ANI Pharmaceuticals Says Phase 4 Trial of Iluvien Meets Endpoints in Chronic NIU-PS

07:44 AM EDT, 10/12/2026 (MT Newswires) -- ANI Pharmaceuticals (ANIP) said Monday that its phase 4 follow-up study of Iluvien in chronic non-infectious uveitis affecting the posterior segment of the eye, of chronic NIU-PS, met the primary endpoints with statistical significance in the intent-to-treat group at six months and sustained efficacy through 24 months. The company said patients gained an average of 3.6 vision-test letters and saw a 157.5-micron reduction in retinal thickness at six months. The improvements were maintained at 24 months, with vision gains averaging 5.5 letters, while 79.6% of study eyes had no recurrence of inflammation, the company said. The company also said the most common adverse events reported were consistent with previous studies of fluocinolone acetonide intravitreal implant.