Retinal swelling can now be treated by either laser treatment or intravitreal injection. This is the first time we (doctors, that is) have an FDA approved alternative for the treatment of DME.
Laser treatment, the gold standard for DME, has been in use for about 30 years and has been the standard of care. Not all patients; however, are great candidates for laser treatment. Either their swelling doesn’t respond to laser treatment, or the areas of leakage can’t be treated without damaging the central vision.
Intravitreal injections are attractive because they treat the disease by a different mechanism.
The goal of successful treatment for DME is to decrease the amount of swelling. Laser treatment works by heating the areas of leakage and/or increasing absorption of the abnormal fluid.
Lucentis, and other anti-VEGF medications, are known to work by chemically stopping the leakage of the normal retinal blood vessels.
Due to the different mechanisms by which the treatments work, it is plausible that both Lucentis and laser treatments can be used to achieve success. While not usually applied at the same time, both injections and laser treatment are often used in combination over the course of treatment.
What Does This Mean?
Use of Lucentis for diabetic retinopathy is actually not new.
Retina specialists have been using Lucentis and Avastin (both are similar anti-VEGF medications) for several years to treat diabetic macular edema. Both have been FDA approved for the treatment of other diseases (macular degeneration and cancer, respectively) and have been used “off-label” for the treatment of macular edema.
Off-label use, that is, prescribing a drug for other than the FDA approved treatment is common practice. FDA approval is necessary for getting a drug to market, but once on the market, other uses may be determined.
While this approval does validate our “off-label” use of the drug, it now allows the manufacturer to market the drug as a treatment for diabetic retinopathy. Without FDA approval, a company can not advertise or recommend its use for anything other than the intended treatment.