FDA Grants Regeneron Two Eylea HD Approvals in One Day

On November 19, 2025, the FDA approved Regeneron's Eylea HD (aflibercept 8 mg) for two new uses:
treatment of macular edema following retinal vein occlusion (RVO), and monthly (every four-week) dosing across all approved indications1 3 6 7 9.

Eylea HD is the only drug that can be administered every eight weeks (after an initial period of monthly dosing) for RVO, providing a more flexible dosing schedule for physicians and patients1 3.

The approvals position Eylea HD as a stronger competitor against Roche’s Vabysmo, which had an advantage due to less frequent dosing1 3.

These new approvals are expected to help Regeneron maintain and expand its market position in the eye disease sector, as Eylea HD is a critical revenue driver for the company1 3.

Sales of Eylea (including HD) reached $1.1 billion in the US in Q3 2025, up 28% from the previous year, reflecting the importance of these regulatory wins to Regeneron's business3.

Despite these label expansions, the FDA has not yet approved the pre-filled syringe formulation of Eylea HD due to ongoing manufacturing issues at a Novo Nordisk plant, although Regeneron plans to resubmit with an alternate manufacturer in January 20262 3 4 5.