ANI Pharmaceuticals has disclosed the outcomes of its randomised NEW DAY trial, assessing Iluvien 0.19mg, in people with diabetic macular oedema (DME).
The multicenter, prospective, masked, active-controlled trial involved 306 eyes from patients who were either treatment-naïve or nearly treatment-naïve at nearly 42 US sites.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Participants in the trial were adults diagnosed with either type 1 or type 2 diabetes, exhibiting central involvement in diabetic macular oedema, as confirmed by SD-OCT, and had a central subfield thickness (CST) of at least 350µm.
Their best corrected visual acuity (BCVA) ranged between 35 and 80 early treatment diabetic retinopathy study (ETDRS) letters at the time of screening.
The primary goal of the study was to compare the mean total number of supplemental aflibercept injections required over an 18-month period between the Iluvien and aflibercept treatment groups.
Subjects were initially randomised to receive either a single Iluvien injection or a series of five monthly aflibercept injections, with subsequent aflibercept injections administered as needed.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataResults showed that the Iluvien group had a slight numerical decrease in the mean number of supplemental aflibercept injections against the aflibercept group (2.4 versus 2.5), but this did not achieve statistical significance, leading to the primary endpoint not being met.
However, the secondary endpoint regarding the mean time to first supplemental aflibercept injection was achieved, with the Iluvien group averaging 185.4 days, significantly longer than the 132.8 days in the aflibercept group.
A further post-hoc analysis of a subset of patients with no major protocol deviations revealed a significant variation in the mean number of supplemental aflibercept injections for the Iluvien group against the aflibercept group (1.8 versus 2.5).
ANI Pharmaceuticals president and CEO Nikhil Lalwani said: “We believe these data have the potential to support earlier usage of Iluvien as part of its role in reducing treatment burden in DME.”
Iluvien is approved for use in diabetic macular oedema patients who have previously undergone corticosteroid treatment without significant increases in intraocular pressure.
It is not recommended for patients with active or suspected eye infections or certain viral diseases.
Additionally, secondary endpoints that evaluated visual acuity and anatomic changes in the intent-to-treat (ITT) population showed non-inferiority between the Iluvien arm and the aflibercept arm.
Safety profiles for Iluvien were found to be consistent with previous clinical trials and real-world data, although 41% of Iluvien-treated patients experienced treatment-related adverse events, particularly related to cataract formation and increased intraocular pressure.
In May 2025, ANI Pharmaceuticals started a Phase IV trial to compare two dosage levels of Purified Cortrophin Gel for acute gout flare treatment.
