Biopharmaceutical company ANI Pharmaceuticals Inc (Nasdaq:ANIP) announced on Friday that the US Food and Drug Administration has approved an expanded label for ILUVIEN, adding an indication for chronic non-infectious uveitis affecting the posterior segment of the eye.

The updated label also includes revisions to the Warnings and Precautions section.

ANI plans to market ILUVIEN in the United States under the expanded label later this year, alongside its existing indication for diabetic macular edema. The treatment is already approved for both conditions in 17 European countries.

President and CEO Nikhil Lalwani highlighted the label expansion and ANI's strengthened partnership with contract manufacturer Siegfried Holding AG as key to improving supply security and patient access. ANI previously extended its ILUVIEN supply agreement with Siegfried through 2029.

Siegfried and ANI have also committed to upgrading manufacturing equipment and expanding production capacity.

ILUVIEN is a corticosteroid designed for patients who have previously received corticosteroid treatment without a significant rise in intraocular pressure.