FDA Approves Eye Implant for Diabetic Macular Edema

The FDA approved eye implant fluocinolone acetonide intravitreal implant (Iluvien^®) for the treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

The drug is an injectable implant, manufactured by Alimera Sciences and pSivida Corp. The treatment involves positioning a tiny, cylindrical tube containing a drug on the back of the eye, where diabetic macular edema usually forms.

Each fluocinolone acetonide intravitreal implant is designed to release submicrogram levels of fluocinolone acetonide for 36 months.

“Corticosteroids have a history of effective use in treating ocular disease inflammation. Iluvien^® is injected in the back of the patient's eye with an applicator that employs a 25-gauge needle, which allows for a self-sealing wound,” according to a news release from the manufacturer.

In a phase 3 clinical study of fluocinolone acetonide intravitreal implant, the most frequently reported adverse events associated with the drug were cataract development and increased ocular pressure.

Fluocinolone acetonide intravitreal implant is expected to launch early next year. The treatment is already approved in 10 European countries, including the United Kingdom, France, and Germany.—Kerri Fitzgerald