Healthcare
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
Trial met both co-primary endpoints of mean change from baseline in BCVA letter score and mean change from baseline CST with statistical significance at 6 monthsThe most common adverse events reported were consistent with prior trials of fluocinolone acetonide intravitreal implant 0.18 mgStudy evaluated patients with chronic NIU-PS in the U.S. Most patients in the study were treated by retina specialists.Full results to be presented at an upcoming medical meeting PRINCETON, N.J., July 13, 2026 (
About this update from Ani Pharmaceuticals, Inc.
PRINCETON, N.J., July 13, 2026 (GLOBE NEWSWIRE) -- 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. "We are encouraged by the positive results from the SYNCHRONICITY trial, which continue to support the use of fluocinolone acetonide intravitreal implant in patients with chronic NIU-PS being treated by retina specialists," stated Nikhil Lalwani, President and Chief Executive Officer of ANI. "We look forward to sharing detailed results at medical conferences and continuing to engage the retina community."
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