The most widely used drug in American retina clinics has been injected into eyes for about twenty years without an FDA-approved formulation for that purpose. That changed on July 24, when the Food and Drug Administration approved Lytenava, an ophthalmic version of bevacizumab, for neovascular age-related macular degeneration.
The distinction sounds technical. It is not. Bevacizumab was approved for cancer and supplied as a large vial for intravenous infusion. To use it in the eye, compounding pharmacies have been dividing those vials into small syringes. That process has no FDA-reviewed standard for sterility, potency, or labeling written specifically for injection into the eye, and sterile compounding carries real risk when it is done poorly.
