FDA

Iluvien now approved for chronic non-infectious posterior uveitis

March 18, 2025

FDA approved Iluvien (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS).

Efficacy

Approval was based on data from two phase 3 randomized trials (NCT01694186 and NCT02746991) in which fluocinonolone acetonide (FAc) intravitreal implant was compared with sham injection. The primary efficacy endpoint in both trials was the proportion of patients who experienced uveitis recurrence within 6 months of follow-up. Recurrence was defined as either deterioration in visual acuity, vitreous haze attributable to non-infectious uveitis, or the need for rescue medications.

Uveitis recurrence rates at 6 months were significantly lower in the FAc implant group compared with the sham group:

• Study 1: 18% vs. 79%; difference, 60%; 95% confidence interval [CI], 41-73; P <0.01
• Study 2: 22% vs. 54%; difference, 32%; 95% CI, 15-48; P <0.01

Results at 12 months were similar:

• Study 1: 28% vs. 86%; difference, 58%; 95% CI, 40-70
• Study 2: 33% vs. 60%; difference, 27%; 95% CI, 9-43

Safety

For patients with NIU-PS, hypotony has been observed within 24 hours of injection. Patients should be monitored following intravitreal injection. Temporary blurring of vision has also been reported following injection of the implant.

Sources:

ANI Pharmaceuticals. Iluvien (fluocinolone acetonide intravitreal implant) [package insert]. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/201923s006lbl.pdf Revised March 2025. Accessed March 17, 2025.

ANI Pharmaceuticals Announces FDA Approval for Expansion of ILUVIEN® Label. ANI Pharmaceuticals. 2025. https://investor.anipharmaceuticals.com/news-releases/news-release-details/ani-pharmaceuticals-announces-fda-approval-expansion-iluvienr