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ANI Pharmaceuticals Announces Results from NEW DAY Clinical Trial of ILUVIEN® for Use in Patients with Diabetic Macular Edema (DME)
Trial evaluated number of supplemental injections needed for the treatment of DME for patients on ILUVIEN versus the aflibercept arm Study Enrolled
About this update from Ani Pharmaceuticals, Inc.
[{"type":"text","content":"Trial evaluated number of supplemental injections needed for the treatment of DME for patients on ILUVIEN versus the aflibercept arm Study Enrolled Treatment-Naïve, or Almost Naïve, Patients with DME Results presented by Michael A. Singer, M.D. in a paper-on-demand presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting Conference call scheduled for today at 8:30 am ET PRINCETON, N.J., July 23, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced results from the NEW DAY clinical trial of ILUVIEN® (fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN) for use in patients with diabetic macular edema (DME). The results were presented in a paper-on-demand presentation by Michael A. Singer, M.D., 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 (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 (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 (n=154) demonstrated a numerical reduction in the mean number of supplemental aflibercept injections compared to the aflibercept arm (n=152) but did not reach the threshold for statistical significance (2.4 vs. 2.5; p=0.756), 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 (n=154), compared to 132.8 days in the aflibercept arm (n=152) (p 1 intravitreal injection of ranibizumab or bevacizumab in the last 12 months; or had received ranibizumab or bevacizumab ≤ 6 weeks prior to the screening visit. Patients were also screened with a steroid challenge of difluprednate QID for 2 weeks. Patients who were determined to have an IOP ≥25 mmHg or an increase ≥8 mmHg from the sc...