ANI Pharmaceuticals Reports Findings from Iluvien DME Study

ANI Pharmaceuticals has reported results from its randomized, prospective NEW DAY trial assessing Iluvien 0.19 mg in patients with diabetic macular oedema (DME). Conducted across nearly 42 U.S. sites, the study included 306 eyes from adults with type 1 or 2 diabetes, either treatment-naïve or minimally treated, and exhibiting central involvement confirmed by SD-OCT. Participants had a central subfield thickness of ≥350µm and BCVA between 35–80 ETDRS letters. Patients were randomized to receive either a single Iluvien implant or five monthly aflibercept injections, followed by as-needed dosing. The primary endpoint—mean number of supplemental aflibercept injections over 18 months—was not statistically significant. However, Iluvien significantly delayed the need for the first supplemental injection (185.4 vs. 132.8 days). A post-hoc analysis also showed fewer injections in protocol-compliant Iluvien patients. Safety outcomes aligned with past data, with 41% experiencing adverse effects, mainly cataracts and elevated intraocular pressure.

28-07-2025