September 26, 2014 / 8:27 PM / 5 years ago

Alimera's eye implant Iluvien wins FDA approval

Sept 26 (Reuters) - The Food and Drug Administration has approved Alimera Sciences Inc’s and pSivida Corp’s vision-loss treatment Iluvien after three rejections.

The FDA approved Iluvien to treat a condition known as diabetic macular edema (DME), a swelling on the back of the retina that in the most severe cases can lead to blindness.

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.

PSivida said the approval entitles it to receive a milestone payment of $25 million.

The company licensed the implant to Alimera in February 2005 and will also get 20 percent of the profits from sales in the United States.

Iluvien is expected to launch early next year, pSivida said.

The treatment is already approved in 10 European countries, including the UK, France and Germany. (Reporting by Vidya L Nathan and Anjali Rao Koppala in Bangalore; Editing by Sriraj Kalluvila)

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