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Macular Degeneration Treatment on Fast Track for FDA Approval

Posted on: Wednesday, 14 June 2006, 06:00 CDT

FORT LAUDERDALE, Fla. _ Carole Ann Crews sat nervously in the examining room chair in December as Dr. Mark Michels prepared to inject her right eye, attempting to stem a sudden and devastating onslaught of age-related macular degeneration with an experimental drug that appears successful in clinical trials.

"As afraid as I was of having an injection in my eye, I was even more afraid of going blind," said Crews, 69, of Atlantis, Fla. "The doctor expressed hope this could help, and I prayed that it would."

Age-related macular degeneration is a disease that blurs the central vision you need for activities such as reading, sewing and driving. The disease affects the macula _ the part of the eye that allows a person to see fine detail _ and is a leading cause of vision loss in Americans 60 years old and older, according to the National Eye Institute.

It affects more than 1.75 million people in the United States, and that number is expected to increase to almost 3 million by 2020, according to the Archives of Ophthalmology.

Michels, a Palm Beach Gardens, Fla., ophthalmologist, has been treating some patients afflicted by the wet form of the disease with Lucentis, a Genentech Inc. drug that was placed on fast-track review by the Food and Drug Administration and could be approved this month.

If that occurs, marketing the drug could become a financial boon to the company, and draw patients to retinal specialists throughout South Florida and the rest of the country with renewed hope for a treatment that can save their vision.

The cost per dose is expected to be high _ perhaps in the $1,500 to $2,000 range. Genentech has discussed reimbursements with Medicare, which is expected to pay a discounted rate for treatments once Lucentis is approved.

Clinical trial results have been so strong that Wall Street analysts predict Lucentis will capture a major share of the market, generating first-year sales between $200 million and $300 million.

The strong results also prompted the FDA to allow doctors who participated in earlier trials _ in which some patients received the drug and others received a dummy "shot" _ to conduct follow-up studies with the drug before it is approved.

"I am totally excited to have been a part of this phase of the evolution of ophthalmology. I never thought I'd see this day in my lifetime," Michels said.

What Michels saw was significant improvement in patients who received the drug or appeared to receive the drug rather than a placebo. Crews' vision had deteriorated in the right eye to 20/200, meaning the smallest letter she could see at 20 feet could be seen by a normal eye at 200 feet. After three injections over a few months, her vision had improved to an almost normal 20/25.

"This is the key to Lucentis," Michels said. "Not only does it stop the wet form of macular degeneration from getting worse, but in many cases it actually improves a person's vision."

Michels and other ophthalmologists note that Lucentis appears to be superior to another approved drug for the wet form of macular degeneration, Pfizer Inc.'s Macugen, which can slow progression of the disease but does not reverse it. Some doctors also use Genentech's Avastin, a colorectal cancer drug that has not been approved for macular degeneration.

"Given that the results were so compelling, we would presume that Lucentis will be the therapy of choice (in age-related wet macular degeneration), Deutsche Bank analyst Jennifer Chao said after earlier trial results were released last year. Another alternative is Novartis' Visudyne, which when injected in the arm and combined with a laser can halt leaking of blood in the eye. But the procedure creates scar tissue, and it is often impossible to use another drug after, Michels said.

Genentech spokeswoman Dawn Kalmar said the FDA has promised to rule on the application for Lucentis approval by June 30. The drug would be shipped to wholesalers within 72 hours, she said.

Michels and other doctors note, though, that it is never too early to try to ward off macular degeneration, and they suggest considering over-the-counter supplements with nutrients shown in clinical studies to benefit the eye.

Bausch & Lomb's supplement, PreserVision, is modeled after vitamins and minerals in a major clinical trial sponsored by National Eye Institute. Two Florida firms have included those ingredients in alternative formulations: Vitacost.com sells OcuPower and VitalRemedyMD.com sells RetinGuard through physicians.

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(c) 2006 South Florida Sun-Sentinel.

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Source: South Florida Sun-Sentinel

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