Wednesday, May 08, 2013

Editor’s blog: Significance of no statistical difference - See more at:

Seattle—As of Tuesday afternoon at this year's Association for Research in Vision and Ophthalmology (ARVO) meeting, all of the head-to-head comparison studies involving the efficacy and the safety of ranibizumab (Lucentis) and bevacizumab (Avastin) are officially IN.
The final verdict (NO drumroll, please): bevacizumab and ranibizumab are statistically NO different in the treatment of neovascular age-related macular degeneration (AMD).

On Tuesday, the results of the Inhibition of VEGF in Age-related Choroidal Neovascularisation 2 (IVAN2) Study and the Groupe d’Evaluation Français Avastin versus Lucentis (GEFAL) Study, the French comparison study, were presented. The conclusion for both studies pretty much coincided with the results presented in the Comparison of AMD Treatment Trials (CATT), CATT2, and the original IVAN studies that were presented at previous ARVO meetings: That both drugs are basically equal (with some minor differences) in the treatment of AMD.
Hopefully, the debate between the use of both drugs is finally put to rest and ophthalmology can move forward (unless the French ophthalmic community decides to drag this on for another year with a GEFAL2). The foregone conclusion of these trials pretty much came to the same conclusion on most points that "there was no statistical difference between ranibizumab and bevacizumab."

Most of the ophthalmic community should be good with those conclusions. Even Genentech, the manufacturer of both drugs, has pretty much accepted these conclusions. The bevacizumab supporters have proven their point that their drug is just as good as the FDA-approved drug—at a fraction of the cost.
This is where a "statistical difference" can be found—the price. Ranibizumab costs about $2,000 an injection, while bevacizumab costs less than $100. That is a really big statistical difference, especially to a patient who has limited income or whose insurance may not be so generous to pay. To help patients get their treatments, physicians have that right to utilize that off-label option.

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