ANI Reports Long-Term Uveitis Results Alongside IOP-Related Safety Findings

ANI Pharmaceuticals reported positive six-month and 24-month results from SYNCHRONICITY, a Phase 4 study evaluating fluocinolone acetonide intravitreal implant 0.18 mg in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS). The findings were presented during Uveitis Subspecialty Day at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting in New Orleans on October 9.

The study met both co-primary endpoints at six months, showing improvements in best-corrected visual acuity (BCVA) and reductions in central subfield thickness (CST). Improvements in both measures were observed at 24 months following a single implant administration. However, the open-label, single-arm design limits comparisons with alternative treatments, and the company noted that all statistical analyses were descriptive and p-values were nominal.

Six-Month Results Show Improvements in Vision and Retinal Thickness

SYNCHRONICITY (NCT05322070) met its co-primary endpoints in the intent-to-treat population of 108 patients at Month 6.

Mean BCVA improved by 3.6 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, from 62.5 at baseline to 65.8 at Month 6. The reported p-value was 0.0077. Mean CST decreased by 157.5 microns, from 505.7 to 348.8 microns, with a reported p-value below 0.0001.

BCVA measures visual function, while CST assessed using spectral-domain optical coherence tomography (SD-OCT) provides an anatomical measure of retinal thickness. The findings therefore indicate changes in both visual acuity and retinal anatomy during treatment.

Although both endpoints met the study’s reported statistical criteria, the nominal p-values and descriptive nature of the analyses should be considered when interpreting the findings.

Improvements Observed at 24 Months

The secondary efficacy outcomes showed that changes in vision and retinal thickness were generally maintained through Month 24.

Mean BCVA improvement reached 5.5 ETDRS letters from baseline, while mean CST decreased by 171.2 microns. These results extend the follow-up evidence beyond the six-month primary assessment, although the absence of a comparator prevents conclusions about relative efficacy.

Inflammatory recurrence was another important outcome. Over the 24-month study period, 86 of 108 study eyes (79.6%) experienced no recurrence of non-infectious inflammation. Among the 22 eyes that experienced recurrence, the median time to recurrence was 168 days. Recurrence was defined as an increase in CST of more than 100 microns or according to the investigator’s medical judgment.

At Month 24, macular oedema had resolved in 52 of 108 study eyes (48.2%), based on the study’s specified CST thresholds for the imaging systems used. The proportion of eyes with vascular leakage, assessed using wide-field fluorescein angiography, decreased from 78.7% (85/108) at baseline to 55.6% (60/108) at Month 24.

Together, these outcomes provide information on visual function, retinal anatomy and inflammatory recurrence. However, the findings do not establish that every patient maintained improvement or remained free of recurrence.

Safety Findings Highlight the Need for Monitoring

The safety profile was generally consistent with previous trials of the fluocinolone acetonide intravitreal implant. Treatment-related treatment-emergent adverse events were reported in 31 of 108 patients (29%). The most frequently reported events were ocular hypertension in seven patients (6%), cataract in five (5%) and reduced visual acuity in five (5%).

Intraocular pressure (IOP) elevations were also reported. Nineteen patients (17.6%) recorded IOP of at least 25 mmHg, while five (4.6%) reached at least 35 mmHg. IOP-lowering medication was used by 32 patients (29.6%), and eight (7.4%) underwent laser or surgical intervention to reduce IOP. Cataract surgery was reported in 16 study eyes (14.8%).

These findings make pressure monitoring an important consideration when interpreting the implant’s longer-term safety profile. The overall consistency with previous trials does not eliminate the need to assess individual risks and monitor patients during follow-up.

Trial Design and Clinical Interpretation

SYNCHRONICITY (NCT05322070) was a prospective, US-based, Phase 4, open-label, single-arm study with two years of follow-up. It evaluated fluocinolone acetonide intravitreal implant 0.18 mg in patients with chronic NIU-PS who had responded to previous steroid therapy. The primary endpoints were changes from baseline in BCVA and CST at six months.

The study population had a mean age of 64 years, and 65% of participants were female. Approximately 69% had a history of ocular surgery before enrolment; patients who underwent ocular surgery within 12 weeks before Day 1 were excluded.

The findings add two-year follow-up data after a single implant administration, with observed improvements in visual acuity and retinal thickness alongside information on recurrence and safety. Nevertheless, the single-arm design and descriptive statistical analyses limit the conclusions that can be drawn about comparative treatment effects. The results provide additional evidence for clinical assessment of fluocinolone acetonide intravitreal implant in appropriately selected patients with chronic NIU-PS.

Reference

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, 12 October 2026

Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis, ClinicalTrials.gov ID NCT05322070