Key Takeaways

  • SYNCHRONICITY met both co-primary endpoints at 6 months, with improvements in BCVA and CST maintained through 24 months

  • Nearly 80% of study eyes remained free of inflammatory recurrence over 24 months following a single implant

  • Safety findings were consistent with previous trials, with IOP elevation and cataract-related complications remaining important considerations

ANI Pharmaceuticals announced 6-month and 24-month results from its Phase 4 SYNCHRONICITY trial evaluating the fluocinolone acetonide intravitreal implant (Iluvien) in patients with chronic noninfectious uveitis affecting the posterior segment (NIU-PS).

The findings were presented by David R.P. Almeida, MD, MBA, PhD, principal investigator of SYNCHRONICITY, during Uveitis Subspecialty Day at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting in New Orleans.

The open-label, single-arm trial enrolled 108 patients and met both co-primary endpoints at month 6. Mean best-corrected visual acuity (BCVA) improved by 3.6 ETDRS letters (P=.0077), while mean central subfield thickness (CST) decreased by 157.5 µm (P<.0001).

At month 24, improvements were generally maintained, with mean BCVA increasing by 5.5 letters and mean CST decreasing by 171.2 µm from baseline.

Over the 24-month study period, 79.6% of study eyes (86/108) experienced no recurrence of noninfectious inflammation. Among eyes with recurrence, median time to recurrence was 168 days. At month 24, macular edema resolution was observed in 48.2% of study eyes, while vascular leakage decreased from 78.7% at baseline to 55.6%.

Safety findings were consistent with previous studies of the implant. Treatment-related adverse events occurred in 29% of patients, most commonly ocular hypertension (6%), cataract (5%), and reduced visual acuity (5%).

Intraocular pressure (IOP) reached at least 25 mmHg in 17.6% of patients, and 29.6% required IOP-lowering medication. Additionally, 7.4% underwent laser or surgical IOP-lowering intervention, and 14.8% underwent cataract surgery.

"SYNCHRONICITY followed patients with chronic NIU-PS for 2 years after a single implant. CST and visual acuity were improved at month 6 and remained improved at month 24, with a safety profile consistent with prior trials," Dr. Almeida said.

The findings provide additional long-term evidence regarding the efficacy and safety of fluocinolone acetonide intravitreal implantation in steroid-responsive patients with chronic NIU-PS.