ANI Pharmaceuticals announced the US Food and Drug Administration (FDA) has approved an expanded label for Iluvien (fluocinolone acetonide intravitreal implant) that includes an indication for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye (NIU-PS). The approval also includes other updates to the label, including to the Warnings and Precautions section, the company said in a press release.

The company had announced that it will Iluvien for chronic NIU-PS, in addition to its current indication of diabetic macular edema (DME) in the United States. Iluvien is already approved for both DME and NIU-PS outside the United States, including in 17 European countries, the company said.

ANI previously announced that it extended its supply agreement for Iluvien with a subsidiary of Siegfried Holding AG (Seigfried) through 2029. Siegfried and ANI also agreed to upgrade equipment on the existing manufacturing line and significantly expand capacity. RP