A company's two drugs - at way different price points - tied in a study on treating macular degeneration

Maureen Maguire of Penn helped lead the drug trial.
Maureen Maguire of Penn helped lead the drug trial.
Posted: April 29, 2011

A head-to-head trial of two drugs used to treat age-related macular degeneration - Avastin and Lucentis - ended in a virtual tie, researchers announced Thursday.

"The two drugs give nearly identical results when given in the same way," said Maureen Maguire, a professor of ophthalmology at the University of Pennsylvania and one of the leaders of the multicenter trial.

That should be good news for Avastin, the much cheaper of the two drugs and one that is already widely used to treat wet macular degeneration even though it does not have FDA approval for that use.

It's not such good news for Avastin's maker, San Francisco-based Genentech, because Genentech also makes Lucentis, a very similar drug. Lucentis has FDA approval for use in macular degeneration, the leading cause of blindness among older Americans.

According to the study, Avastin, a cancer drug, costs $50 a dose while Lucentis costs $2,000. Over the course of a year in the study, Avastin cost to $385 from $595, depending on the treatment regimen. Lucentis cost $13,800 from $23,400.

In a written statement, Genentech, part of Roche Holding AG, said Thursday that it continues to believe that Lucentis is the "most appropriate" treatment for wet macular degeneration. It cited data from the new trial that suggest Lucentis is superior on some measures and said Lucentis had been approved specifically for use in the eye while "Avastin is not manufactured or approved for use in the eye. It was specifically designed and approved for the treatment of patients with certain forms of cancer."

"If it was me, I would want Lucentis in my eye," said Anthony Adamis, vice president, global head of ophthalmology for Genentech. He said the new study, and others, show more safety problems with Avastin.

Adamis said the company spent $1.2 billion developing Lucentis and has no plans to lower its price or seek FDA approval to use Avastin in macular degeneration. He said the company's money would be better spent developing new drugs for other vision problems.

Insurance generally covers both drugs, doctors said, although patients may have higher copayments with Lucentis.

The study, published in the New England Journal of Medicine, was funded by the National Eye Institute, and found that the two drugs had equivalent impact on visual acuity when used for a year. The researchers will now look at whether differences develop over the following year.

The medications, which affect blood vessel growth and leakage, are injected directly into the eye.

The study also found that using the drugs as needed rather than every month was a viable treatment option.

More than a quarter of a million patients are treated for wet macular degeneration, which is more serious than the more common "dry" form, each year in the United States. Typically it develops in people in their 70s and 80s, Maguire said.

Macular degeneration is a disease that destroys sharp central vision.

Julia Haller, ophthalmologist-in-chief at Wills Eye Institute, which participated in the study, said the disease occurs when abnormal new blood vessels grow under the retina. The new vessels are fragile and permeable, and they leak fluids into the retina. The condition also causes scar tissue that kills photo receptors. "You end up with a big blind spot right dead center," she said.

Both Avastin (generic name: bevacizumab) and Lucentis (ranibizumab) are "miracle drugs," she said. Avastin, she said, is a "full-length antibody" to the vascular endothelial growth factor (VEGF), which stimulates blood vessels' growth. Lucentis is just a fragment of it.

Originally, she said, Genentech thought Avastin might help macular degeneration, but early tests in rabbits showed that a molecule of that size couldn't penetrate the retina. The company then developed Lucentis, a smaller molecule specifically designed to penetrate the retina. But then doctors started testing injections of tiny amounts of Avastin.

"It worked pretty darn well and it was cheap," Haller said. "Suddenly the company, totally blindsided, was in competition with itself."

Haller said she tended to use Lucentis when patients could afford it because it has been studied more and has FDA approval.

She said there were some signs in the new study that Lucentis may have a little more impact on the disease process, even if vision is the same. She's eager to see longer term data.

The study found no difference in adverse events expected with these drugs: death, heart attack, and stroke. However, the Avastin patients were more likely to have other serious systemic adverse events, primarily hospitalizations. That was surprising, Maguire said, because the problems were "spread across just about every system of the body" and have not been associated with cancer treatments where patients get 500 times as much drug per treatment.

"The lack of specificity makes you wonder about whether or not this is a true effect," she said.

A study from Johns Hopkins University scheduled to be presented next week at the Association for Research in Vision and Ophthalmology annual meeting also found more adverse events with Avastin. An abstract of that study, which was funded by Genentech and is posted on the association's website, found higher rates of death and bleeding strokes in macular degeneration patients treated with Avastin than Lucentis. That study examined Medicare data.

Daniel Martin, chair of the National Eye Institute trial and of the Cleveland Clinic Cole Eye Institute, said the Hopkins study had not been peer reviewed and was "inherently limited" and not comparable to his group's work.

While some patients are fine after just a few injections, many people need to keep taking the drugs.

Arlene McDermott, 75, a retired pediatric nurse in Swarthmore, is one of the latter. She said she has had 18 injections of Lucentis and about 24 of Avastin since she was diagnosed with macular degeneration five years ago. She now takes Avastin.

"It's the same scenario. I get the injection and it helps and after about a month, I start to see little changes again," she said. Her primary symptom is that straight lines start to look crooked.

For a woman whose primary forms of recreation are reading and watching movies, the drugs have been a godsend. She said she didn't know what she'd do if she couldn't see. "I just feel life would be so boring I don't know if I would even want to live," she said. "I just don't even like to think about it."


Contact staff writer Stacey Burling at 215-854-4944 or sburling@phillynews.com.

 

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