For about twenty years, the most commonly used drug for wet age-related macular degeneration has reached retina clinics by an unusual route. A pharmacy buys a vial of bevacizumab labeled and manufactured as an intravenous cancer infusion, draws it into syringes under sterile conditions, and ships those syringes to ophthalmologists, who inject a fraction of a milliliter into a patient's eye. That practice is legal, widespread, supported by clinical evidence, and has never involved a product the FDA approved for use in the eye.
That changed last week. The FDA approved Lytenava (bevacizumab-vikg) from Outlook Therapeutics for neovascular AMD, the first ophthalmic formulation of bevacizumab the agency has ever cleared in the United States.