ANI Pharmaceuticals Announces Positive Six-Month Topline Data from the Phase 4 Open-Label, Single-Arm SYNCHRONICITY Trial Evaluating Fluocinolone Acetonide Intravitreal Implant in Patients with Chronic Non-Infectious Uveitis

ANI Pharmaceuticals reported positive Phase 4 trial results for ILUVIEN (fluocinolone acetonide intravitreal implant) in treating chronic non-infectious uveitis affecting the posterior segment. The trial met both co-primary endpoints with statistically significant improvements in visual acuity (+3.6 letters) and central subfield thickness reduction (-157.5 microns) at 6 months. Safety profile was consistent with prior trials, with ocular hypertension (6%) and cataract (5%) as the most common adverse events.