FDA Approves Expanded Dosing Intervals for Regeneron's EYLEA HD

The U.S. Food and Drug Administration (FDA) has approved a label expansion for Regeneron's EYLEA HD (aflibercept) 8 mg injection, allowing for dosing intervals of up to every 20 weeks. This approval targets patients with wet age-related macular degeneration (AMD) and diabetic macular edema (DME), supported by 96-week clinical data from the PULSAR and PHOTON trials. Strategically, the Eylea HD expansion is specifically aimed at offsetting the declining sales of the original Eylea 2 mg product. By offering a less frequent dosing schedule, Regeneron gains a significant competitive advantage in patient convenience over standard treatments. This move is expected to strengthen the company's market position against rivals such as Roche's Vabysmo. Ultimately, the transition to the HD version is a key part of Regeneron's strategy to mitigate revenue losses and support the long-term potential of the EYLEA franchise.