FDA Approves New Indication and Monthly Dosing for Regeneron’s Eylea HD

The FDA has approved two new uses for Regeneron's Eylea HD (aflibercept) 8 mg injection:
treatment of macular edema following retinal vein occlusion (RVO), and a new monthly dosing option for all approved indications1 3 5 9 11.

Eylea HD is now the first therapy for RVO that allows dosing every eight weeks after an initial period of monthly injections, potentially cutting required injections in half compared to previous therapies1 5 6.

The label expansion permits Eylea HD to be administered every four weeks (monthly) across all its current indications, giving physicians more flexibility in tailoring treatment schedules1 3 5 7.

FDA approval for these new uses was based on data from the Phase III QUASAR trial, which showed non-inferior visual acuity gains for Eylea HD compared to the original Eylea when using less frequent dosing3 6.

Eylea HD was previously approved for wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR)1 10.

Regeneron is still seeking FDA clearance for easier-to-use pre-filled syringes of Eylea HD; the approval process has been delayed due to manufacturing concerns1 8.

This expanded approval strengthens Regeneron's competitive position in the retinal disease market, especially against Roche's Vabysmo, which previously offered less frequent dosing1.