Patients Maintain Longer Breaks Between Treatment with Improvements in Fluid Levels

Patients with treatment-naïve neovascular age-related macular degeneration (AMD) who experienced improvements in their eye fluid after initial treatment could take the medication aflibercept less frequently, with many maintaining longer treatment intervals, according to a new study. The study, presented at 127th Annual American Academy of Ophthalmology (AAO) Congress in San Francisco, California, showed that with longer treatment intervals, visual gains and safety of aflibercept 8 mg remained consistent.¹

Led by Varun Chaudhary, MD, of McMaster University in Hamilton, Canada, PULSAR, an ongoing, double-masked, 96-week trial, randomized patients with treatment-naïve neovascular AMD, broke participants into 3 groups. One group received 8 mg of aflibercept every 12 weeks, another group also received 8 mg but every 16 weeks, and the third group received only 2 mg every 8 weeks. All participants received 3 monthly injections. The investigators analyzed the presence of eye fluid at weeks 4, 8, and 12.

In the group who received 8 mg every 12 weeks (n = 312), 89.7% participants in week 4, 89.9% in week 8, and 88.4% in week 12 continued their treatment schedule and took the medication at least by 12-week mark.

Meanwhile, 80.4% in week 4, 81.4% in week 8, 79.8% in week 12 who had fluid resolution were able to continue their treatment schedule with 16-week intervals between treatments until the 48-week mark of the study. Though, 16.1% (n = 50/ 312) never completed fluid resolution at either week 4, 8, or 12.

Out of these 50 patients who did not complete their fluid resolution, 80% of the 50 patients were able to maintain a treatment schedule with at least 12-week intervals between their treatments and 66% maintained a treatment schedule with 16-week intervals between their treatments. Thus, while a significant portion of patients did not have a complete fluid resolution, they could still receive their treatments with extended intervals, either every 12 or 16 weeks.

Overall, 80% – 90% of patients continued their treatments at intervals of either > 12 weeks or 16 weeks between each injection until week 48.

“It is great to see aflibercept 8 mg deliver another set of exciting results,” said Charles C. Wykoff, MD, PhD, director of research at retina consultants of Texas and a trial investigator, in a Regeneron news release. “In the PULSAR trial, aflibercept 8 mg achieved impressive durability, while importantly maintaining visual acuity gains from year one through year two…If approved by regulatory authorities, aflibercept 8 mg has the potential to become the new standard of care for diabetic macular edema and wet age-related macular degeneration.”²

References

1. Chaudhary, V, Zarranz-Ventura J, Leal, S, Machewitz, T, et al. Early Fluid Resolution Association With Treatment Interval Maintenance at Week 48 in Patients Receiving Aflibercept 8 mg: Phase 3 PULSAR Trial. Presented at the 2023 American Academy of Ophthalmology Annual Meeting, November 3 – 6, 2023.
2. Early Fluid Resolution Association with Treatment Interval Maintenance at Week 48 in Patients Receiving Aflibercept 8 mg: Phase 3 PULSAR Trial. American Academy of Ophthalmology. 2023.