PULSAR study: less frequent injections for neovascular AMD may be possible
The phase 3 PULSAR study indicated that a higher dose of aflibercept (8 mg) can result in similar safety and efficacy outcomes as the standard lower treatment dose (2 mg). This higher-dose option can reduce the frequency of treatment injections for patients with neovascular age-related macular degeneration (nAMD). The findings were presented at the 2024 ARVO Annual Meeting in Seattle, Washington.
The double-masked, 96-week study randomized patients 1:1:1 to 3 treatment cohorts, each after receiving 3 initial monthly injections:
- Aflibercept 2 mg every 8 weeks
- Aflibercept 8 mg every 12 weeks
- Aflibercept 8 mg every 16 weeks
Change in best corrected visual acuity from baseline at week 96 was +6.6 for aflibercept 2 mg every 8 weeks, +5.6 for aflibercept 8 mg every 12 weeks, and +5.5 for aflibercept 8 mg every 16 weeks. Among those treated with the higher dose regimen, 75% in the 12-week and 70% in the 16-week dosing cohorts who completed 96 weeks of treatment maintained their ³12- and ³16-week dosing intervals.
The researchers reported no new safety signals with aflibercept 8 mg compared with 2 mg.
Among those in the 8-mg dosing cohort who completed 96 weeks of treatment, 47% had dosing intervals of ³20 weeks and 28% had a 24-week dosing interval.
“These findings suggest that aflibercept 8 mg may reduce the need for frequent injections in people with wet AMD,” the authors concluded.
Reference
Sivaprasad S, Korobelnik JF. BCVA gains with aflibercept 8 mg maintained through Week 96 in PULSAR with extended treatment intervals in patients with nAMD. Abstract 2115. Presented at the Association for Research in Vision and Ophthalmology 2024 Annual Meeting, May 5-9, Seattle, Washington.
