity probably won't kick in for several weeks, she was told, the procedure appeared to go well and, "except for a little bite," she barely felt the needle as it pierced her eye.

"I'm glad doctors train to do these things for all us oldies," the 83-year-old St. Cloud resident said. "I'm game to try anything that might work."