ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) announced that its Phase 4 SYNCHRONICITY clinical trial of fluocinolone acetonide intravitreal implant, marketed as ILUVIEN, met both co-primary endpoints at six months in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS).

The intent-to-treat population included 108 patients. Mean best corrected visual acuity improved by 3.6 letters from a baseline of 62.5 letters to 65.8 letters at six months (p=0.0077). Mean central subfield thickness decreased by 157.5 microns from a baseline of 505.7 microns to 348.8 microns at six months (p<0.0001).

In the safety population, 29% of patients experienced treatment-related adverse events. The most common were ocular hypertension in 6% of patients and cataract in 5%. An intraocular pressure increase of 25 mmHg or greater was observed in 18% of patients, and 7% required laser or surgical intervention to lower intraocular pressure.

The trial was a prospective, open-label, single-arm, two-year follow-up study conducted in the United States. The study population had a mean age of 64 years, and 65% of participants were female. Full results are expected to be presented at medical conferences in the fourth quarter of 2026.

ILUVIEN received FDA approval in 2014 for diabetic macular edema. In 2025, the FDA expanded its label to include treatment of chronic NIU-PS following a labeling consolidation of two bioequivalent strengths of fluocinolone acetonide into a single prescribing document.