Two of the most commonly used treatments for neovascular age-related macular degeneration, ranibizumab, approved by FDA in 2006, and the other commonly used 'off-label', bevacizumab, resulted in similar improvements in visual acuity, according to results of a new trial.
Two of the most commonly used treatments for neovascular age-related macular degeneration (AMD), ranibizumab (Lucentis, Genentech), approved in 2006 by FDA, and the other commonly used 'off-label,' bevacizumab (Avastin, Genentech), resulted in similar improvements in visual acuity, according to a new randomized controlled trial published online in the New England Journal of Medicine.
AMD is the leading cause of legal blindness in people aged 65 and older. There are 2 forms of AMD, wet (also referred to as neovascular) and dry. While all cases begin as the dry form, 10% to 15% will progress to the wet form, which can result in severe central vision loss. It is estimated that more than 1.7 million Americans suffer from neovascular AMD.
In this most recent clinical trial, researchers randomly assigned 1,208 patients with neovascular AMD to receive intravitreal injections of ranibizumab 0.50 mg or bevacizumab 1.25 mg on either a monthly schedule (considered standard-of-care) or on an as needed basis with monthly evaluation.
Due to the finding of equivalency between the 2 agents, the researchers suggested that cost be an important consideration in choosing an agent.
"A single dose of ranibizumab costs 40 times as much as a single dose of bevacizumab," noted the researchers. They continued, "This cost differential has important economic implications when extrapolated to the more than 250,000 patients who are treated for neovascular AMD annually in the United States."
The average per patient cost of a drug in the entire 1 year of the trial was $23,400 for ranibizumab-monthly, $13,800 for ranibizumab-as-needed, $595 for bevacizumab-monthly, and $385 for bevacizumab-as-needed.
In regard to the comparative safety of the 2 agents, similar rates of death, myocardial infarction, and stroke were seen (P>.20 for all). Bevacizumab was, however, associated with a high incidence of serious systemic adverse events (24.1% vs 19.0%; relative risk, 1.29; 95% CI, 1.01–1.66).
The researchers cautioned readers that these differences in serious systemic adverse event rates could be attributable to chance or imbalances in baseline health status, and not necessarily a true difference in risk.
"Resolving this issue will require many more patients than were available for this study," stressed the researchers.
This trial, dubbed 'Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) was funded by the National Eye Institute of the National Institutes of Health. Both ranibizumab and bevacizumab are manufactured by Genentech.