Regeneron announces FDA approval of extension of dosing intervals for EYLEA HD

Regeneron (REGN) Pharmaceuticals announced that the U.S. Food and Drug Administration has approved the extension of dosing intervals for EYLEA HD up to every 20 weeks for patients with wet age-related macular degeneration and diabetic macular edema following one year of successful response based on visual and anatomic outcomes. As part of the approval, the FDA has updated the EYLEA HD label to include 96-week data from the pivotal PULSAR trial in wAMD and the pivotal PHOTON trial in DME, demonstrating sustained efficacy and safety through 2 years with extended dosing intervals. With this latest approval, dosing with EYLEA HD can now be individualized for patients with wAMD and DME, some of whom may need treatment as frequently as every 4 weeks, as well as those who can successfully be extended to treatment as infrequently as every 20 weeks, based on criteria described in the U.S. Prescribing Information. This further extends the widest range of dosing intervals of any approved injectable anti-VEGF.