|Published:||Apr 28, 2011 7:22 PM EDT|
|Updated:||Apr 28, 2011 4:22 PM EDT|
(AP) - A much cheaper drug has proved just as good as a $2,000 monthly shot to treat a common eye disorder that can lead to blindness, a long-awaited study has found.
The results are expected to lead many doctors and patients to turn away from the pricier Lucentis and instead use $50 shots of Avastin for an age-related condition called wet macular degeneration.
Vision improvement after one year was the same for those given monthly shots of Avastin or Lucentis, the 1,200-patient study found.
One concern: more serious adverse effects occurred among Avastin users. But they are not the type usually seen with these drugs, and only wider use and more study will tell whether one is safer than the other, eye experts said.
The results are a blow to Roche's Genentech unit, which sells both medicines. Avastin is a cancer drug that doctors have used for many years to treat the eye disease even though it is not approved for that purpose. Genetech later developed Lucentis for the eye disease, and it was approved in 2006. A company spokesman said Thursday that the company had no plans to seek approval to sell Avastin for eye use.
Yet the results are a boon for patients and insurers because nothing prevents them from using the cheaper Avastin, eye specialists said. Doctors who use it for the eye disease must get a pharmacist to prepare lower doses for injection rather than the intravenous way it's used for cancer.
"It's always good news for patients when there are more than one option for a condition. It's good news for the country. Now we have potential for significant savings at a time when the cost of health care is skyrocketing," said Dr. Paul Sternberg, chairman of the Vanderbilt Eye Institute.
He had no role in the study, which was led by Maureen Maguire at the University of Pennsylvania. Results were published online Thursday by the New England Journal of Medicine and will be presented at an eye research conference on Sunday.
Anyone wanting to use Lucentis now will have to justify its cost to insurers and policymakers, Dr. Philip Rosenfeld of Bascom Palmer Eye Institute at the University of Miami wrote in an editorial with the study. He has no ties to Genentech but has consulted for several other companies developing eye treatments.
More than 250,000 Americans are treated for macular degeneration each year, said Dr. Paul Sieving, director of the National Eye Institute, the federal agency that paid for the study. The disease occurs when abnormal blood vessel growth damages the part of the retina responsible for central vision, and the two drugs aim at a protein that spurs blood vessel growth.
The drugs are injected through the white part of the eye into the central cavity. Numbing drops are used and patients generally feel pressure more than pain, Sternberg explained.
"The first time you tell a patient they're going to have to receive one they are taken aback and apprehensive, but they are remarkably tolerated," he said of the shots.
In the study, patients were given one of four treatments: Avastin or Lucentis every four weeks, or Avastin or Lucentis on a variable schedule depending on response to the drug for one year.
Vision improvement was nearly identical for either drug given monthly, and no differences were seen in how many got substantially better or worse. Injecting the drugs less often, on an as-needed basis, revealed no differences between the drugs but produced less vision improvement than monthly dosing did.
About 24 percent of Avastin users and 19 percent of those on Lucentis had a serious side effect, mostly a need for hospitalization. The study is too small to clearly answer safety questions, and these differences require more study, researchers said.
A statement from a Genentech spokesman said that proving Avastin's benefit for the eye disease would take "substantial resources and years of clinical development," and that patients' best interests are better served by exploring new medicines.
Although Genentech sells both drugs, PDL BioPharma Inc. gets royalty payments on Lucentis, and Novartis AG has exclusive rights on it outside the U.S.