ANI Pharmaceuticals reports positive uveitis trial results

• ANI Pharmaceuticals reported positive six-month results from the Phase 4 SYNCHRONICITY trial of its fluocinolone acetonide intravitreal implant.
• The study met both primary endpoints, showing improvements in vision and reductions in retinal thickness.
• ANI Pharmaceuticals said detailed trial results will be presented in the fourth quarter of 2026.

ANI Pharmaceuticals (NASDAQ:ANIP) reported positive six-month topline results from the Phase 4 SYNCHRONICITY trial evaluating fluocinolone acetonide intravitreal implant 0.18 mg in 108 patients with chronic non-infectious uveitis affecting the posterior segment.

The trial met both co-primary endpoints, with patients showing a statistically significant improvement in best corrected visual acuity and a reduction in central subfield thickness after six months of treatment.

In the intent-to-treat population, mean best corrected visual acuity improved by 3.6 ETDRS letters from 62.5 to 65.8 (p<0.0077), while mean central subfield thickness decreased by 157.5 microns from 505.7 to 348.8 (p<0.0001) at month six.

ANI Pharmaceuticals reported treatment-related adverse events in 29% of patients, including ocular hypertension in 6% and cataracts in 5%.

The fluocinolone acetonide intravitreal implant is designed to deliver corticosteroid treatment directly into the eye for patients with chronic inflammatory eye conditions.

ANI Pharmaceuticals develops, manufactures and markets specialty pharmaceutical products, including treatments across complex disease areas and niche therapeutic categories.