26doc135 10.3205/26doc135 urn:nbn:de:0183-26doc1359 Meeting Abstract Khoramnia Khoramnia Ramin R

University Eye Clinic Heidelberg, Heidelberg

author Hariprasad Hariprasad Seenu M. SM

The University of Chicago, Department of Ophthalmology and Visual Science, Chicago, USA

author Chaudhary Chaudhary Varun V

St Joseph’s Healthcare Hamilton, McMaster University, Hamilton Regional Eye Institute, Hamilton, Kanada

author Chen Chen Youxin Y

Peking Union Medical College Hospital, Beijing, China

author Chang Chang Andrew A

Sydney Retina Clinic, Sydney, Australien

author Kamei Kamei Motohiro M

Aichi Medical University, Department of Ophthalmology, Aichi, Japan

author Leal Leal Sergio S

Bayer Consumer Care AG, Basel, Schweiz

author Niesen Niesen Tobias T

Bayer AG, Leverkusen

author Gilbert Gilbert Rose R

Bayer Consumer Care AG, Basel, Schweiz

author Pryds Pryds Anders A

Bayer AG, Copenhagen, Dänemark

author Schlief Schlief Sarah S

Bayer AG, Berlin

author Mendolia Mendolia Franco F

Bayer AG, Wuppertal

author Hasanbasic Hasanbasic Zoran Z

Bayer Consumer Care AG, Basel, Schweiz

author Berliner Berliner Alyson J. AJ

Regeneron Pharmaceuticals, Inc., Tarrytown, USA

author Athanikar Athanikar Aditya A

Regeneron Pharmaceuticals, Inc., Tarrytown, USA

author Silva Silva Fabiana Q. FQ

Regeneron Pharmaceuticals, Inc., Tarrytown, USA

author Gale Gale Richard R

Hull York Medical School, University of York, York, Vereinigtes Königreich

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 135 38. Internationaler Kongress der Deutschen Ophthalmochirurgie (DOC) Retina Nürnberg 20260618 20260620 EPO 6.4 TextPurpose: To evaluate the efficacy and safety of aflibercept 8 mg versus 2 mg in patients with treatment-naïve macular edema following retinal vein occlusion (MEfRVO). Methods: QUASAR (NCT05850520) was a 64-week, randomized, double-masked, active-controlled, noninferiority, Phase 3 trial of patients aged ≥18 years with MEfRVO, enrolled in 27 countries across Europe, America, Japan, and the Asia Pacific region. Patients were assigned 1:1:1 to aflibercept 8 mg every 8 weeks (wks), after 3 (8q8/3 [n=293]) or 5 (8q8/5 [n=298]) initial monthly doses, or aflibercept 2 mg every 4 wks (2q4 [n=301]). Patients who met prespecified criteria could have their dosing intervals shortened if their last dosing interval was >4 weeks, or extended by 4 weeks starting at Week 32 for 8q8/3 and 2q4 and at Week 40 for 8q8/5. The minimum dosing interval was every 4 weeks (Q4). The primary endpoint was best-corrected visual acuity (BCVA) change from baseline (BL) to Week 36. Key secondary endpoint was number of injections from BL to Week 64. Results: Aflibercept 8 mg showed robust and non-inferior BCVA gains versus 2 mg, with least squares (LS) mean difference (2-sided 95% CI) in BCVA versus 2q4 at W36 of -0.1 (-2.0, 1.9) letters for 8q8/3 and +0.8 (-1.1, 2.7) letters for 8q8/5 (both p<0.0001, 4-letter non-inferiority margin). At Week 64, up to 3 fewer injections of aflibercept 8 mg versus 2 mg were administered, the LS mean difference (2-sided 95% CI) in number of injections versus 2q4 was -3.2 (-3.5, -3.0) and -2.2 (-2.4, -2.0) for 8q8/3 and 8q8/5, respectively. At Week 64, 81.4% (8q8/3) and 78.5% (8q8/5) versus 67.8% (2q4) had a last completed dosing interval of ≥Q12; and 40.5% of the 8q8/3 group were assigned to Q20 intervals. Nearly 3-fold fewer patients were assigned a Q4 dosing interval with 8q8/3 and 8q8/5 versus 2q4 at W64 (4.8% & 3.5% vs 13.0%). The aflibercept 8 mg safety profile was consistent with the established safety profile of aflibercept 2 mg in patients with MEfRVO. Representative case studies will be presented to substantiate the reported findings. Conclusions: In patients with MEfRVO, aflibercept 8 mg met the primary and key secondary endpoints demonstrating non-inferiority in BCVA gains at Week 36, which were maintained through Week 64 with up to 3 fewer injections compared with aflibercept 2 mg. More patients treated with aflibercept 8 mg achieved every 12 weeks or greater dosing intervals, fewer required monthly intervals, and up to 41% of the 8q8/3 group qualified for every 5 month intervals. Overall, aflibercept 8 mg provided robust visual outcomes with fewer injections, and with a comparable safety profile to aflibercept 2 mg. 0 0 0 0