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HEALTH NEWS

FDA Oks Genentech's Lucentis to Treat Major Cause of Blindness

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 01 July, 2006  19:41 GMT

genentech lucentis wet form age related macular degeneration
Genentech's Lucentis not only can halt the progress of the wet form of age-related macular degeneration, but also restore sight to some patients with the disease.
Genentech's Lucentis -- a drug that eye specialists are hailing as the first treatment to improve vision in a significant percentage of elderly patients suffering from a major cause of blindness -- won federal approval Friday.

Lucentis, approved for sale by the U.S. Food and Drug Administration (FDA), is useful in treating the so-called "wet form" of age-related macular degeneration. About 200,000 people in the US are diagnosed each year with the disease, which is the leading cause of blindness in people over 55.

Halts or Reverses Disease Progression

"This is important and a major change in ophthalmology," commented Dr. Eugene de Juan, president of the American Society of Retina Specialists, who was attending an eye surgery conference in Rome. "I didn't think it was possible," he added -- until he saw evidence in studies of Lucentis' ability to reverse the effects of the disease. De Juan said he receives no money from Genentech.

Wet age-related macular degeneration results from the abnormal growth of blood vessels behind the eye. Those vessels can leak blood and other fluid, causing scar tissue that can destroy the center of the retina over time.

By inhibiting a protein believed to contribute to the formation of such blood vessels, Lucentis inhibits their formation.

In two major studies of patients suffering from the wet age-related macular degeneration, 95 percent of those given Lucentis showed no deterioration in vision over one year. Thirty-four percent to 40 percent realized improvements in their sight.

Lucentis is not designed to treat dry age-related macular degeneration, the more common and less serious form of the disease.

Treatment Could Be Very Costly

The injectable drug will not be inexpensive. The average patient probably will require five to seven doses per year, with each treatment costing $1,950, Genentech executives said. But for the typical patient on Medicare or who has private insurance, the out-of-pocket cost per treatment will be about $50, they estimate. Genentech, based in South San Francisco, has a program to provide the drug to uninsured patients for free.

Genentech's Avastin -- the company's most promising cancer-fighting drug -- already is used by some doctors to treat age-related macular degeneration. However, the FDA has not approved it specifically for that purpose. Avastin costs much less than Lucentis. Genentech executives declined to provide an estimate for the average treatment cost for Avastin, but some doctors likely will continue to prescribe Avastin as a less-expensive alternative to Lucentis.

Annual sales of Lucentis are likely to exceed $900 million by 2010, according to analysts for investment bank CIBC World Markets. Genentech's stock price rose $1.67 to $81.80 per share on the news.

Possible to Restore Vision

"We're really excited about this," said Dr. Steven Sanislo, a Stanford ophthalmologist. "This is a blockbuster drug." Sanislo helped conduct several Genentech-financed studies and is a Genentech-paid adviser.

Existing treatments -- such as laser therapy to seal leaking blood vessels and Macugen, a drug sold by OSI Pharmaceuticals and Pfizer -- can slow the degenerative consequences of wet age-related macular degeneration. But until Lucentis, restoring the sight of a patient with the disease was rare.

Lucentis "is the first drug to improve vision to this degree," said Wanda Hamilton, executive director of the non-profit AMD Alliance International, which disseminates information about the disease.

"We applaud any new treatment that brings hope and help," she added.

(c) 2006 San Jose Mercury News. All rights reserved.
(c) 2006 Daily News Central. All rights reserved.

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