FDA approves aflibercept 8mg for nAMD, DME, and DR
The U.S. Food and Drug Administration has approved aflibercept (Eylea) HD Injection 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR).
The recommended dose for aflibercept is 8 mg (0.07 mL of 114.3 mg/mL solution) every 4 weeks (monthly) for the first 3 months across all indications, followed by 8 mg every 8 to 16 weeks (2 to 4 months) in nAMD and DME and every 8 to 12 weeks (2 to 3 months) for DR.
The FDA approval is based on the results of the PULSAR and PHOTON trials that evaluated the effectiveness of aflibercept HD compared to aflibercept 2 mg in treating nAMD and DME over a 48-week period. In the PULSAR trial involving nAMD patients (n = 1009) and the PHOTON trial involving DME patients (n = 658), the primary objectives were met. Aflibercept HD demonstrated vision gains that were non-inferior and clinically equivalent to the gains achieved by aflibercept 2 mg. The study found that aflibercept HD’s dosing regimens of 12 and 16 weeks, following just 3 initial monthly doses, produced similar vision improvements compared to aflibercept’s 8-week dosing regimen after an initial series of monthly doses (3 in PULSAR and 5 in PHOTON).
Most patients who were initially assigned to aflibercept HD’s 12- or 16-week dosing regimens were able to maintain these intervals throughout the 48-week duration of the trials. This approval indicates that aflibercept HD is a promising treatment option for both nAMD and DME patients.
Read the full press release here.
