™Alimera Sciences’ “Iluvien®” moves closer to FDA approval for the treatment of diabetic macular edema. Iluvien is an extended release drug delivery system designed for direct intravitreal injection to the eye. Iluvien will release a steroid, fluocinolone acetonide, for up to 36 months to treat retinal swelling. The company has announced pivotal results in the ongoing FAME (Fluocinolone acetonide in diabetic macular edema) study. This is a phase 3 FDA clinical trial.
An earlier post covered Iluvien’s safety and efficacy in phase 2 trials for the treatment of diabetic macular edema.
Diabetic Macular Edema is the most common complication of diabetic retinopathy. The traditional laser for diabetic retinopathy has been usual treatment for about 30 years. I have written previously about the emergence of new treatments and new technologies to treat the diabetic macular edema. Intravitreal steroid injections, anti-VEGF and sustained release intraocular drug delivery systems are all the rage.
FDA Clinical Trials dictate how medicines are approved for treatment of disease in the U.S. I have always cautioned that you must consider a “treatment” only if it has already been FDA approved. Most of what is advertised as treatment is neither FDA approved nor even studied.
There are 4 different steps to passing the FDA requirements. There are 3 phases of clinical trials (sometimes an additional phase 4 is required) and the NDA (New Drug Application).
The phase 3 clinical trial (FAME) is almost complete. The study will proceed to 36 months. The early phase 3 findings indicate improvement in vision in about 25-30% of patients after the first 24 months of the study.
What Does This Mean? This is huge. It means that there is merit to what the company anticipates. Technically, phase III trials determine if the drug is useful and confirms safety.
New Drug Application (NDA) is usually the last step for a company, or sponsor, to be allowed to market and sell the drug. Alimera expects NDA submission later in 2010 after completion and analysis of the phase 3 data.
Alimera’s Iluvien is close to reality for the treatment of diabetic macular edema.
For fun, compare the status of this drug, Iluvien, to E10030. I wrote about Ophthotech’s E10030 a few days ago. E10030 is an anti-PDGF aptamer that treats wet macular degeneration. This drug is about to enter phase 2.