Iluvien(R) (fluocinolone acetonide intravitreal insert), an investigational sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide for DME (diabetic macular edema) treatment, has been accepted for filing and granted Priority Review States by the FDA (Food and Drug Administration, USA), Alimera Sciences, Inc. announced today.

When a therapy offers major treatment advances, or provides a treatment where no adequate therapy is currently available, the FDA can grant Priority Review status. This status reduces the review time from about 10 to 6 months. Alimara says it should receive an FDA response in the fourth quarter regarding its NDA (New Drug Application) for Iluvien, which was submitted for approval in June 2010.

Dan Myers, president and CEO of Alimera Sciences:said

Receiving Priority Review status from the FDA marks another important milestone in our efforts to provide an approved therapeutic option to DME patients. If approved, we believe that Iluvien will be the first pharmaceutical in the U.S. indicated to treat this disease, and the first long-term treatment with the potential to be therapeutically effective for up to 36 months.”

Two Phase 3 pivotal clinical trials are currently underway – the FAME study – for Iluvien with 956 patients in sites across Europe, Canada, the USA and India to evaluate the efficacy and safety of the medication in a high and low dose for the treatment of diabetic macular edema.

The FAME study’s primary efficacy endpoint is the difference in the proportion of patients whose corrected visual acuity improved by at least 15% or more letters from baseline on the ETDRS eye chart at month 24 between treatment and control groups. The company says the FAME study will end later this year with the final patient visits at the three-year data point.

Alimera also submitted a Marketing Authorization Application to the MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom), as well as to regulatory authorities in Austria, France, Germany, Italy, Portugal and Spain. Submission for approval in Canada is expected to occur in September.

About diabetic macular edema

Diabetic macular edema, also known as DME, is the main cause of vision loss linked to diabetic retinopathy, a disease which affects the macula, a part of the retina responsible for central vision.

Blood vessel leakage causes macula swelling (DME). DME usually has no symptoms initially, the patient may not be aware of it until blurring of central vision or acute vision loss occurs. Blurring may range from mild to profound vision loss.

According to the Wisconsin Epidemiologic Study of Diabetic Retinopathy, over a 10-year period about 19% of individuals with diabetes in a study were diagnosed with DME. The number of newly diagnosed DME cases is expected to rise as the population of patients with diabetes increases.

About Iluvien

According to a Alimera press release:

Iluvien is an investigative, extended release intravitreal insert that Alimera is developing for the treatment of DME. Each Iluvien insert is designed to provide a therapeutic effect of up to 36 months by delivering sustained sub-microgram levels of fluocinolone acetonide. Iluvien is inserted in the back of the patient’s eye to a position that takes advantage of the eye’s natural fluid dynamics. The insertion device employs a 25-gauge needle, which allows for a self-sealing wound.

Source: Alimera Sciences, Inc., FDA.

Written by Christian Nordqvist