ANI Pharmaceuticals (ANIP) said Monday that its phase 4 trial evaluating the fluocinolone acetonide intravitreal implant in patients with chronic non-infectious uveitis met both co-primary endpoints.
The company said that both co-primary endpoints assessing the mean change from baseline in best-corrected visual acuity letter score and central subfield thickness at six months were met with statistical significance.
ANI said that the most common adverse events seen in the latest study were consistent with prior trials of the fluocinolone acetonide intravitreal implant.
Full results from the trial will be presented at an upcoming medical meeting, the company said.
The study was conducted in patients with chronic non-infectious uveitis affecting the posterior segment of the eye, a sight-threatening recurrent inflammatory condition, ANI said.