Iluvien gets closer to FDA approval for treatment of diabetic macular edema. Earlier this week, I wrote about emerging treatments for diabetic retinopathy. Of the group, Iluvien is now the most likely to be available.
Alimera Sciences has filed for NDA (New Drug Application) for Iluvien. In March, the company announced the favorable results in their clinical trials for the FDA. The NDA is the last step for FDA approval.
Iluvien is a sustained release drug delivery system. Similar to Ozurdex, the delivery system will release steroid after injection into the eye. (Ozurdex is presently FDA approved for retinal vein occlusions, not diabetic retinopathy. The makers of Ozurdex are hopeful that it may be used for diabetes.)
The steroid released by Iluvien, fluocinolone, will last for 24 months after injection. The vehicle will remain in the eye after the drug is released.
The present treatment for diabetic macular edema involves laser treatment, anti-VEGF injections and/or steroid injections. The laser treatment has limited applications, that is, it can’t be used in all patients and also doesn’t work as well as any of the injections.
The injections, on the other hand, don’t last long and need to be repeated.
Iluvien may obviate the need for repeated treatments and offer significant improvement in vision compared to the standard laser therapy. With fewer injections, there is less chance of infection.
What Does This Mean? Ozurdex was FDA approved about one year ago. The significance of Iluvien’s NDA is the validation of the advantages of intraocular sustained release drug systems.
All emerging treatments for diabetic macular edema involve injections. All seem to offer superior treatment compared to the standard of care, laser photocoagulation. A sustained release system for diabetic retinopathy will change the way we treat this very common eye disease.
The introduction of Iluvien is estimated to be towards the end of the year according to this week’s press release.
I can’t wait.