- Trial met both co-primary endpoints of mean change from baseline in BCVA letter score and mean change from baseline in CST with statistical significance1 at 6 months, and these changes were maintained at 24 months (a key secondary endpoint)
- The most common adverse events reported were consistent with prior trials of fluocinolone acetonide intravitreal implant 0.18 mg
- Study evaluated patients with chronic NIU-PS in the U.S.; most patients in the study were treated by retina specialists
PRINCETON, N.J., Oct. 12, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that both 6-month and 24-month data from SYNCHRONICITY, its Phase 4, open-label, single-arm clinical trial of Fluocinolone Acetonide Intravitreal Implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS) were presented in a late-breaking oral presentation during Uveitis Subspecialty Day 2026 on October 9, 2026 by Dr. David R.P. Almeida, MD, MBA, PhD, President and CEO of Erie Retina Research, and Principal Investigator in SYNCHRONICITY, at the American Academy of Ophthalmology (AAO) 2026 Meeting in New Orleans.
Co-primary Endpoints
The trial met both co-primary endpoints with statistical significance in the intent-to-treat (ITT) population (n=108) at 6 months: 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.
- Mean Change from Baseline in BCVA Letter Score at Month 6: Patients in the ITT population had a mean change from 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).
- Mean Change from Baseline in CST at Month 6: Patients in the ITT population also had a mean change from baseline CST of -157.5 microns (p100 microns or based on the investigator’s medical judgment. Over the 24-month study period, 86 of 108 study eyes (79.6%) experienced no recurrence of non-infectious inflammation. Among the 22 study eyes (20.4%) that experienced recurrence, median time to recurrence was 168 days.
- Proportion of Study Eyes with Resolution of Macular Edema: The proportion of study eyes with resolution of macular edema increased during the early treatment period and remained generally stable through Month 24 in the ITT population, with 48.2% (n= 52/108) of study eyes meeting the criteria for resolution at Month 24. Resolution of macular edema was defined as a central subfield thickness (CST) of