(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN), announced that the FDA has approved EYLEA HD for adult patients with macular edema following retinal vein occlusion.
The approval also added a monthly dosing option across all previously approved indications, including wet age-related macular degeneration (wAMD), diabetic macular edema (DME), diabetic retinopathy (DR) and RVO.
EYLEA HD (aflibercept injection 8 mg) is the first FDA-approved treatment for RVO that allows dosing every eight weeks after an initial monthly period, potentially reducing the number of injections compared to existing therapies.
At the same time, the FDA approved a monthly (every 4-week) dosing option, which provides physicians with greater flexibility to tailor treatment schedules to individual patient needs.
Retinal vein occlusion is one of the most common retinal vascular disorders. Globally, RVO affects more than 28 million people.
The approval is supported by the data from the Phase 3 QUASAR trial, which evaluated EYLEA HD against EYLEA (aflibercept injection 2 mg) in patients with RVO. At 36 weeks, patients receiving EYLEA HD every eight weeks achieved non-inferior visual acuity gains compared to those treated with EYLEA every four weeks. Results were consistent across branch, central and hemiretinal vein occlusions.
The QUASAR study is being conducted by Bayer under a collaboration agreement with Regeneron.
In RVO, the most common adverse reactions (=3%) reported with EYLEA HD included increased intraocular pressure, blurred vision, cataract, conjunctival hemorrhage, ocular discomfort, and vitreous detachment.
Last month, the company's supplemental BLA for EYLEA HD pre-filled syringe formulation was turned down by the FDA due to unresolved inspection findings at Catalent Indiana, LLC, the manufacturing filler.
Regeneron plans a new BLA submission in January 2026 to include an alternate pre-filled syringe manufacturing filler.
EYLEA HD's U.S. net sales rose 10% year-over-year to $431 million in the third quarter of 2025, compared to $392 million in the same period. However, the combined EYLEA HD and EYLEA U.S. net sales fell 28% to $1.11 billion, reflecting ongoing competitive pressures and patient shifts to EYLEA HD.
REGN has traded in the range of $476.49 to $800.99 over the past year. The stock closed yesterday's trading at $702.75, down 3.11%, before rising to $725, in after-hours trading, up 3.17%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
