ILUVIEN Posts Positive Six-Month Results in Phase 4 Uveitis Trial
ANI Pharmaceuticals' SYNCHRONICITY study hits both co-primary endpoints for fluocinolone acetonide implant in chronic non-infectious uveitis, with full data set for release later this year.
ANI Pharmaceuticals has reported positive topline results from its Phase 4 SYNCHRONICITY trial, with the fluocinolone acetonide intravitreal implant (marketed as ILUVIEN) meeting both co-primary endpoints in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS).
The open-label, single-arm study enrolled 108 patients in the US and tracked outcomes at six months against two visual and structural measures: change in best corrected visual acuity (BCVA) letter score, and change in central subfield thickness (CST).
The numbers
In the intent-to-treat population, mean BCVA improved from 62.5 letters at baseline to 65.8 letters at six months, a gain of 3.6 letters (p<0.0077). CST fell from a mean of 505.7 microns at baseline to 348.8 microns, a reduction of 157.5 microns (p<0.0001).
On safety, treatment-related adverse events were recorded in 29 per cent of patients (31 of 108), with ocular hypertension (6 per cent) and cataract (5 per cent) the most frequent. A rise in intraocular pressure of 25 mmHg or more was seen in 18 per cent of patients, and 7 per cent required laser or surgical intervention to bring pressure down. ANI says the safety profile is consistent with earlier trials of the implant.
The study population skewed older and female, with a mean age of 64 and women making up 65 per cent of participants. Around 69 per cent had a history of ocular surgery prior to enrolment, though anyone who had undergone surgery within 12 weeks of Day 1 was excluded.
What the company is saying
Nikhil Lalwani, President and CEO of ANI, said the results reinforced the implant's role in a condition regularly seen by retina specialists. Principal investigator David Almeida, of Erie Retina Research, described the findings as adding clinically meaningful data on ILUVIEN's use in chronic NIU-PS patients seen routinely in retina practices.
Full results and further analyses are slated for presentation at medical conferences in the fourth quarter of 2026.
Context for the label
ILUVIEN, which releases fluocinolone acetonide over as long as 36 months, was first approved by the FDA in 2014 for diabetic macular edema in patients previously treated with corticosteroids who hadn't shown a significant IOP rise. In 2025, the FDA consolidated the prescribing information for two bioequivalent strengths of fluocinolone acetonide, a move that extended the ILUVIEN label to cover chronic NIU-PS.
SYNCHRONICITY (NCT05322070) is a two-year follow-up study; the six-month data reported now covers only the primary endpoints, with patients continuing to be monitored out to 24 months.
