ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) (ANI or the Company) today announced positive topline data from its Phase 4, open-label, single-arm SYNCHRONICITY clinical trial of Fluocinolone Acetonide Intravitreal Implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS).

Both co-primary endpoints assessing mean change from baseline in best corrected visual acuity (BCVA) letter score as measured by ETDRS and mean change from baseline in central subfield thickness (CST) as measured by SD-OCT at 6 months in the intent-to-treat (ITT) population (n=108) were met with statistical significance. Patients in the ITT population had a mean change in baseline BCVA of +3.6 letters gained (p= <0.0077) at 6 months (mean BCVA letter score of 62.5 at baseline compared to 65.8 at month 6). Patients in the ITT population had a mean change in baseline CST of -157.5 microns (p= <.0001) at 6 months (mean CST of 505.7 microns at baseline compared to 348.8 microns at month 6).

The most common adverse events seen in SYNCHRONICITY were consistent with prior trials of the fluocinolone acetonide intravitreal implant. In the safety population, 29% of patients (n=31/108) experienced treatment-related treatment-emergent adverse events; the most common were ocular hypertension in 6% of patients (n=7) and cataract in 5% of patients (n=5). Separately, 18% of patients (n=19/108) experienced an IOP increase of ≥25 mmHg, and 7% of patients (n=8/108) required any laser or surgical IOP-lowering intervention. Detailed results and additional analyses will be presented at medical conferences in 4Q 2026.