ANI Pharmaceuticals reported positive topline results from its Phase 4 SYNCHRONICITY study evaluating a fluocinolone acetonide intravitreal implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye. The two-year study met both co-primary endpoints, showing statistically significant improvements in best corrected visual acuity and central subfield thickness at six months in the intent-to-treat population of 108 patients. Patients achieved a mean improvement of 3.6 letters in best corrected visual acuity from baseline, while mean central subfield thickness decreased by 157.5 microns. The implant is designed to provide continuous low-dose corticosteroid delivery for patients who have previously responded to steroid therapy. The most common adverse events were consistent with prior trials of the implant.
ANI Pharmaceuticals IncPositive Phase 4 data for fluocinolone acetonide implant shows efficacy in chronic uveitis.