ILUVIEN (fluocinolone acetonide intravitreal implant) - (SYNCHRONICITY)

October 12, 2026: ANI Pharmaceuticals (NASDAQ: ANIP) reported 6-month and 24-month Phase 4 SYNCHRONICITY data for ILUVIEN (fluocinolone acetonide intravitreal implant 0.18 mg) in chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS), presented October 9, 2026 in a late-breaking oral session at Uveitis Subspecialty Day during the AAO 2026 Meeting.

In the U.S. open-label, single-arm study (ITT n=108), both 6-month co-primary endpoints were met with nominal statistical significance: BCVA improved by +3.6 ETDRS letters (p=0.0077) and central subfield thickness (CST) decreased by 157.5 microns (p<0.0001). At 24 months, effects were generally maintained, with mean BCVA improvement of +5.5 letters and CST reduction of 171.2 microns. Over 24 months, 79.6% of study eyes had no recurrence of non-infectious inflammation; among recurrent cases, median time to recurrence was 168 days. Macular edema resolution was seen in 48.2% of eyes at month 24, and vascular leakage fell from 78.7% at baseline to 55.6% at month 24.

Safety was described as consistent with prior trials. Treatment-related adverse events occurred in 29% of patients; most common were ocular hypertension (6%), cataract (5%), and reduced visual acuity (5%).