There is a new implant available to us in the United States for treatment of macular swelling (edema). The implant, Ozurdex®, is a product of Allergan Pharmaceuticals and received FDA approval in June 2009 for treatment of macular edema caused by retinal vascular occlusions. Ozurdex® is now available for your doctor to use when indicated.
What does Ozurdex have to do with diabetic macular edema? Macular edema can be caused by many diseases including vein occlusions, wet macular degeneration and diabetic retinopathy. Allergan Pharmaceuticals has launched its new product, Ozurdex®, for treatment of macular edema, but due to vascular occlusions. That is the official, FDA (Food and Drug Administration), indication for using Ozurdex®. Doctors, however, may legitimately choose to use a medicine for reasons other than the FDA approved indication. These are called “off-label” uses of medications.
What is Ozurdex®? Ozurdex is a novel sustained release drug delivery system that releases a steroid, dexamethasone, for an extended period of 4-6 months, then dissolves safely within the eye. Dexamethasone has been used for decades in medicine, that is, it is a well known, well studied medicine. It will be delivered into the eye as an injection, whereby a small, tiny pellet will be injected, release its medicine and then absorb.
What we know so far. Over the past few months, I have written several posts on the treatment of diabetic macular edema. Widely used treatments for diabetic macular edema include Avastin®, Lucentis®, Macugen® and intravitreal injections of steroids. Avastin® is FDA approved for colon and breast cancer, Lucentis® and Macugen® are FDA approved for treatment of wet macular degeneration and intravitreal steroids are not FDA approved for the eye at all. They are; however, standard of care. Standard of care is the care that another, reasonable, prudent doctor (in this case) would prescribe given similar situations and circumstances.
For the past 10 years or so, retina physicians have been injecting eyes with macular edema, with triamcinolone acetonide (aka Kenalog®) as an alternative to laser photocoagulation. The mainstay of treatment for diabetic macular edema has been laser treatment. Kenalog® has been a useful in treating those eyes where laser does not work.
What I project. This is not rocket science. As its cousin, Kenalog®, has been found to be useful for treating diabetic macular edema, so, too, will Ozurdex® find an “off-label” use for treating diabetic macular edema. It is not a huge leap to understand that if a short acting eye injection, such as Kenalog®, is effective in treating diabetic macular edema; a long acting system releasing its cargo over months will be found to be even more useful.
The point is that Ozurdex® may be very useful for patients with diabetic macular edema, too. It may be a huge improvement in current therapy. My guess is that within a year, patients will be offe