(Corrects measurement in second paragraph in story published April 28.)
Roche Holding AG (ROG)’s Avastin was as effective as the company’s more costly Lucentis for treating the most common cause of blindness in the elderly, according to a study published in the New England Journal of Medicine.
Patients given Avastin, a cancer drug not approved for the disease, had a similar improvement in vision as those given Lucentis, which was developed for the condition known as wet age-related macular degeneration, or AMD. Vision improved by 8 letters on an eye chart for patients given Avastin, compared with 8.5 letters for those on Lucentis, the study found.
The study, dubbed CATT, validates an approach doctors crafted five years ago when they had few ways to treat the condition caused when blood vessels in the eye leak and damage the macula. Avastin will continue to lead the market for macular degeneration, researchers said, potentially shrinking the space for costly brand name drugs like Lucentis and an experimental therapy from Regeneron Pharmaceuticals Inc. (REGN) and Bayer AG. (BAYN)
“The CATT results, together with the totality of global experience, support the use of either” Avastin or Lucentis for the treatment of macular degeneration, said Philip Rosenfeld, a professor of ophthalmology at the Bascom Palmer Eye Institute at the University of Miami. “Health-care providers and payers worldwide will now have to justify the cost of using ranibizumab,” or Lucentis, he wrote in an editorial.
Forty Times as Expensive
A single dose of Lucentis costs 40 times as much as a dose of Avastin, researchers led by Daniel Martin, chair of the Cleveland Clinic Cole Eye Institute, said in the study. Lucentis given every month cost $23,400, compared with $595 for Avastin, which is used in about 60 percent of the cases. A separate arm of the study suggested the drugs may be given less frequently without a significant reduction in benefit.
The cost difference has important economic implications when applied to the 250,000 Americans treated for macular degeneration annually, the researchers said.
Patients getting injections only when needed, such as when there were signs of fluid buildup or reduced vision, were able to eliminate about five shots a year. The difference in vision, losing about two letters on an eye chart, is about the same as having a smudge on your glasses or looking through them after they have slipped down your nose, said Paul A. Sieving, director of the National Eye Institute, in a press conference.
Doctors have primarily given their patients Avastin and treated them on an as-needed basis, said Martin, of the Cleveland Clinic. The results show the approach is appropriate, he said.
“This trial was conducted to determine the best drug for our patients and the optimal dosing frequency,” Martin said in a conference call. “It’s a choice we as clinicians make every single day.”
Regeneron fell $2.44, or 3.6 percent, to $64.61 at 4:15 p.m. in Nasdaq Stock Market trading. Shares of the Tarrytown, New York-based company have almost tripled in the past 12 months. Roche, based in Basel, Switzerland, rose 2 Swiss francs, or 1.5 percent, to 138.8 francs in Zurich. Bayer rose 1.18 euros, or 2 percent, to 58.78 euros. Novartis AG (NOVN), which sells Lucentis outside of the U.S., rose 0.5 Swiss francs, or 1 percent, to 51.4 francs.
Regeneron and Bayer’s drug, called VEGF Trap-Eye, showed a similar benefit for patients in clinical trials, though it’s given every other month, said Michael Aberman, Regeneron’s vice president of strategy, in a telephone interview. Patients treated as needed with Lucentis and Avastin still required monthly doctor visits, and the improvement with less frequent Avastin was not as good, he said.
“We still believe our VEGF Trap-Eye, given every two months, offers a potential advantage if it’s approved, compared to other therapies,” he said. “We’d like for patients and physicians to have a choice that includes a unique molecule with more convenient dosing.”
Since Avastin works by choking off blood vessels, doctors injected tiny amounts of the drug into the eye. While results were dramatic, there were no studies proving the approach was safe or effective. Still, it is the most common drug used to treat the condition, doctors said.
“Ophthalmologists and retinal specialists seem to be very price-sensitive,” said Ziad Bakri, an analyst with Cowen & Co. in New York. “A lot of them outwardly express discontent toward Genentech,” the South San Francisco, California-based Roche unit that developed Lucentis and Avastin, “and some of its reimbursement policies and pricing decisions.”
The study released today of 1,208 patients funded by the National Eye Institute provides assurance that Avastin, also known by its chemical name bevacizumab, is effective. Almost one in four patients given Avastin suffered a serious side effect in the first year, mainly hospitalization, compared with 20 percent of those given Lucentis. There were no differences in deaths, heart attacks and strokes.
The difference in hospitalizations and other serious adverse events is key, said Anthony Adamis, global head of ophthalmology at Genentech. If the results are borne out, that would mean an additional hospitalization for every 25 patients treated with Avastin, he said in a telephone interview.
“That is not trivial,” he said, pointing out that many of the patients are elderly. “We designed Lucentis to be different from Avastin specifically to avoid these sorts of side effects. It’s cleared much more quickly from the blood stream,” potentially reducing the risks, he said.
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