ANI reports positive 6- and 24-month SYNCHRONICITY data

what happened

GlobeNewswire reported that ANI Pharmaceuticals presented 6- and 24-month results from SYNCHRONICITY at the American Academy of Ophthalmology’s 2026 annual meeting in New Orleans. The late-breaking presentation took place on October 9 during Uveitis Subspecialty Day and was delivered by Dr. David R.P. Almeida, the study’s principal investigator. The U.S. Phase 4 trial was open-label and single-arm; participants received one 0.18 mg fluocinolone acetonide implant injection and were followed for 24 months.

Both co-primary endpoints were met with statistical significance at Month 6 in the intent-to-treat population of 108 patients. Mean ETDRS best-corrected visual acuity increased by 3.6 letters, from 62.5 at baseline to 65.8 (p=0.0077), while mean central subfield thickness measured by SD-OCT fell by 157.5 microns. During the 24-month period, 86 of 108 study eyes, or 79.6%, had no recurrence of inflammation; among the 22 eyes with recurrence, the median time to recurrence was 168 days. Macular edema had resolved in 52 of 108 eyes, or 48.2%, by Month 24, while vascular leakage declined from 78.7% at baseline to 55.6%.

Treatment-related treatment-emergent adverse events occurred in 29% of patients. The most common were ocular hypertension in 6%, cataract in 5% and reduced visual acuity in 5%. Intraocular pressure of at least 25 mmHg was recorded in 17.6% of patients, while 4.6% reached at least 35 mmHg; 32 patients used pressure-lowering medication and 7.4% required laser or surgical intervention. Cataract surgery was reported in 16 study eyes. The FDA approved ILUVIEN in 2014 for diabetic macular edema and, in 2025, expanded its labeling to include chronic non-infectious uveitis affecting the posterior segment.

why it matters

The data add longer-term clinical evidence for ILUVIEN in chronic non-infectious posterior uveitis, while also detailing the rates of pressure-related complications and related interventions.

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