Iluvien, an injectable drug delivery system for the treatment of diabetic retinopathy, gets closer to becoming FDA approved. Alimera Sciences announced this week that the FDA has given the investigational device “Priority Review” status. Priority Review status hastens the chances of full FDA endorsement from 10 months to 6 months.
Iluvien is a sustained drug delivery system that is injected into the eye, specifically into the vitreous. Similar to Ozurdex, Iluvien will release steroids into the eye, in this case, up to 3 years. Alimera Sciences anticipates that this drug delivery system will be approved for treating diabetic macular edema, a very common malady that affects those with diabetic retinopathy.
This approach is novel in that it will be the first pharmaceutical agent, or medicine, to be FDA approved for diabetic macular edema. To date, only laser treatment to the retina is approved.
On the other hand, retina specialists like myself, have been using intravitreal injections of Avastin or steroids for several years as an acceptable alternative to laser.
Ozurdex was released just over a year ago (summer 2009) for the treatment of retinal vein occlusions. Vein occlusions, another type of retinal disease, can cause significant loss of vision. I have had tremendous results using Ozurdex, especially for patients with branch retinal vein occlusions.
There are several other injectable systems under development, not just for diabetes, but for macular degeneration and other eye diseases as well.
What Does This Mean? This is significant news in several ways. First, there is a new therapy emerging for the treatment of the most common complication of diabetic retinopathy. This is a boon for physicians like myself who are tiring of the limits of laser photocoagulation. This system has the promise of making visual improvements not possible with laser.
There is a revolution just beginning in the management of eye disease. These injectable drug delivery systems will forever change our ability to treat, not just retinal disease, but eye disease overall.