20 Sep Generic ‘Avastin’ May Not Be Suitable For Eye Injections

MedicalResearch.com Interview with:
Szilárd Kiss, MD
Director of Clinical Research
Director of Compliance  Associate Professor of Ophthalmology
Weill Cornell Medical College NewYork-Presbyterian Hospital
New York, New York 10021

Medical Research: What is the background for your study?

Dr. Kiss: There has been a good deal of publicity about bevacizumab (Avastin; a Genetech/Roche antibody originally developed for treatment of cancer but now used widely to treat macular degeneration and diabetic retinopathy) being prepared by (mostly unregulated) compounding pharmacies for injection into the eye, and being associated with pathogen contamination.

Medical Research: What are the main findings of this report?

Dr. Kiss: In our paper, we assessed 21 samples of bevacizumab from 11 compounding pharmacies and found significant differences in the concentration of the antibody (mostly lower) than what is stated on the label from the compounding pharmacy compared to the primary sample of the drug from Genentech.

Moreover, we found large particulate aggregates in some of our samples from the compounding pharmacies. These findings have important efficacy and safety implications for our patients (as well as physicians who use bevacizumab in this off-label intraocular injection route).

Medical Research: What should clinicians and patients take away from this study?

Dr. Kiss: As more and more payers (e.g. insurers) push for the increasing use of compounded bevacizumab over other more expensive treatments for age-related macular degeneration and diabetic retinopathy (such as ranibizumab or aflibercept, both of which were developed and are manufactured specifically for intraocular use), we need to ensure the utmost safety and efficacy for all medications injected into the eye.

Our study casts doubt on the trustworthiness of the bevacizumab currently being compounded for intraocular use by mostly unregulated pharmacies nationwide.

Citation:

Last Updated on September 20, 2014 by Marie Benz MD FAAD