ILUVIEN Meets Both Co-Primary Endpoints in Phase 4 SYNCHRONICITY Trial for Chronic Non-Infectious Uveitis
核心洞察
ANI Pharmaceuticals' Phase 4 SYNCHRONICITY trial of ILUVIEN met both co-primary endpoints with statistical significance at six months in 108 patients with chronic non-infectious uveitis affecting the posterior segment (搜索).
Patients gained a mean of 3.6 ETDRS letters in best corrected visual acuity (p=0.0077) and achieved a 157.5-micron reduction in central subfield thickness (p<0.0001) from baseline.
The safety profile was consistent with prior fluocinolone acetonide trials, with ocular hypertension in 6% of patients and 7% requiring laser or surgical IOP-lowering intervention.
ANI Pharmaceuticals has announced positive six-month topline data from its Phase 4 SYNCHRONICITY trial, with the fluocinolone acetonide intravitreal implant ILUVIEN meeting both co-primary endpoints with statistical significance in patients with chronic non-infectious uveitis affecting the posterior segment (搜索) (chronic NIU-PS).
The open-label, single-arm study enrolled 108 patients across the United States, the majority of whom were treated by retina specialists. At six months, patients in the intent-to-treat population gained a mean of 3.6 ETDRS letters in best corrected visual acuity (BCVA), improving from a baseline mean of 62.5 letters to 65.8 letters (p=0.0077). Central subfield thickness (CST), a key structural measure of retinal inflammation, fell by a mean of 157.5 microns — from 505.7 microns at baseline to 348.8 microns at month 6 (p<0.0001). This represents an approximately 31% reduction in retinal swelling.
"We are encouraged by the positive results from the SYNCHRONICITY trial, which continue to support the use of fluocinolone acetonide intravitreal implant in patients with chronic NIU-PS being treated by retina specialists," said Nikhil Lalwani, President and Chief Executive Officer of ANI.
Study Design and Patient Population
SYNCHRONICITY (NCT05322070) was a prospective, Phase 4, open-label, single-arm study with a two-year follow-up period. Patients received a single 0.18 mg fluocinolone acetonide intravitreal implant injection in the designated study eye and were followed for 24 months. The co-primary endpoints — mean change from baseline in BCVA letter score measured by ETDRS and mean change from baseline in CST measured by SD-OCT — were assessed at six months.
The study population reflected a real-world retina practice demographic: mean age of 64 years, 65% female, and heavily pretreated, with 69% of participants having a history of ocular surgery prior to enrollment. Patients were required to have a diagnosis of active, recurrent, unilateral or bilateral NIU-PS with a duration of at least three months from initial diagnosis. Those with ocular surgery within 12 weeks of Day 1 were excluded.
Safety Profile Consistent with Established Class Effects
In the safety population, 29% of patients (n=31/108) experienced treatment-related treatment-emergent adverse events. The most common were ocular hypertension in 6% of patients (n=7) and cataract in 5% (n=5). Separately, 18% of patients (n=19/108) experienced an intraocular pressure (IOP) increase of 25 mmHg or greater, and 7% (n=8/108) required laser or surgical IOP-lowering intervention. These findings align with the known safety profile of fluocinolone acetonide intravitreal implants established in prior trials.
Clinical and Commercial Significance
ILUVIEN received FDA approval for chronic NIU-PS in March 2025, consolidating labeling that had previously covered the same 0.18 mg dose under a separate product. The implant is designed to release fluocinolone acetonide continuously for up to 36 months. SYNCHRONICITY was not designed to support regulatory approval but rather to generate real-world-adjacent evidence among U.S. retina specialists — the physicians whose prescribing patterns ANI aims to influence.
"ILUVIEN is an established treatment option for patients with chronic non-infectious uveitis affecting the posterior segment (搜索) of the eye. The SYNCHRONICITY study adds clinically meaningful data about the use of ILUVIEN for the treatment of chronic NIU-PS in patients we see every day in our retina practices," said David Almeida, MD, MBA, PhD, President and CEO of Erie Retina Research and Principal Investigator in SYNCHRONICITY.
Detailed results and additional analyses will be presented at medical conferences in the fourth quarter of 2026. The 24-month follow-up data remain the critical next milestone, as they will determine whether the six-month structural and functional gains are sustained over the implant's extended release duration.