26doc133 10.3205/26doc133 urn:nbn:de:0183-26doc1335 Meeting Abstract Riemann Riemann Christopher D. CD

Cincinnati Eye Institute, OH, USA

author Singer Singer Michael M

Medical Center Ophthalmology Associates, Texas, USA

author Wykoff Wykoff Charles C. CC

Retina Consultants of Texas, Texas, USA

author Gonzalez Gonzalez Victor H. VH

Valley Retina Institute, Texas, USA

author Weng Weng Christina Y. CY

Baylor College of Medicine, Texas, USA

author Alkhatib Alkhatib Kamel K

ANI Pharmaceuticals Inc., Baudette, MN, USA

author Pao Pao Mary M

ANI Pharmaceuticals Inc., Baudette, MN, USA

author German Medical Science GMS Publishing House

Düsseldorf

610 20260617 engl This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). M0651 133 38. Internationaler Kongress der Deutschen Ophthalmochirurgie (DOC) Retina Nürnberg 20260618 20260620 EPO 6.2 TextPurpose: NEW DAY was a prospective, randomized, active-controlled, multicenter, phase 4, 18-month study (ClinicalTrials.gov ID NCT04469595). The study assessed the efficacy and safety of the fluocinolone acetonide (FAc; 0.19 mg) intravitreal implant as a baseline therapy in patients with center-involving diabetic macular edema (DME). Here we focus on reducing injection treatment burden.Methods: The study compared two treatment regimens: FAc implant followed by supplemental aflibercept (AFL; 2 mg/0.05 mL) versus intravitreal AFL loading doses (2 mg every 4 weeks for 5 consecutive doses) followed by supplemental AFL (2 mg/0.05 mL). Inclusion criteria were: adult patients with type 1 or type 2 diabetes, center-involving DME, and treatment naïve or nearly naïve (≤1 intravitreal ranibizumab or bevacizumab injection in the 12 months before screening; or ≤4 intravitreal anti-VEGF injections >12 months before screening). The primary endpoint was the mean number of supplemental AFL injections. Efficacy and safety were assessed in all randomized patients regardless of whether they received treatment.Results: 517 participants were screened and 306 were randomized. In terms of the primary endpoint, mean (SD) supplemental AFL injections were FAc: 2.4 (3.17), and aflibercept: 2.5 (3.07) (P=0.76). Total number of injections including FAc and AFL loading, were 3.4 (3.17) and 7.2 (3.42) (P<0.001). Time to rescue after the last mandated injection was 185.4 (97.9) and 132.8 (94.0) days (P<0.001), respectively, with a mean difference of 52.6 (96.0) days. In total, 32.5% and 30.3% (P=0.68) of FAc and AFL patients, respectively, received no supplemental injections. BCVA and CST were generally similar between groups. Cataract procedures occurred in 27.9% (FAc) and 6.6% (AFL); IOP increase events (IOP=10 mmHg from baseline) occurred in 15.6% (FAc) and 3.3% (AFL). Incisional surgery for IOP elevation occurred in 1.9% (FAc) and 0.0% (AFL).Conclusions: F Functional and anatomical measures were non-inferior between FAc and AFL. Injection treatment burden was reduced in the FAc group compared with the AFL group as indicated by the lower total number of injections, and the longer interval between injections. However, the number of patients receiving no supplemental therapy was similar (~one-third) in both FAc and AFL groups. Safety findings were consistent with previous FAc implant studies. 0 0 0 0