Abstract
Purpose :
To evaluate aflibercept 8 mg vs aflibercept 2 mg in patients with treatment-naïve neovascular age-related macular degeneration (nAMD).
Methods :
PULSAR (NCT04423718) is a double-masked, 96-week, Phase 3 trial. Patients were randomly assigned 1:1:1 to receive aflibercept 8 mg every 12 or 16 weeks (8q12 [n=335] or 8q16 [n=338]) or aflibercept 2 mg every 8 weeks (2q8 [n=336]), each after three initial monthly injections. The dosing regimens for patients in the aflibercept 8q12 and aflibercept 8q16 groups could be shortened from Week 16 and extended from Week 52 based on protocol criteria.
Results :
Least squares mean (SE) change in best-corrected visual acuity (BCVA) from baseline at Week 96 (exploratory endpoint) was +6.6 (0.73), +5.6 (0.77), and +5.5 (0.75) Early Treatment Diabetic Retinopathy Study letters with aflibercept 2q8, 8q12, and 8q16, respectively (non-inferiority test at 4-letter margin, 8q12 vs 2q8: p=0.0006; 8q16 vs 2q8: p=0.0007 [p values are nominal]). Through Week 96, 75% (8q12) and 70% (8q16) of patients who completed 96 weeks maintained ≥12- and ≥16-week dosing intervals. In the combined aflibercept 8 mg arm, 47% of patients who completed 96 weeks had dosing intervals of ≥20 weeks at Week 96; 28% had a 24-week dosing interval at Week 96. No new safety signals were identified with aflibercept 8 mg.
Conclusions :
Through Week 96, aflibercept 8 mg every ≥12 weeks maintained similar BCVA gains and had a similar safety profile compared with aflibercept 2 mg every 8 weeks in patients with nAMD. At Week 96, almost half of all patients in the combined aflibercept 8 mg arm who completed 96 weeks of treatment qualified for extended dosing intervals of ≥20 weeks.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.