Ozurdex, a sustained release drug delivery system, may soon be used to treat diabetic macular edema. The sustained release intravitreal implant has been tested, with favorable results, for possible use in treating the common retinal swelling caused by diabetes. Results were published recently in the March issue of the Archives of Ophthalmology.
Ozurdex was FDA approved for the treatment of retinal vein occlusions last year. It was the first sustained release drug delivery system for the eye. It releases dexamethasone, a well studied (i.e. old) steroid.
Diabetic macular edema is a common complication of diabetic retinopathy and is the most common cause of lost vision due to diabetes. The most common treatment for DME has been laser photocoagulation.
Over the past years, small anecdotal studies have implicated the favorable use of intraocular injections of either steroid or anti-VEGF medications as an alternative method for treating diabetic macular edema.
It is not uncommon for retinal specialists to turn to intraocular injections as a means to help control the retinal swelling as a first line of therapy or to augment the laser treatment.
The small study involved 171 patients and tested two strengths of Ozurdex along with placebo (i.e. nothing). Both strengths of the Ozurdex group showed improvement, and more importantly, improvement that was sustained for at least 6 months compared to the sham (placebo) group.
What Does This Mean? The results are expected. It is not surprising that a sustained release system shows improvement when the intraocular injections (shorter acting) showed improvement, too.
What is significant is the that the technology continues to move forward and that newer “treatments” continue to emerge based upon this sustained release technology.
Whether or not Ozurdex is going to be used for diabetic macular edema depends upon Medicare. If Medicare is going to reimburse (that is, pay) for Ozurdex in diabetes then docs may start using it routinely.
“Off-label” indications are really not the issue in this case, but the cost of Ozurdex is the issue. The cost of Ozurdex is about $1300.
If insurance companies do not reimburse Ozurdex, it is too expensive for patients to be willing to cover the expense out of their pocket.
Keep your eye out for news on Iluvien (pSivida/Alimera Sciences). Iluvien is expected to be presented to the FDA for approval for …treatment of diabetic macular edema. Iluvien is a sustained release drug delivery system that releases fluocinolone…a steroid.