Is higher dose, less frequent administration of aflibercept feasible for nAMD?
A pooled analysis indicated the feasibility of administering a higher dosage of aflibercept in patients with neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) without an increase in safety concerns. The findings were presented at the 2024 ARVO Annual Meeting in Seattle, Washington.
The analysis compared the outcomes of aflibercept 8 mg versus 2 mg in patients enrolled in the following 3 trials:
- CANDELA: A single-masked, open-label, 44-week, phase 2 trial in which treatment-naïve patients with nAMD were randomized 1:1 to receive 3 monthly doses of aflibercept 8 mg or 2 mg plus additional doses at weeks 20 and 32
- PHOTON: A double-masked, 98-week, non-inferiority, phase 2/3 trial that included DME patients who were randomized 1:2:1 to receive aflibercept 2 mg every 8 weeks after 5 monthly doses or 8 mg every 12 or 16 weeks after 3 monthly doses
- PULSAR: A double-masked, 96-week, non-inferiority, phase 3 trial that randomized nAMD patients 1:1:1 to receive aflibercept 2 mg every 8 weeks or 8 mg every 12 or 16 weeks after 3 monthly doses
The total patient cohort comprised 1,773 patients: 1,217 treated with aflibercept 8 mg and 556 treated with aflibercept 2 mg. The researchers determined that the safety was “comparable” between the 2 dosing regimens (8 vs 2 mg).
Treatment-related ocular adverse events (AEs) occurred in 47.9% of patients receiving the 8-mg dose and 47.3% of patients receiving the 2-mg dose.
The most commonly occurring AEs in the 8- and 2-mg cohorts were cataracts (8.2% and 5.0%), reduced visual acuity (4.4% and 5.4%), vitreous floaters (4.0% and 4.0%), conjunctival hemorrhage (3.8% and 3.1%), and retinal hemorrhage (3.6% and 4.0%).
Serious AEs occurred in 2.3% and 1.3% of patients treated with aflibercept 8 mg and 2 mg, respectively.
“These findings suggest there is no increase in side effects after aflibercept 8 mg compared with aflibercept 2 mg,” the authors explained of their research.
Reference
Stahl A, Schneider E, Schmidt-Ott UM, et al. Pooled safety analysis of the CANDELA, PHOTON, and PULSAR trials up to 96 weeks demonstrates comparable safety profiles with aflibercept 8 mg and 2 mg. Abstract 217-B0280. Presented at the Association for Research in Vision and Ophthalmology 2024 Annual Meeting, May 5-9, Seattle, Washington.
