ANI Pharmaceuticals, Inc. 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 (Iluvien; ANI Pharmaceuticals) in patients with chronic noninfectious uveitis affecting the posterior segment of the eye were presented in a late-breaking oral presentation during Uveitis Subspecialty Day 2026 at the American Academy of Ophthalmology 2026 meeting in New Orleans. The data were presented by David R.P. Almeida, MD, MBA, PhD, president and CEO of Erie Retina Research, and principal investigator in SYNCHRONICITY.

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. Patients in the ITT population had a mean change from baseline BCVA of +3.6 letters gained (P=.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 also had a mean change from baseline CST of -157.5 µm (P<.0001) at 6 months (mean CST of 505.7 µm at baseline compared to 348.8 µm at month 6).

Secondary efficacy outcomes showed that functional and anatomic changes were generally maintained at month 24 in the ITT population. At month 24, mean change from baseline in BCVA letter score in the study eye was +5.5 ETDRS letters in the ITT population. At month 24,mean change from baseline in CST was −171.2 µm in the ITT population. Recurrence was defined as an increase in CST of >100 µm 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 noninfectious inflammation. Among the 22 study eyes (20.4%) that experienced recurrence, median time to recurrence was 168 days.

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 <325 µm on Heidelberg Spectralis or <315 µm on Zeiss Cirrus. The proportion of study eyes with vascular leakage as measured by widefield fluorescein angiography decreased from 78.7% (n=85/108) at baseline to 55.6% (n=60/108) at month 24 in the ITT population.

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), cataract in 5% of patients (n=5), and visual acuity reduced in 5% of patients (n=5). Separately, 17.6% of patients (19/108) experienced intraocular pressure (IOP) of ≥25 mmHg, 4.6% of patients (5/108) experienced IOP of ≥35 mmHg. IOP-lowering medication was used by 32 patients (29.6%), and 7.4% of patients (8/108) required any laser or surgical IOP-lowering intervention. Cataract surgery was reported in 16 (14.8%) study eyes overall.