Post hoc analysis of PULSAR data shows sustained fluid control with Eylea HD
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BARCELONA, Spain — A post hoc analysis of PULSAR trial data showed sustained fluid control at 2 years with fewer injections and longer dosing intervals in patients treated with aflibercept 8 mg for wet age-related macular degeneration.
“We also saw higher proportions of patients with fluid resolution observed with 8 mg vs. 2 mg when we assessed fluid 8 weeks after each active matched injection, starting from the third injection,” Praveen J. Patel, MBBChir, MA, FRCOphth, MD(Res), said at the Euretina congress.
The trial met its primary outcome at week 48. Eylea HD (aflibercept 8 mg, Regeneron) demonstrated noninferior visual acuity gains with extended dosing intervals — every 12 weeks and every 16 weeks — compared with Eylea (aflibercept 2 mg, Regeneron) every 8 weeks in patients with neovascular AMD, with no new safety signals. Rapid and sustained reduction in central retinal thickness was also observed.
“One of the key secondary outcomes was to look at the proportion of patients with absence of fluid in the central subfield 8 weeks after the end of the loading phase at week 16. Here we see a statistically significant difference, with a greater proportion of patients randomized to 8 mg achieving this compared to 2 mg,” Patel said. “Moving forward in time and looking at the duration of the study, we see comparable proportions of patients in the 8 mg groups compared to the 2 mg groups achieving absence of fluid or dry macula both at week 48 and week 96.”
These benefits were observed regardless of disease severity or patients’ baseline characteristics, including best corrected visual acuity and central retinal thickness, and regardless of whether the lesion was classified as minimally classic, occult only or predominantly classic at baseline.
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Patel PJ, et al. A 96-week PULSAR phase 3 trial post-hoc analysis: Rapid and sustained fluid control with aflibercept 8mg every 12 weeks or longer, as defined by fluid-free status at weeks 16, 48, and 96 stratified by baseline CRT and BCVA. Presented at: Euretina congress; Sept. 19-22, 2024; Barcelona, Spain.
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