Eye Implant Iluvien for Diabetic Macular Edema Clears FDA

By Reuters Staff

September 29, 2014

(Reuters) - The Food and Drug Administration has approved eye implant Iluvien, from Alimera Sciences and pSivida Corp, for treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP).

Iluvien is an injectable implant. The treatment involves positioning a tiny, cylindrical tube containing a drug on the back of the eye - the spot where DME typically forms.

Each Iluvien implant is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, 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 company release.

In a phase 3 clinical study of Iluvien, the most frequently reported adverse drug reactions included cataract development and increased ocular pressure.

Iluvien is expected to launch early next year.

The treatment is already approved in 10 European countries, including the UK, France and Germany.

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