Iluvien™, a new drug for the treatment of diabetic macular edema, draws one step closer to FDA approval. Alimera Sciences/pSivida announced that Iluvien showed favorable results in two Phase 3 clinical trials. The company has announced they will file for a New Drug Application (NDA) based on the favorable results.
Iluvien releases fluocinolone acetonide, a well studied steroid, after injection into the eye. Intraocular injections have become a popular method for treating a variety of retinal disorders including macular degeneration and diabetic macular edema. The injections are performed in an office setting.
The drug will be released for 24-36 months. The delivery system is based upon the Medidur™ delivery platform. Medidur is the proprietary delivery system that, when coupled with fluocinolone acetonide, is dubbed Iluvien. The platform does not dissolve and remains inside the eye.
Basically, the steroid implant improved vision in almost twice as many patients as those treated with placebo. In addition, 75% of patients required only one application of the device.
The last step for Iluvien is now to gain the coveted FDA approval. The last step following Phase 3 clinical trials is for Alimera Sciences (licensee of Iluvien from manufacturer pSivida) to file a New Drug Application. It expects to file by the end of the 2nd quarter of this year.
Ozurdex™ received FDA approval last summer for the treatment of retinal vein occlusions; branch retinal vein occlusion and central retinal vein occlusion. Like Iluvien, Ozurdex releases steroid over a period of months. The major difference between the two technologies is the specific type of steroid (Ozurdex releases dexamethasone), duration of release and the FDA guidelines for use.
Iluvien is most likely going to be the first drug FDA approved for the treatment of diabetic macular edema, whereas, Ozurdex is the first for treatment of retinal vein occlusions.
What Does This Mean? One year ago, sustained release drug delivery did not technically exist in ophthalmology. By this summer, there may be a second delivery system for treatment of retinal disease. Clearly the tide is turning in terms of the way we can treat eye disease.
It is quite likely that other drugs will follow…we are anxiously awaiting the first sustained release system for macular degeneration.
I believe that sustained release technology will evolve to treat other eye diseases as well, not just retinal disease. For instance, what if there were no longer eye drops needed for glaucoma?