Iluvien, a sustained release drug-delivery system for the treatment of diabetic macular edema, may be getting closer to possible FDA approval. The parent company, Alimera Sciences has resubmitted additional safety and efficacy data as requested by the FDA last year. The FDA requested that they be given data extending for a 3 year period instead of the 2 years in the new drug application.
Iluvien may be an effective new treatment for diabetic macular edema. In theory, patients that require treatment for this common complication of diabetic retinopathy may receive an injection of Iluvien. Iluvien will then release a steroid over several months and the company is trying to prove that it provides a benefit to the patients, in this case, the vision improves.
Such safety and efficacy data were presented recently to the public at a large ophthalmic meeting in FL last month. The company has also submitted this data to the FDA (Food and Drug Administration).
In short, the company performed two large clinical trials, the so-called FAME study showed that about 33% of patients receiving the implant noted an improvement in vision. Of significance is that this improvement, according to the company, was present after 3 years.
Last year, the FDA also asked for a review of the manufacturing process of Iluvien, but I am not aware of any specific elements that were made public. These, too, have been addressed.
What Does This Mean?
About a year ago, Alimera Sciences submitted the new drug application (NDA) for it’s proprietary intraocular drug delivery system for the treatment of diabetic macular edema (DME).
The NDA is the last step to acheiving FDA approval for a new drug.
Last December, the FDA failed to approve the NDA, but, instead requested more data about the efficacy (how well a drug works) of Iluvien. This was provided this Spring.
So…we continue to wait. There should be some decision made this Fall, but my guess will be that it is favorable.
If you remember, Ozurdex, the first sustained release intraocular drug delivery system was approved for treatment of retinal edema caused by retinal vascular diseases.
It may be that a second such device may be shortly approved for the treatment of diabetic retinopathy. While this further endorsed the sustained release technology, it will be a breakthrough that allows significantly more people to be helped that presently have few options.