FDA grants priority review to fluocinolone for DME

Atlanta-Alimera Sciences announced the FDA’s acceptance for filing and granting of priority review status for a new drug application (NDA) for fluocinolone acetonide intravitreal insert (Iluvien).

The product is an investigative, extended-release intravitreal insert that the company is developing for the treatment of diabetic macular edema (DME). The insert is designed to have a therapeutic effect for up to 36 months and is inserted in the back of the eye in a manner facilitating a self-sealing wound.

“If approved,” said Dan Myers, president and chief executive officer of Alimera Sciences, “we believe that [fluocinolone acetonide] will be the first pharmaceutical in the United States indicated to treat this disease, and the first long-term treatment with the potential to be therapeutically effective for up to 36 months.”

FDA priority review status is granted to therapies that offer major advances in treatment or provide a treatment where no adequate therapy exists.

Alimera currently is conducting two phase III pivotal clinical trials for the intravitreal insert. The study will conclude later this year.