Name

Injections intravitréennes d'aflibercept 8 mg chez des patients atteints de dégénérescence maculaire néovasculaire liée à l'âge: Résultats à 48 semaines de l'essai de Phase 3 PULSAR

Anatomic and visual improvements with intravitreal aflibercept 8 mg in CANDELA (Phase 2) suggested potential additional benefit over intravitreal aflibercept 2 mg in patients with neovascular age-related macular degeneration (nAMD). The Phase 3 PULSAR 96-week trial evaluates the efficacy and safety of intravitreal aflibercept 8 mg injection administered every 12 (8q12) or 16 weeks (8q16) versus intravitreal aflibercept 2 mg every 8 weeks (2q8), each after three initial monthly injections in patients with treatment-naïve nAMD. 

PULSAR (NCT04423718) is an ongoing, double-masked, 96-week, Phase 3 trial: patients aged ≥50 years with nAMD were randomly assigned 1:1:1 to receive 8q12, 8q16 or 2q8. Primary endpoint was best-corrected visual acuity (BCVA) change from baseline at Week 48 (non-inferiority margin at 4 letters). The key secondary endpoint was proportion of patients with no intraretinal/subretinal fluid (IRF/SRF) in central subfield at Week 16 and other secondary endpoints included safety. Exploratory endpoints included the proportion of patients with ≥12-week and 16-week treatment intervals through Week 48.

Overall, 1,009 patients (8q12: n=335; 8q16: n=338; 2q8: n=336) were evaluated (mean±SD age 74.5±8.4 years, 54.5% female). The primary endpoint was met with intravitreal aflibercept 8 mg (8q12 vs. 2q8: p=0.0009; 8q16 vs. 2q8: p=0.0011). Observed mean (±SD) change from baseline in BCVA at Week 48 was +6.7±12.6 (baseline: 59.9±13.4), +6.2±11.7 (baseline: 60.0±12.4), and +7.6±12.2 letters (baseline: 58.9±14.0) with 8q12, 8q16, and 2q8, respectively. In the 8q12 group (n=316), 79% of patients maintained 12-week treatment intervals, and 77% of patients in the 8q16 group (n=312) maintained 16-week treatment intervals in Year 1. Overall, 83% of patients receiving intravitreal aflibercept 8 mg (n=628) maintained ≥12-week treatment intervals in Year 1. Intravitreal aflibercept 8 mg demonstrated superior drying versus intravitreal aflibercept 2 mg at Week 16; 63% versus 52% of patients, respectively, had no IRF/SRF in central subfield (p=0.0002). The safety of intravitreal aflibercept 8 mg was similar to the safety profile of intravitreal aflibercept 2 mg.

Intravitreal aflibercept 8 mg met the primary efficacy endpoint in nAMD, demonstrating non-inferiority in BCVA versus intravitreal aflibercept 2 mg, with no new safety signals through 48 weeks. The vast majority of patients maintained extended ≥12-week dosing (83% in the 8 mg groups combined) and 16-week dosing (77% in the 8q16 group).

Overall, intravitreal aflibercept 8 mg provides greater therapeutic benefit, an expanded injection interval, and equivalent safety versus intravitreal aflibercept 2 mg.

This abstract is presented on behalf of the PULSAR study investigators.