ANI Pharmaceuticals Report Two-Year Vision Improvements In Phase 4 Eye Disease Study
(RTTNews) - ANI Pharmaceuticals (ANIP) announced positive results from its Phase 4 SYNCHRONICITY trial evaluating the Fluocinolone Acetonide Intravitreal Implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye (chronic NIU-PS).
The findings were presented in a late-breaking oral presentation at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting.
Chronic non-infectious uveitis affecting the back of the eye is a serious inflammatory condition that can lead to vision loss if left untreated. Managing inflammation and preserving vision are key treatment goals for these patients.
The Phase 4 SYNCHRONICITY study enrolled 108 patients and evaluated the Fluocinolone Acetonide Intravitreal Implant in a real-world clinical setting. The trial met both of its co-primary endpoints at six months, demonstrating statistically significant improvements in best-corrected visual acuity (BCVA), a measure of vision, and reductions in central subfield thickness (CST), a marker of retinal swelling.
According to the data presented, these improvements were maintained through 24 months, a key secondary endpoint of the study.
The study's safety findings were consistent with previous clinical experience with the fluocinolone acetonide implant. The most commonly reported adverse events were similar to those observed in earlier trials of the treatment.
ILUVIEN is a sustained-release corticosteroid implant that delivers fluocinolone acetonide directly into the eye for up to 36 months. In the United States, it is approved for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye and diabetic macular edema in certain previously treated patients.
The implant is designed to provide long-term corticosteroid treatment directly inside the eye to help control inflammation associated with chronic uveitis and other retinal diseases.
ANI said the results add to the growing body of evidence supporting the use of the implant in patients with chronic NIU-PS, including those treated by retina specialists in routine clinical practice.
ANIP has traded in a 52-week range of $69.58 to $97.00. The stock closed Friday's trading (October 9, 2026) at $73.89, up 2.65%.
