Note on off-label use of Avastin

Bevacizumab, sold under the trade name Avastin, is a recombinant humanized monoclonal
antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A).
Bevacizumab was approved by the U.S. Food and Drug Administration (FDA) for certain
metastatic cancers only.

Bevacizumab has recently been used by ophthalmologists in an off-label use as an

intravitreal agent in the treatment of proliferative (neovascular) eye diseases, particularly for
choroidal neovascular membrane (CNV) in AMD. Although not currently approved by the FDA
for such use, the injection of 1.25-2.5 mg of bevacizumab into the vitreous cavity has been
performed without significant intraocular toxicity. Many retina specialists have noted impressive
results in the setting of CNV, proliferative diabetic retinopathy, neovascular glaucoma, diabetic
macular edema, retinopathy.
Apart from Avastin, drug named Lucentis (Ranibizumab) is available in the market which is
officially approved by FDA for ophthalmic use, but it is nearly 50 times more costlier than Avastin
and this is the driving force promoting use of Avastin in Opthamology.
Bevacizumab was being used as off-label treatment in ophthalmology since year 2005
across the world.
In the month of January-2016, in C.H. Nagri Municipal Eye Hospital in Ahmedabad city, 15
patients underwent surgery last week and reported swelling and pain in their eyes following
usage of Avastin. Following this incidence on 21-01-2016, DCG(I) issued direction to stop the
usage of this drug in ophthalmology and constituted an expert committee to examine the case.
Based on the recommendations of this expert committee and representations of the All India
Ophthalmology Society, on 11.03.2016 DCG(I) has withdrawn the alert notice issued by him on
21-01-2016.
The manufacturer of the Avastin (M/s Roche) has several times stated that they are not
promoting the use of Avastin in Ophthalmology in light of this incidence.