The FDA approved Eylea HD, an 8 mg aflibercept injection, to treat wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy, according to a press release from Regeneron.
The approval was based on 48-week results from the pivotal PULSAR trial in wet AMD and PHOTON trial in DME, which compared Eylea HD 8 mg and Eylea 2 mg. Both trials met their primary endpoints, with Eylea HD showing noninferior and clinically equivalent vision gains with 12- and 16-week regimens after three initial monthly doses compared with an 8-week dosing (Read more...)