Alimera Sciences Limited (Hook, UK) has announced results from the US NEW DAY clinical trial evaluating ILUVIEN® as baseline therapy in patients with early diabetic macular edema (DME).
The findings were presented for the first time in Europe at the EURETINA Innovation Spotlight (EIS) in Paris (September 3) by Dr. Charles Wykoff of Retina Consultants of Texas.
This phase IV study is the first direct head-to-head comparison between ILUVIEN 190 micrograms intravitreal implant in applicator (fluocinolone acetonide) and the widely used anti-VEGF agent aflibercept (2mg). The trial enrolled 306 eyes across 42 US centres and followed patients for 18 months, assessing efficacy, safety, and treatment burden.
Patients were randomized to receive either a single ILUVIEN implant followed by supplemental aflibercept as needed, or aflibercept loading doses with continued supplemental aflibercept as required.
The study found that patients in the ILUVIEN arm required an average of 2.4 supplemental aflibercept injections compared to 2.5 injections in the aflibercept arm, meeting the trial’s primary endpoint (p=0.756). Over the 18 months, the ILUVIEN group underwent 3.4 total injections (1 ILUVIEN, 2.4 aflibercept), compared with 7.5 total injections in the aflibercept-only group – highlighting a substantial reduction in treatment burden.
Importantly, the mean time from last injection to the first supplemental injection was significantly longer in the ILUVIEN arm (185.4 days vs 132.8 days, p<0.001). One-third of patients receiving ILUVIEN required no supplemental injections during the trial.
“The results reinforce our understanding that while DME is VEGF-driven, inflammation also plays a role and data in both the intent-to-treat (ITT ) and the post-hoc patient (PP) populations support the use of ILUVIEN earlier in the treatment pathway,” said Dr. Michael A. Singer of the University of Texas Health Science Center.
Dr. Steve Morris, Vice President, Medical Director and Head of Medical Affairs at Alimera Sciences, commented: “While the NEW DAY trial follows the US label, we hope the results will be of interest to clinicians in Europe. It provides important clinical evidence supporting the earlier use of long-acting corticosteroids in the DME patient treatment pathway, demonstrating meaningful efficacy alongside a reduced treatment burden,"
Key takeaways
Anti-VEGF therapies are the standard of care in DMO but place a heavy treatment burden on patients and healthcare systems.
The NEW DAY study present the first robust evidence that early use of long-acting corticosteroid implants delivers comparable efficacy to anti-VEGF therapy, while significantly reducing injection frequency.
These results may support earlier consideration of long-acting corticosteroids in DMO treatment pathways, potentially informing updates to clinical guidelines and health policies.
