On August 18, 2023, the U.S. Food and Drug Administration (FDA) approved Eylea HD (aflibercept), a high-dose version of Eylea, for the treatment of several retinal conditions, including advanced neovascular age-related macular degeneration (wet AMD), diabetic macular edema (DME), and diabetic retinopathy (DR). Texas Retina began treating patients with Eylea HD in October, providing patients the opportunity to maintain vision gains with fewer injections compared to Eylea.
Aflibercept is an anti–vascular endothelial growth factor agent designed to block the growth of new blood vessels and prevent fluid from passing through blood vessels in the eye. The FDA approved the original Eylea product, a 2 mg monthly intravitreal injection, in 2011. Eylea HD is a higher dose, longer acting formulation. The recommended dose for Eylea HD is 8 mg every 4 weeks for the first 3 months across all indications, followed by every 8 to 16 weeks for wet AMD or DME and every 8 to 12 weeks for DR.
FDA approval of Eylea HD was granted based on the 48-week results of the PULSAR and PHOTON clinical trials, which compared its safety and effectiveness to Eylea Injection 2 mg. The PULSAR trial enrolled patients with wet AMD, and the PHOTON trial focused on DME patients. Both studies demonstrated clinically equivalent vision gains at 48 weeks with the extended dosing intervals provided by Eylea HD.