THIS STORY HAS BEEN FORMATTED FOR EASY PRINTING

$50 eye drug found equal to $2,000 dose

Study may alter patient choices

By Deborah Kotz
Globe Staff / April 29, 2011

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An expensive eye injection that’s approved to treat macular degeneration — the most common cause of age-related blindness — works no better than a much cheaper drug at preventing vision loss. That’s the finding of a long-awaited study published online yesterday by the New England Journal of Medicine.

The study, involving more than 1,200 patients with the “wet’’ form of macular degeneration, found no difference between those who were randomly treated for one year with the more expensive drug Lucentis — which costs about $2,000 a dose — and the cheaper drug Avastin, which costs $50.

“Lucentis and Avastin were equivalent for visual acuity,’’ said study leader Dr. Daniel Martin, chair of ophthalmology at the Cleveland Clinic Cole Eye Institute during a press conference. “When we looked at the number of letters gained or lost on an eye chart, the lost or gained lines of vision, the two drugs are virtually identical.’’

For about five years, doctors have been treating most macular degeneration patients “off-label’’ with Avastin (bevacizumab), which is primarily a cancer treatment, since it’s chemically similar to Lucentis (ranibizumab). (They use a fraction of the dose given cancer patients.) But there was always uncertainty as to whether it was just as safe and effective. Experts say the new study indicates that it is.

The study results “support the use’’ of either Avastin or Lucentis for wet macular degeneration, writes Dr. Philip J. Rosenfeld, a professor of ophthalmology at the Bascom Palmer Eye Institute in an editorial that accompanied the study. “Health care providers and payers worldwide will now have to justify the cost of using ranibizumab.’’

Genentech, which manufactures both drugs, begs to differ. The company has no plans to seek approval from the Food and Drug Administration to market Avastin for the treatment of macular degeneration.

“We still believe Lucentis is the best treatment for macular degeneration,’’ said Dr. Anthony Adamis, vice president and global head of ophthalmology at Genentech. “It was designed for use in the eye and clears the bloodstream in a couple of hours; Avastin, intended for cancer patients, hangs around for 20 days or more,’’ which raises the likelihood of greater side effects.

He adds that the study found a slightly higher rate of side effects that, while not statistically significant, could prove to be an issue in larger trials designed to measure safety differences. One such trial is underway, with results expected next week.

What’s more, Adamis said, Lucentis might still prove to have better long-term efficacy since it was found to be superior to Avastin at clearing fluid from the retina, which is often a cause of vision loss.

The researchers conceded they would have more answers on that after they continue to collect data over the next year. “We’re really not going to know whether the small difference we saw will have some sort of visual acuity effects until then,’’ Martin said.

Adamis said the price differential between Avastin and Lucentis could be explained by the dosing. “Doctors order it [Avastin] in a single vial and then split it up into fraction-strength doses for use in the eye.’’ Genentech has no plans to raise the price of Avastin.

Dr. Ivana Kim, a retina specialist at the Massachusetts Eye and Ear Infirmary who served on the research team for the new study, said the results would change the way she discusses both treatment options with patients. While most have chosen Lucentis over Avastin — preferring an FDA-approved drug — she said she would now explain that both choices are fine. “Before I was uncertain, but now I can tell them that they don’t need to compromise in terms of efficacy; that either is fine.’’

Deborah Kotz can be reached at dkotz@globe.com.