Overview
- Eylea HD won U.S. approval to treat macular edema following retinal vein occlusion with dosing up to every eight weeks after an initial monthly period, making it the only drug with that schedule for RVO.
- The FDA also added an every-four-week option across all approved Eylea HD indications, giving physicians formal flexibility for patients who need more frequent dosing.
- The decisions were supported by Phase III QUASAR data showing non-inferiority to standard-dose Eylea in visual acuity gains for RVO patients.
- A pre-filled syringe version remains unapproved following an October FDA rejection tied to issues at Catalent Indiana, and Regeneron plans to file for an alternate syringe filler by January.
- Regeneron reported $1.1 billion in U.S. Eylea sales in Q3 2025, up 28% year over year, and analysts at Citi called the new approvals a positive catalyst that could drive an inflection as early as Q1 2026.