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 non-infectious 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. As previously announced, the company plans to market 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.

“Iluvien's expanded label and the strengthening of our partnership with long-standing Iluvien contract manufacturer, Seigfried, will enhance supply security and access for appropriate NIU-PS and DME patients in need," said Nikhil Lalwani, president and CEO of ANI, in the press release.

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.