ANI Pharmaceuticals reports results from clinical trial of Iluvien

ANI Pharmaceuticals (ANIP) announced results from the NEW DAY clinical trial of ILUVIEN, or fluocinolone acetonide intravitreal implant, 0.19 mg for use in patients with diabetic macular edema, or DME. The results were presented in a paper-on-demand presentation by Michael A. Singer, Clinical Professor of Ophthalmology at University of Texas Health Science Center and Director of Clinical Research at Medical Center Ophthalmology Associates in Texas, for the American Society of Retina Specialists, or ASRS, Annual Scientific Meeting. The primary endpoint of the trial was the mean total number of supplemental aflibercept injections needed for the treatment of DME in the ILUVIEN arm compared to the aflibercept arm over the 18-month study period in the intent-to-treat, or ITT, population. Patients were randomized to an induction phase to receive either a single ILUVIEN injection or a series of 5 monthly injections of aflibercept, followed by supplemental aflibercept injections as needed. Treatment with ILUVIEN demonstrated a numerical reduction in the mean number of supplemental aflibercept injections compared to the aflibercept arm but did not reach the threshold for statistical significance, and therefore the primary endpoint was not met. The secondary endpoint of mean time from last treatment injection to first supplemental aflibercept injection was met with a mean time of 185.4 days in the ILUVIEN arm compared to 132.8 days in the aflibercept arm. 33% of patients in the ILUVIEN arm did not require a supplemental injection during the study compared to thirty percent in the aflibercept arm. A post-hoc analysis was conducted on a subset of randomized patients without major protocol deviations-such as being enrolled or randomized despite not meeting eligibility criteria, receiving incorrect treatment, or being administered prohibited concomitant medications or therapies. In this Post-Hoc Patient Population, the ILUVIEN arm demonstrated a statistically significant difference in the mean number of supplemental aflibercept injections compared to the aflibercept arm, with 1.8 vs. 2.5 injections, respectively. For safety, ILUVIEN was well tolerated in the trial, with a safety profile that is consistent with data from prior ILUVIEN clinical trials and real-world use.