PRINCETON, N.J. — October 12, 2026
ANI Pharmaceuticals, Inc. announced positive six-month and 24-month results from SYNCHRONICITY, its Phase 4 clinical trial evaluating fluocinolone acetonide intravitreal implant 0.18 mg (ILUVIEN) in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS). The findings were presented as a late-breaking oral presentation during Uveitis Subspecialty Day at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting in New Orleans. The study met both co-primary endpoints at six months, demonstrating statistically significant improvements in best-corrected visual acuity (BCVA) and central subfield thickness (CST). These improvements were generally maintained through 24 months following a single implant. The trial also evaluated recurrence of inflammation, resolution of macular edema and vascular leakage, alongside safety outcomes. The results provide additional long-term clinical data on fluocinolone acetonide implant use in chronic NIU-PS, a potentially sight-threatening inflammatory condition. ANI said the findings may help inform treatment decisions by retina specialists managing appropriately selected patients with chronic posterior segment uveitis.
SYNCHRONICITY Meets Both Co-Primary Endpoints
The prospective, open-label, single-arm SYNCHRONICITY study enrolled patients in the United States with chronic NIU-PS who had previously responded to steroid therapy. The intent-to-treat population included 108 patients, who received a single intravitreal fluocinolone acetonide implant and were followed for two years. At Month 6, mean BCVA improved by 3.6 ETDRS letters from baseline, with a statistically significant p-value of 0.0077. Mean visual acuity letter scores increased from 62.5 at baseline to 65.8 at six months. The second co-primary endpoint also showed a significant change: mean CST decreased by 157.5 microns (p<0.0001), from 505.7 microns at baseline to 348.8 microns at Month 6. CST, measured using spectral-domain optical coherence tomography, provides an assessment of retinal thickness and can help evaluate macular edema associated with inflammation. These findings indicate improvements in both a functional measure of vision and an anatomical measure of retinal status. Because the study was open-label and did not include a concurrent control group, the results should be interpreted within the context of its design. Nevertheless, the six-month endpoint findings provide evidence of improvement following treatment in this patient population.
Visual and Anatomical Improvements Persist Through Month 24
At the 24-month assessment, the study continued to show improvements in visual acuity and retinal thickness. Mean BCVA change from baseline reached +5.5 ETDRS letters, while mean CST change was -171.2 microns. The longer-term findings also included measures of inflammatory recurrence and macular edema resolution. Over the 24-month study period, 86 of 108 study eyes (79.6%) experienced no recurrence of non-infectious inflammation. Among the 22 eyes that experienced recurrence, the median time to recurrence was 168 days. Recurrence was defined by an increase in CST of more than 100 microns or the investigator’s medical judgment. At Month 24, macular edema had resolved in 52 of 108 study eyes, representing 48.2% of the intent-to-treat population. Resolution criteria were based on specified CST thresholds using Heidelberg SPECTRALIS or Zeiss CIRRUS imaging systems. The proportion of eyes showing vascular leakage on wide-field fluorescein angiography also decreased, from 78.7% at baseline to 55.6% at Month 24. Together, these secondary findings provide a broader picture of treatment response beyond the primary visual acuity and retinal thickness measurements. The study’s single-arm design means the observed changes cannot establish comparative effectiveness against other treatments, and individual outcomes may vary.
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Safety Findings and Clinical Significance
The safety profile observed in SYNCHRONICITY was described as consistent with previous clinical trials of fluocinolone acetonide intravitreal implant. In the safety population, 29% of patients experienced treatment-related treatment-emergent adverse events. The most commonly reported treatment-related events included ocular hypertension in 6% of patients, cataract in 5%, and reduced visual acuity in 5%. Increased intraocular pressure (IOP) was an important monitoring consideration: 17.6% of patients experienced IOP of at least 25 mmHg, and 4.6% experienced IOP of at least 35 mmHg. IOP-lowering medication was used by 29.6% of patients, while 7.4% required a laser or surgical intervention to lower pressure. Cataract surgery was reported in 14.8% of study eyes over the study period. These findings reinforce the importance of monitoring eye pressure and cataract development in patients receiving sustained-release corticosteroid implants. ILUVIEN is designed to release fluocinolone acetonide within the eye for up to 36 months and is approved in the United States for chronic NIU-PS as well as certain patients with diabetic macular edema. ANI stated that the 24-month findings add useful evidence for retina specialists considering treatment for suitable patients with chronic inflammation. Treatment selection should account for the patient’s ocular history, contraindications and risk of steroid-related complications.
Source::ANI Pharmaceuticals press release
