Aflibercept 8 mg Provides Better Outcomes Than The 2 mg Dose in PULSAR Study

Credit: of Bordeaux University Hospital

The PULSAR study found that aflibercept 8 mg provides better anatomical and functional outcomes compared to the 2 mg dosage for patients for patients with wet age-related macular degeneration (AMD). On 8 mg, patients were able to extend the dosing interval.1

Jean-Francois Korobelnik, MD, of Bordeaux University Hospital presented the 2-year PULSAR study in a session called “aflibercept 8 mg in patients with neovascular AMD: Phase 3 PULSAR Trial 96-Week Results” on November 3rd at 127th Annual American Academy of Ophthalmology (AAO) conference in San Francisco, California. Korobelnik. PULSAR was a randomized multicenter, double-masked, active-control pivotal study of 1,000 patients that compared aflibercept 2 mg every 6 weeks, 8 mg every 12 weeks, and 8 mg every 16 weeks, with a primary endpoint at 1 year with the option for another year extension. The study concluded in 2 years. The investigators specifically examined aflibercept 8 mg of aflibercept versus 2 mg.

The study had a good retention rate. At the 2-year mark, there were about 85% of patients that stayed in the trial. For patients who received 8 mg, 89.7% of participants in week 4 continued their treatment schedule, 89.9% did in week 8, and 88.4% did in week 12. Also, 80.4% in week 4, 81.4% in week 8, 79.8% in week 12 who had fluid resolution maintained their treatment schedule with 16-week intervals between treatments until the 48-week mark of the study.2 BCDA baseline did well with roughly 59 and 60 letters.

“At one year, three groups were very much comparable [in BCVA changes],” Korobelnik said. “[At] two years, you see that it remains completely stable flat in the three group…these differences were reached the non-inferiority statistic criteria with the fall into March.

Korobelnik said 8 mg received great results by 2 years. Over half (78%) of patients randomized to Q16 maintained Q16, and 53% reached at least Q28. Also, a colleague Korobelnik noted they did not find side effects in preclinical studies.

“I think we're going to look and see with the clinical data, what we see,” the colleague said. “But what was really encouraging in terms of side effects in this study was this is the first blocking of complement that we did not see increase C and D rates on the 12 [months]… it's the first one that we don't see effects on lesion growth, but we do see what we've been wanting to see, which is the effects on visual function at a pretty short time-period of only 12 months.”

References

1. ^{Korobelnik, J. Aflibercept 8 mg in Patients with Neovascular AMD: Phase 3 PULSAR Trial 96-Week Results. Presented at the 2023 American Academy of Ophthalmology Annual Meeting; November 3, 2023; California, San Francisco.}
2. ^{Derman, C. Patients Maintain Longer Breaks Between Treatment with Improvements in Fluid Levels. 2023. Accessed November 2023. https://www.hcplive.com/view/patients-maintain-longer-breaks-between-treatment-with-improvements-in-fluid-levels-study-finds.}