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Company Keeps Cheaper Drug For Blindness Under Wraps

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The Associated Press

Published: August 28, 2008

WASHINGTON - What does a company do when there's anecdotal evidence that two of its drugs are equally effective in treating a leading cause of blindness in the elderly, one costing patients $60 per treatment and the other $2,000?

In the case of Genentech, nothing.

The company declined to seek federal approval for the cheaper drug, Avastin, to treat the wet form of age-related macular degeneration. Nor would it help finance - or cooperate with - a National Eye Institute study comparing the effectiveness and safety of Avastin, a cancer drug, and the more expensive eye drug, Lucentis.

The financial stakes stemming from the study are huge. Medicare officials estimate there could be 50,000 or more additional cases of macular degeneration a year. Treating just one year's worth of new patients with Lucentis would cost $1.2 billion a year, compared with $60 million if they were treated with Avastin, Medicare officials said.
Genentech is making no promises that it will act upon the trial's final results, which are expected in two to three years.

The company has raised concerns that safety issues were not properly addressed. In particular, the trial does not have enough patients to show some of the rare but serious side effects that could occur with use of the cheaper drug, the company contends.

"No matter the outcome, we continue to believe Lucentis is the most appropriate treatment for wet AMD," said Krysta Pellegrino, a company spokeswoman.
Wet AMD occurs when abnormal blood vessels leak blood and fluid affecting the part of the eye that allows the seeing of fine details.

Many eye doctors think Avastin works just as well in treating macular degeneration even though it has not been approved for that purpose. It is not unusual for drugs to be used off-label - treating diseases other than those the drug was approved for.

Both drugs target a protein that causes blood vessels in the back of the eye to grow, but Lucentis is a much smaller molecule. It was specifically designed - at great expense - to penetrate the retina.

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