FDA Approves Expanded Label for Iluvien to Include Chronic Noninfectious Uveitis

The FDA has approved an expanded label for Iluvien, allowing its use for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye, ANI Pharmaceuticals announced in a press release. The update enhances treatment options for patients with this vision-threatening condition.

Expanded Indications for Iluvien

Iluvien (fluocinolone acetonide intravitreal implant) was previously approved for diabetic macular edema (DME) in the U.S. and has been used for both DME and noninfectious uveitis affecting the posterior segment (NIU-PS) in 17 countries across Europe. With this new approval, Iluvien's label has been updated to reflect its broader application, providing an additional option for U.S. patients dealing with NIU-PS.

Strengthening Market Access and Supply

ANI Pharmaceuticals plans to initiate marketing under the combined label later this year, ensuring greater accessibility for patients. Additionally, the company has reinforced its partnership with Iluvien's contract manufacturer, Siegfried Holding, extending their supply agreement through 2029.

Industry Perspective

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

Conclusion

The FDA’s approval marks an important step in broadening the therapeutic reach of Iluvien, offering new hope for patients with NIU-PS while solidifying ANI Pharmaceuticals’ presence in the ophthalmic treatment landscape.