ANI Pharmaceuticals Secures FDA Approval for Expanded ILUVIEN Label

ANI Pharmaceuticals has received FDA approval for an expanded label for ILUVIEN, now indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). This marks a significant step in broadening access to ILUVIEN, which was previously approved for diabetic macular edema (DME). The expanded approval aligns the U.S. label with ILUVIEN’s existing approvals in multiple European countries, further reinforcing its role as a long-term treatment option for patients with retinal diseases.

CEO Nikhil Lalwani emphasized that this approval, along with ANI’s strengthened partnership with ILUVIEN’s contract manufacturer Siegfried, will help ensure a stable supply and better patient access. The company recently extended its supply agreement with Siegfried through 2029 and plans to upgrade its manufacturing line to expand production capacity. With this regulatory milestone, ANI Pharmaceuticals continues to advance its commitment to innovative ophthalmic treatments that improve patient outcomes.