The objective of the Phase 3 PULSAR trial was to assess the efficacy and safety of intravitreal aflibercept 8 mg injection at different intervals (8q12 or 8q16) compared to the standard aflibercept 2 mg every 8 weeks (2q8) in treatment-naïve patients with neovascular age-related macular degeneration (nAMD). With 1,009 patients enrolled in the study, the primary endpoint was the change in best-corrected visual acuity (BCVA) from baseline at Week 48, with a non-inferiority margin set at 4 letters.
The results demonstrated that aflibercept 8 mg successfully met the primary efficacy endpoint, showing non-inferiority in BCVA improvement compared to aflibercept 2 mg. The observed mean BCVA improvements were +6.7 letters (8q12), +6.2 letters (8q16), and +7.6 letters (2q8). Furthermore, the safety profile of aflibercept 8 mg was similar to aflibercept 2 mg, with no new safety signals observed through Week 48.
A significant finding was the ability of aflibercept 8 mg to provide superior drying effects compared to the standard dose. At Week 16, 63% of patients receiving aflibercept 8 mg had no intraretinal/subretinal fluid (IRF/SRF) in the central subfield, whereas only 52% of patients receiving aflibercept 2 mg achieved the same outcome.
Moreover, aflibercept 8 mg exhibited a remarkable extended injection interval, with 79% of patients in the 8q12 group and 77% in the 8q16 group maintaining 12-week and 16-week treatment intervals, respectively, in Year 1. Overall, 83% of patients receiving aflibercept 8 mg maintained an injection interval of ≥12 weeks in Year 1.
The PULSAR trial demonstrates that aflibercept 8 mg offers comparable safety and non-inferior efficacy in terms of BCVA improvement compared to aflibercept 2 mg. The extended injection interval, combined with its superior drying effects, makes aflibercept 8 mg a promising treatment option for patients with nAMD, potentially reducing the treatment burden and improving visual outcomes.
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