• 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.

Read more: https://www.healio.com/news/ophthalmology/20250804/study-supports-iluvien-as-longacting-option-in-diabetic-macular-edema?utm_source=selligent&utm_medium=email&utm_campaign=20250805OSN&utm_content=20250805OSN

Source: Healio

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