Clinical TrialJul 13, 2026, 06:51 AM
ANI Pharma's ILUVIEN Phase 4 Trial Meets Primary Endpoints
AI Summary
ANI Pharmaceuticals announced positive topline data from its Phase 4 SYNCHRONICITY clinical trial for Fluocinolone Acetonide Intravitreal Implant (ILUVIEN) in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The trial met both co-primary endpoints, showing statistically significant improvements in best corrected visual acuity (BCVA) and central subfield thickness (CST) at 6 months. Adverse events were consistent with prior trials, with ocular hypertension and cataract being the most common. The company plans to present detailed results at upcoming medical conferences in Q4 2026.
Key Highlights
- Phase 4 SYNCHRONICITY trial met both co-primary endpoints with statistical significance.
- Mean change in BCVA of +3.6 letters gained (p=<0.0077) at 6 months.
- Mean change in CST of -157.5 microns (p=<.0001) at 6 months.
- Most common adverse events were ocular hypertension (6%) and cataract (5%).
- 29% of patients experienced treatment-related adverse events.
- Detailed results will be presented at medical conferences in 4Q 2026.
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