August 04, 2025
2 min learn
Key takeaways:
- The NEW DAY research didn’t meet its major endpoint however confirmed good outcomes in secondary endpoints.
- A submit hoc evaluation achieved its major endpoint.
LONG BEACH, Calif. — Iluvien for diabetic macular edema demonstrated longer-lasting intervals between injections and noninferior visible acuity good points vs. aflibercept however didn’t meet the first endpoint of the NEW DAY research.
“Though the NEW DAY research didn’t meet its major endpoint, it yielded necessary and clinically significant insights,” Michael A. Singer, MD, who introduced the outcomes on the American Society of Retina Specialists annual assembly, instructed Healio.
The multicenter, masked, randomized, active-controlled, parallel-group research enrolled 306 intent-to-treat (ITT) sufferers with center-involving DME and greatest corrected visible acuity of 35 to 80 ETDRS letters within the research eye. The first endpoint was the imply variety of supplemental aflibercept injections wanted for therapy within the Iluvien (fluocinolone acetonide intravitreal implant, ANI Prescription drugs) arm (154 sufferers) vs. the Eylea (aflibercept, Regeneron) arm (152 sufferers) within the ITT inhabitants over 18 months.
The imply variety of supplemental injections within the Iluvien arm was 2.4 in contrast with 2.5 within the aflibercept arm, which was not statistically important. Nonetheless, the time to first supplemental aflibercept injection within the Iluvien arm was 185.4 days vs. 132.8 days within the aflibercept arm, which was “extremely statistically important,” Singer stated within the presentation.
“This helps Iluvien’s function as a long-acting possibility for DME, particularly in sufferers who’re tough to handle or have adherence challenges,” he instructed Healio. “The research reinforces the real-world sturdiness of the [fluocinolone acetonide] implant and highlights its potential to scale back therapy burden whereas sustaining illness management.”
Moreover, 11.5% of sufferers within the Iluvien arm gained 15 ETDRS letters vs. 10.3% within the aflibercept arm at 18 months. Sufferers handled with Iluvien additionally confirmed “numerically superior” ranges of central subfield thickness vs. these handled with aflibercept at a number of time factors beginning at 9 months.
The phakic standing of sufferers had no influence on BCVA over the research interval.
A submit hoc evaluation of contributors who adopted the research protocols met the first endpoint with statistical significance, demonstrating a imply variety of 1.8 supplemental aflibercept injections within the Iluvien arm and a couple of.5 within the aflibercept arm.
When it comes to security, NEW DAY confirmed “comparable charges of cataract and IOP as earlier [fluocinolone acetonide implant] trials, with no retinal detachments or endophthalmitis,” Singer stated within the presentation.
“Future analysis will deal with figuring out biomarkers and scientific traits that predict which sufferers are almost certainly to profit from Iluvien,” Singer instructed Healio. “Ongoing and deliberate sub-analyses from NEW DAY — together with evaluations of IOP predictability, [Diabetic Retinopathy Severity Scale] regression, OCT-based anatomical markers and cytokine profiles — might assist information extra personalised therapy selections. These findings might refine affected person choice, optimize security monitoring and in the end help simpler, individualized use of Iluvien in DME.”
Reference:
Sources/Disclosures
Collapse
Singer MA, et al. NEW DAY: Examine design, research websites, affected person enrollment: A research of intravitreal Iluvien (fluocinolone acetonide) implant as baseline remedy in sufferers with early diabetic macular edema (DME) (NEW DAY). Introduced at: American Society of Retina Specialists annual assembly; July 30-Aug. 2, 2025; Lengthy Seashore, California.
Disclosures:
Singer experiences being a guide and speaker for ANI Prescription drugs.
