On September 21, the U.S. Department of Veterans Affairs (VA) declared that it would no longer permit intravitreal injections of Avastin (bevacizumab, Roche/Genentech) for the treatment of any ophthalmic conditions, according to a report from Reuters. This announcement comes on the heels of several recent accounts of significant infection-related complications following intravitreal Avastin injections in Nashville, Tenn., Los Angeles and Miami (see “
Growing Reports of Bacteria-Tainted Avastin,” September 2011).
“The Department of Veterans Affairs has ceased ophthalmologic use of Avastin pending the results of an ongoing investigation and will advise its physicians to consider alternate therapies,” wrote VA representatives in an e-mail correspondence. “Once the investigation is complete, the VA will reassess how Avastin and similar therapies may be made available for ophthalmologic use and will issue further guidance.”
Avastin is commonly used off label to treat several sight-threatening retinal conditions, including age-related macular degeneration and diabetic macular edema. Another Roche/Genentech product, Lucentis (ranibizumab), is specifically indicated for the treatment of AMD. However, one dose of Lucentis costs about $2,000, compared to $50 for one dose of Avastin.
Because Avastin is not indicated for intraocular injection, compounding pharmacies must repackage the drug into single-dose vials. This process has the potential to yield bacterial contamination and subsequent infectious complications.
“There is a growing body of evidence that suggests injecting off-label Avastin into a person’s eye may pose greater risks than Lucentis,” Roche spokesman Terence Hurley told Reuters. “We do not believe that cost should be the only factor considered when choosing a medicine.”
Although multiple VA-affiliated optometrists declined to comment on the ramifications of this announcement, it appears likely that the use of Lucentis will increase dramatically at VAs.
Additionally, the VA’s decision may boost demand for another injectable drug, Eylea (aflibercept, Regeneron), which is expected to secure final FDA approval for the treatment of wet AMD in November.
“Regeneron’s Eylea stands to be well positioned in the market if it does get approved because it’s dosed half as frequently as Lucentis,” says Morningstar analyst Lauren Migliore.