Study: Off-Label Bevacizumab Is "Equivalent" to Ranibizumab for Treatment of Neovascular AMD

Government research suggests $50-a-dose Avastin is safe alternative to $2,000-a-dose Lucentis.

Intravitreal injections with bevacizumab (at about $50 a dose) are just as safe and effective as injections with ranibizumab ($2,000 a dose) in treating neovascular age-related macular degeneration, according to the 1-year results of a government study comparing the molecularly similar drugs.

Despite the similar outcomes associated with them, there are 2 major differences between bevacizumab (brand name Avastin) and ranibizumab (Lucentis): The former is a cancer drug not FDA-approved for the treatment of "wet" age-related macular degeneration (AMD), while ranibizumab is designed and approved expressly for that purpose. And, of course, bevacizumab is 40 times less expensive.

Off-label use of the much-cheaper bevacizumab to treat neovasclar AMD is relatively common in the United States, according to Paul Sieving, MD, PhD, director of the National Eye Institute, which sponsored the multicenter, single-blind, noninferiority trial.

The study's 1-year results, published last month in the New England Journal of Medicine, show equivalent changes in visual acuity among patients injected monthly with bevacizumab (8.0 letters gained) and those injected monthly with ranibizumab (8.5 letters gained). Results were also comparable when patients were administered the drugs as needed: 5.9 letters gained in bevacizumab group vs. 6.8 letters gained in ranibizumab group.

The rates of death, myocardial infarction and stroke were similar in the 2 groups, but a higher proportion of bevacizumab patients (24.1%) had "serious systemic adverse events (primarily hospitalization)" compared to the ranibizumab group (19%). The researchers conclude that further study is needed to account for this difference in the rate of serious adverse events.

"Lucentis and Avastin were equivalent — in fact, virtually identical for visual acuity at all time points — when administered in the same dosing regimen," said lead author Daniel Martin, MD, of the Cleveland Clinic Cole Eye Institute, while reporting 2-year study data at the annual meeting of the Association for Research in Vision and Ophthalmology earlier this month. "I have seen nothing so far regarding adverse events that would concern me greatly, and I would probably start with Avastin," Dr. Martin continued when asked whether he'd recommend 1 drug over another for a family member suffering from AMD.

Genentech, the company that markets both drugs, maintains that they are "different medicines" and that the National Eye Institute study adds to "an emerging body of evidence from much larger analyses that suggest risk of systemic adverse events may be higher when injecting Avastin into a person's eye compared to Lucentis."