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
Key Highlights
- ➤ANI (ANIP) reported SYNCHRONICITY met both co-primary endpoints statistically at six months
- ➤BCVA improved 3.6 ETDRS letters at six months (p =0.0077)
- ➤CST declined 157.5 microns at six months (p <0.0001)
- ➤BCVA and CST improvements were maintained through 24 months
- ➤IOP-lowering laser or surgery was required in 7.4% of patients
Expert Statements
Nikhil Lalwani, President and Chief Executive Officer of ANI Pharmaceuticals
“The positive 6 and 24-month results from the SYNCHRONICITY trial in steroid-responsive patients further support the use of fluocinolone acetonide intravitreal implant in patients with chronic NIU-PS being treated by retina specialists”
David R.P. Almeida, President and CEO of Erie Retina Research; Principal Investigator in SYNCHRONICITY
“SYNCHRONICITY followed patients with chronic NIU-PS for two 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. These data give retina specialists useful information for clinical decision-making in chronic NIU-PS”
* Trial met both co-primary endpoints of mean change from baseline in BCVA letter score and mean change from baseline in CST with statistical significance(1) at 6 months, and these changes were maintained at 24 months (a key secondary endpoint) * The most common adverse events reported were consistent with prior trials of fluocinolone acetonide intravitreal implant 0.18 mg * Study evaluated patients with chronic NIU-PS in the U.S.; most patients in the study were treated by retina specialists PRINCETON, N.J., Oct. 12, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (ANI or the Company) today announced that both 6-month and 24-month data from SYNCHRONICITY, its Phase 4, open-label, single-arm clinical trial of Fluocinolone Acetonide Intravitreal Implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS) were presented in a late-breaking oral presentation during Uveitis Subspecialty Day 2026 on October 9, 2026 by Dr. David R.P. Almeida, MD, MBA, PhD, President and CEO of Erie Retina Research, and Principal Investigator in SYNCHRONICITY, at the American Academy of Ophthalmology (AAO) 2026 Meeting in New Orleans.
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