ANI Pharma Reports Positive Phase 4 Data For Fluocinolone Acetonide Implant In Chronic Uveitis

(RTTNews) - ANI Pharmaceuticals, Inc. (ANIP) on Monday reported positive topline results from its Phase 4 SYNCHRONICITY study evaluating fluocinolone acetonide intravitreal implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS).

The two-year study met both co-primary endpoints, demonstrating statistically significant improvements in best corrected visual acuity (BCVA) and central subfield thickness (CST) at six months in the intent-to-treat population of 108 patients.

Patients achieved a mean improvement of 3.6 letters in BCVA from baseline at six months, while mean CST decreased by 157.5 microns.

The implant is designed to provide continuous low-dose corticosteroid delivery for the treatment of chronic non-infectious posterior segment uveitis in patients who have previously responded to steroid therapy.

ANI said the most common adverse events observed in the study were consistent with those reported in prior trials of the fluocinolone acetonide intravitreal implant.

ANI Pharma shares closed at $82.07 on Friday, down 2.04%.