The U.S. Food and Drug Administration has approved an expanded label for a novel fluocinolone acetonide intravitreal implant (ILUVIEN) to include the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye. The implant was previously indicated for diabetic macular edema in patients who received treatment with corticosteroids without a significant intraocular pressure rise.

The label expansion also included updates to the Warnings and Precautions section of the prescribing information. ANI Pharmaceuticals intends to begin marketing the novel implant in the United States for both noninfectious uveitis affecting the posterior segment of the eye (NIU-PS) and diabetic macular edema (DME) later in 2025, they noted in a press release. The fluocinolone acetonide intravitreal implant has already been approved for both indications outside the United States, including in 17 European countries.

The novel implant is a sustained-release intravitreal corticosteroid implant designed to provide continuous microdosing of fluocinolone acetonide. The approval expanded treatment options among patients with chronic NIU-PS, a leading cause of vision loss that is characterized by inflammation in the back of the eye.

According to clinical trials, ocular adverse reactions in patients with NIU-PS include cataracts, visual acuity reduction, macular edema, and uveitis. Intraocular pressure (IOP) elevation of at least 10 mmHg was seen in 22% of these patients (compared with 12% of controls), while IOP elevation of at least 30 mmHg was seen in 12% of patients with NIU-PS (compared with 3% of controls). Further information about adverse reactions, contraindications, and other safety information in patients with NIU-PS and patients with DME can be found in the press release.

ANI Pharmaceuticals’ manufacturing agreement with Siegfried Holding AG has been extended through 2029, which “will enhance supply security and access for appropriate [patients with] NIU-PS and DME in need,” commented Nikhil Lalwani, President and CEO of ANI Pharmaceuticals.