ANI Pharmaceuticals eye implant trial meets endpoints
- ANI Pharmaceuticals (NASDAQ:ANIP) reported that its Phase 4 SYNCHRONICITY trial met both primary endpoints for its fluocinolone acetonide intravitreal implant 0.18 mg in patients with chronic non-infectious inflammation of the back of the eye.
- Among 108 patients, the study showed a mean 3.6-letter improvement in best-corrected visual acuity and a 157.5-micron reduction in central retinal thickness at six months.
- ANI Pharmaceuticals said the results support continued use evaluation of the implant in steroid-responsive eye inflammation conditions.
ANI Pharmaceuticals (NASDAQ:ANIP) announced results from the U.S. open-label, single-arm Phase 4 SYNCHRONICITY study evaluating fluocinolone acetonide intravitreal implant 0.18 mg in patients with chronic non-infectious inflammation affecting the back of the eye.
The study evaluated patients who had previously responded to steroid therapy, with six-month results showing improvements in visual acuity and reductions in retinal thickness compared with baseline measurements.
At 24 months, patients showed a mean improvement of 5.5 letters in visual acuity and a reduction of 171.2 microns in central retinal thickness, while 79.6% of study eyes had no recurrence of inflammation.
ANI Pharmaceuticals reported that treatment-related adverse events occurred in 29% of patients, with 7.4% requiring laser or surgical intervention to reduce eye pressure and 14.8% of study eyes undergoing cataract surgery.
The company presented the SYNCHRONICITY results on October 9, 2026, at the American Academy of Ophthalmology meeting as part of its ophthalmology-focused product development activities.
