Monthly eye injections of the drug Lucentis can dramatically improve sight in people with the "wet" form of macular degeneration, the leading cause of blindness in the elderly, two studies showed on Wednesday.
But the findings, published in The New England Journal of Medicine, raise questions about cost. The wholesale price of just one treatment is $1,950 and there may be an alternative that costs just $17 to $50 instead.
That alternative, injections of the colon cancer drug bevacizumab, have not been rigorously tested. Both Lucentis, also known as ranibizumab, and its cheaper cousin, Avastin, are made by Genentech Inc.
In the first Lucentis study, 477 volunteers who received monthly injections over two years gained the ability to see one line of letters on a typical eye chart.
The 236 placebo recipients, meanwhile, lost more than two lines, according to the study led by Philip Rosenfeld of the University of Miami Miller School of Medicine.
In the second study, 280 people receiving Lucentis gained two lines of visual acuity after a year while two lines were typically lost for the 143 patients receiving an alternative treatment — a laser-activated drug designed to seal off the eye's abnormal blood vessels responsible for the blindness.
Although no volunteers in the second study had 20/20 vision when tests began, after a year more than 6 percent of Lucentis recipients developed normal vision, regardless of the dose. The rate was less than 1 percent with the other treatment, said the team led by David Brown of Methodist Hospital in Houston.
Both tests were financed by California-based Genentech and Swiss drug maker Novartis, which is marketing the drug outside the United States.
Head-to-head comparisons needed
Robert Steinbrook of the New England Journal of Medicine said in an analysis of pricing issues that a head-to-head comparison was needed between Lucentis and the cheaper alternative bevacizumab, along with tests to determine if less-frequent injections would be as effective.
Lots of money is at stake: Injections may be required for life and about 15,500 new cases of the condition, also known as neovascular macular degeneration, are diagnosed in the United States each year, usually in people over 64.
"Though data from controlled trials are lacking, bevacizumab appears to be safe and effective in the short term. And ophthalmologists frequently use medications off-label," said Steinbrook.
"The good news for patients is that there are two new medications for neovascular age-related macular degeneration, both of which appear to work better than the alternatives. But since they have never been directly compared, physicians can only speculate about which drug is superior," he said.
"The price difference is too big to ignore."
Insurance reduces patient cost
Genentech estimates about 81 percent of patients have enough insurance to reduce the out-of-pocket copayment for Lucentis to $50 or less per treatment.
The Lucentis molecule is a third the size of that in bevacizumab, which may make it more effective at controlling the growth of sight-damaging blood vessels.
But bevacizumab's larger size may allow it to persist in the eye longer, requiring fewer injections.