Questions & Answers

I read with interest your article on age-related macular degeneration (AMD), published in the June 2015 issue of Worst Pills. I have a question: Why did you not mention anything about geographic atrophy caused by the injections to control wet macular degeneration?

You are correct: We did not include discussion of this potential side effect of injections for wet AMD,[1] and we’ll tell you why. Geographic atrophy, or advanced "dry AMD," is a condition that can lead to vision loss. But the decline in vision with this condition tends to be slower than with wet AMD.[2]

Geographic atrophy was documented as a potential side effect of frequent injections for wet AMD in a large, publicly funded, two-year randomized clinical trial published in 2012.[3] That trial compared two different injection schedules for each of two drugs used to treat wet AMD: ranibizumab (LUCENTIS) and bevacizumab (AVASTIN). (Bevacizumab is not approved by the Food and Drug Administration for treating this eye disease, making this an off-label use.) The drugs were injected either monthly for two years or monthly for one year followed by injections as-needed for one year (in other words, only if signs or symptoms of wet AMD returned). The results showed that the risk of geographic atrophy was slightly higher among subjects receiving monthly injections for the full two years than among those who were switched to as-needed injections after one year (regardless of which drug they received).[4]

In spite of this risk, we do not recommend that Worst Pills, Best Pills News readers reduce their injections in attempts to avoid geographic atrophy. The same study that demonstrated that monthly injections for two years lead to higher rates of dry AMD also showed that these continuous monthly injections also led to better vision than as-needed injections. The better results are most likely due to the vision gains associated with continued successful treatment of wet AMD, which outweighed any vision losses associated with geographic atrophy risk.

I read your article[5] on wet AMD treatment, published in the June 2015 issue of Worst Pills, and want to share a different view. Research has shown that bevacizumab is just as effective as ranibizumab, and is also much less costly for Medicare. After learning this, I chose bevacizumab for my own treatment, with excellent results! Why not recommend this product?

As we described in our article, a large, publicly funded, randomized clinical trial demonstrated bevacizumab’s effectiveness in treating wet AMD. Bevacizumab (AVASTIN) is also much less expensive than the two FDA- approved treatments for this condition: ranibizumab (LUCENTIS) and aflibercept (EYLEA).

Nevertheless, we cannot recommend that patients use off-label bevacizumab for wet AMD treatment at this time. There are risks involved with bevacizumab use for wet AMD. The version of this drug that is FDA-approved for treating cancer is repackaged for AMD in facilities that are currently not well monitored by the FDA and state agencies. These circumstances introduce the potential for this sterile product to become contaminated.

Between 2010 and 2013 there were at least three large-scale outbreaks of infection linked to contaminated bevacizumab.[6] The largest of these led to loss of vision in 11 patients. An additional error in a hospital pharmacy in 2011 led to brain damage or vision loss for five patients after bortezomib (VELCADE), a cancer treatment, was accidentally repackaged and labeled as bevacizumab for eye injection.

Until oversight of bevacizumab repackaging improves, we will continue to recommend that consumers avoid using this product to treat wet AMD.

References

[1] Injections for age-related macular degeneration. Worst Pills, Best Pills News. June 2015. /newsletters/view/971. Accessed August 17, 2015.

[2] National Eye Institute (NEI). Facts about age-related macular degeneration. https://www.nei.nih.gov/health/maculardegen/armd_facts. Accessed April 1, 2014.

[3] Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group, Martin DF, Maguire MG, Fine SL, et al. Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: Two-year results. Ophthalmology. 2012;119:1388-1198.

[4] Ibid.

[5] Injections for age-related macular degeneration. Worst Pills, Best Pills News. June 2015. /newsletters/view/971. Accessed August 17, 2015.

[6] Public Citizen. Comments to Stephen Ostroff and Janet Woodcock on the mixing, diluting, or repackaging biological products outside the scope of an approved biologics licensing application; draft guidance for industry (Docket No. FDA-2014-D-1525). May 20, 2015. http://www.citizen.org/documents/2259b.pdf. Accessed June 16, 2015.