Abstract
Purpose :
In the PULSAR (NCT04423718) double-masked, 96-week (wk), Phase 3 trial in patients with neovascular age-related macular degeneration (nAMD), aflibercept 8 mg every 12 wks (8q12) and every 16 wks (8q16) demonstrated non-inferior (NI) gains versus aflibercept 2 mg every 8 wks (2q8) in best-corrected visual acuity (BCVA; NI margin of 4 letters) from baseline at Wk 48 (primary endpoint). Evaluation of the primary endpoint in a subpopulation of Asian patients was pre-specified at Wk 48 and evaluated through Wk 96 in a post hoc analysis.
Methods :
Patients were randomized 1:1:1 to receive aflibercept 8q12, 8q16, or 2q8, each after 3 monthly injections. Dosing intervals for patients in the aflibercept 8q12 and 8q16 groups could be shortened from Wk 16 and extended from Wk 52 based on protocol criteria. Outcomes for Asian patients were assessed at Wks 48, 60, and 96 using a last observation carried forward approach.
Results :
Of 1009 patients treated, 234 patients were Asian (8q12: n=74; 8q16: n=77; 2q8: n=83; and baseline BCVA [±SD]: 57.7±13.9, 58.1±12.2, and 59.2±14.1 letters, respectively). At Wk 48, aflibercept 8q12 and 8q16 groups demonstrated comparable BCVA gains to 2q8 in Asian patients, with mean (95%CI) BCVA gains from baseline of 9.3 (5.7, 12.9), 8.8 (6.8, 10.8), and 7.5 (4.7, 10.3) letters, in the 8q12, 8q16 and 2q8 groups, respectively. At Wk 60, mean (95%CI) BCVA gains from baseline were 9.4 (5.8, 13.1), 8.7 (6.7, 10.7), and 8.2 (5.4, 11.0) letters, respectively, and at Wk 96 were 8.9 (5.1, 12.8), 7.2 (4.8, 9.6) and 7.5 (4.8, 10.3) letters, respectively. At Wk 96, 90% (8q12) and 84% (8q16) of Asian patients were assigned dosing intervals ≥12 and ≥16 wks, respectively; 55% of patients receiving aflibercept 8 mg had treatment intervals extended to ≥20 wks and 33% to 24 wks. Aflibercept 8 mg and 2 mg had similar safety profiles in the Asian subpopulation.
Conclusions :
In Asian patients with nAMD, consistent with the overall population, aflibercept 8 mg demonstrated comparable BCVA gains at Wk 48 versus aflibercept 2 mg, and these gains were maintained with fewer injections and no new safety signals through Wk 96.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.