- In a head-to-head diabetic macular edema study, comparing Regeneron's Eylea (aflibercept) and Roche/Genentech's Lucentis (ranibizumab) and Avastin (bevacizumab), Eylea improved vision more than the latter drugs.
- The study, which was sponsored by the National Institutes of Health (NIH), included 660 patients with diabetic macular edema and also vision of 20/50 or worse.
- Lucentis received an approval for diabetic macular edema in summer 2012, whereas Eylea received an approval in summer 2014. Lucentis also recently nabbed its fourth FDA approval earlier this month.
Generally, "gold-standard" trials are defined as randomized, double-blind, placebo-controlled trials. However, well-designed head-to-head studies would be the real gold standard—if only they were more common. This study, which was recently published in the New England Journal of Medicine, is important for its clinical implications, but also because of the underlying cost controversy.
In the doses used for the study, the per-injection treatment costs were $1,960 for Eylea; $1,200 for Lucentis; and $70 for Avastin. Avastin is cheaper, because it is used for cancer treatment in substantially larger doses, but repackaged into smaller doses for ophthalmologic purposes. While many physicians have been using Avastin off-label for ophthalmologic purposes, Genentech has long made the argument that Avastin is not indicated for this use and also that the compounding process used to create the appropriate doses is potentially dangerous.
Though cost continues to be a major concern, both Regeneron and Genentech are negotiating with payers and offering rebates and other financial incentives for their products.