ANI Pharmaceuticals Announces Positive Phase 4 Open-Label, Single-Arm SYNCHRONICITY Clinical Trial Results Presented as Late Breaking Oral Presentation at the American Academy of Ophthalmology 2026 Annual Meeting
ANI Pharmaceuticals announced positive 6- and 24-month results from its Phase 4 SYNCHRONICITY trial of ILUVIEN in chronic non-infectious posterior segment uveitis, presented as a late-breaking oral at the AAO 2026 meeting. The open-label, single-arm study (n=108) met both co-primary endpoints at 6 months with statistical significance: +3.6 letters BCVA gain (p=0.0077) and -157.5 microns CST reduction (p<0.0001), with gains maintained at 24 months (+5.5 letters; -171.2 microns). 79.6% of study eyes had no inflammation recurrence over 24 months, and safety was consistent with prior trials of the implant.
Key figures
- Drug Name
- ILUVIEN (fluocinolone acetonide intravitreal implant 0.18 mg)
- Phase Of Trial
- Phase 4
- Trial name
- SYNCHRONICITY
- Itt population
- 108
- No recurrence 24mo pct
- 79.6%
- Cst change month6 microns
- -157.5
- Bcva change month6 letters
- 3.6
- Bcva change month24 letters
- 5.5
- Macular edema resolution month24 pct
- 48.2%
AI analysis
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