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(Bloomberg) -- Regeneron Pharmaceuticals Inc.’s injection Eylea helped patients with severe eye disease caused by diabetes more than two Roche Holding AG medicines in the first head-to- head study of the drugs.
The finding may lead to doctors shifting more patients with diabetic macular edema to more-expensive Eylea, a boost for Regeneron since the drug generates about two-thirds of the company’s sales. Eylea performed significantly better than the Roche drugs in people with moderate to severe vision loss, making it the preferred choice, said Daniel Martin, chairman of the Cleveland Clinic’s Cole Eye Institute.
“This study, more than any study that’s come before, will define how we treat patients,” Martin said in a telephone interview. The research was sponsored by the National Institutes of Health and published in the New England Journal of Medicine today.
Eylea offered more benefit than the Roche drugs on patients with eyesight equal to or worse than 20/50, meaning they can see as well at 20 feet away as a person with perfect vision can at 50 feet. Roche’s Avastin and Lucentis performed similarly to the Regeneron drug in participants with 20/40 vision or better, according to the study of 660 people.
Since outcomes were the same for the patients with mild vision loss, they should receive Roche’s Avastin, which at $50 a vial is cheaper than Lucentis’s $1,200 per dose, said Martin, who wrote an editorial accompanying the study today. Eylea, with a price tag of $1,950, should be the first-line therapy for the 25 percent of patients with worse eyesight, Martin said.
Eylea, first approved for age-related vision loss in 2011, was cleared by U.S. regulators last year for diabetic macular edema, a complication suffered by diabetes patients. Fluid from blood vessels leaks into the retina and causes swelling, leading to vision loss and blindness. It affects about 750,000 people in the U.S., according to today’s study.
U.S. sales of Eylea surged 23 percent in 2014 to $1.74 billion from a year earlier, Regeneron said this month. The Tarrytown, New York-based company forecasts the sales will grow 25 percent to 30 percent this year. Bayer AG sells the medicine outside the U.S.
Lucentis, cleared for the eye complication in 2012, generated $1.86 billion for Basel, Switzerland-based Roche last year. The drug is already losing sales to Avastin, a cancer drug from the company that isn’t approved for the eye disease but works in a similar way by blocking a protein critical to the formation of blood vessels.
The study’s finding that Eylea worked better than Lucentis or Avastin for patients with worse vision is “not something we’ve seen before,” said Jason Ehrlich, group medical director of ophthalmology at Roche’s Genentech unit. “We want to learn more about those patients and those particular results before we’d be able to really say, is this a truth, or is this a finding that hasn’t been replicated yet.”
Frederick Ferris, the clinical director of the NIH’s National Eye Institute and an author of the study, defended the results, saying, “This was a well-done study, and the differences are pretty large differences, relatively speaking.”
For patients with 20/50 vision or worse, the average visual-acuity letter score improvement was 18.9 with Eylea, 14.2 with Lucentis, and 11.8 with Avastin, according to the study. This means Eylea patients gained an additional full line or more on an eye chart, according to Regeneron.
George Yancopoulos, Regeneron’s chief scientific officer, said that doctors should also pay attention to the study’s finding that Eylea reduced swelling more than the other treatments.
“If cost was not an issue, I would certainly prefer to give, even in the population with minimal vision loss, the drug that corrects the anatomy,” Yancopoulos said.
Eylea’s higher price may indeed influence care, NIH’s Ferris said. “A lot of people may continue to start with Avastin regardless, because of the costs.”
Regeneron doesn’t give physicians rebates and has assistance programs to help patients pay for the drug, said Yancopoulos. Genentech spokesman Terence Hurley said rebates and discounts, as well as patient support services, are available for Lucentis.
“We believe that all financial incentives and logistic barriers to providing the least-expensive drug, among drugs equivalent in safety and efficacy, should be eliminated so patients may fully benefit from the results” of the trial, said Martin in the editorial.
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