August 04, 2025
2 min read
Key takeaways:
- The NEW DAY study did not meet its primary endpoint but showed good outcomes in secondary endpoints.
- A post hoc analysis achieved its primary endpoint.
LONG BEACH, Calif. — Iluvien for diabetic macular edema demonstrated longer-lasting intervals between injections and noninferior visual acuity gains vs. aflibercept but did not meet the primary endpoint of the NEW DAY study.
“Although the NEW DAY study did not meet its primary endpoint, it yielded important and clinically meaningful insights,” Michael A. Singer, MD, who presented the results at the American Society of Retina Specialists annual meeting, told Healio.
The multicenter, masked, randomized, active-controlled, parallel-group study enrolled 306 intent-to-treat (ITT) patients with center-involving DME and best corrected visual acuity of 35 to 80 ETDRS letters in the study eye. The primary endpoint was the mean number of supplemental aflibercept injections needed for treatment in the Iluvien (fluocinolone acetonide intravitreal implant, ANI Pharmaceuticals) arm (154 patients) vs. the Eylea (aflibercept, Regeneron) arm (152 patients) in the ITT population over 18 months.
The mean number of supplemental injections in the Iluvien arm was 2.4 compared with 2.5 in the aflibercept arm, which was not statistically significant. However, the time to first supplemental aflibercept injection in the Iluvien arm was 185.4 days vs. 132.8 days in the aflibercept arm, which was “highly statistically significant,” Singer said in the presentation.
“This supports Iluvien’s role as a long-acting option for DME, especially in patients who are difficult to manage or have adherence challenges,” he told Healio. “The study reinforces the real-world durability of the [fluocinolone acetonide] implant and highlights its potential to reduce treatment burden while maintaining disease control.”
Additionally, 11.5% of patients in the Iluvien arm gained 15 ETDRS letters vs. 10.3% in the aflibercept arm at 18 months. Patients treated with Iluvien also showed “numerically superior” levels of central subfield thickness vs. those treated with aflibercept at multiple time points starting at 9 months.
The phakic status of patients had no impact on BCVA over the study period.
A post hoc analysis of participants who followed the study protocols met the primary endpoint with statistical significance, demonstrating a mean number of 1.8 supplemental aflibercept injections in the Iluvien arm and 2.5 in the aflibercept arm.
In terms of safety, NEW DAY showed “similar rates of cataract and IOP as previous [fluocinolone acetonide implant] trials, with no retinal detachments or endophthalmitis,” Singer said in the presentation.
“Future research will focus on identifying biomarkers and clinical characteristics that predict which patients are most likely to benefit from Iluvien,” Singer told Healio. “Ongoing and planned sub-analyses from NEW DAY — including evaluations of IOP predictability, [Diabetic Retinopathy Severity Scale] regression, OCT-based anatomical markers and cytokine profiles — may help guide more personalized treatment decisions. These findings could refine patient selection, optimize safety monitoring and ultimately support more effective, individualized use of Iluvien in DME.”
Reference:
Sources/Disclosures
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Singer MA, et al. NEW DAY: Study design, study sites, patient enrollment: A study of intravitreal Iluvien (fluocinolone acetonide) implant as baseline therapy in patients with early diabetic macular edema (DME) (NEW DAY). Presented at: American Society of Retina Specialists annual meeting; July 30-Aug. 2, 2025; Long Beach, California.
Disclosures:
Singer reports being a consultant and speaker for ANI Pharmaceuticals.
