ANI Pharmaceuticals (ANIP) said Wednesday that its trial evaluating Iluvien in patients with diabetic macular edema, or DME, did not meet its primary endpoint.

The primary endpoint was the mean total number of supplemental aflibercept injections needed in the Iluvien arm compared with the aflibercept-only arm over 18 months. ANI said results showed while 154 patients in the Iluvien group showed a numerical reduction in injections compared with 152 in the aflibercept group, the difference did not reach statistical significance.

The trial's secondary endpoint was met, with the mean time to first supplemental injection at 185.4 days in the Iluvien group compared with 132.8 days for aflibercept arm. In addition, 33% of patients in the Iluvien arm required no supplemental injections during the study compared with 30% in the aflibercept group, the company said.

Iluvien was well tolerated in the trial, with a safety profile consistent with prior clinical trials, the company said.

ANI Pharmaceuticals shares were down more than 7% in recent Wednesday premarket activity.