On Tuesday, Regeneron Pharmaceuticals, Inc. REGN announced the primary endpoint was met in the Phase 3 QUASAR trial investigating EYLEA HD (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO)
RVO is a blockage in one of the veins in the retina, the light-sensitive tissue at the back of the eye.
In the trial, patients treated with EYLEA HD every 8 weeks (after initial monthly doses) experienced non-inferior vision gains compared to those treated with the approved monthly dosing regimen of EYLEA (aflibercept) Injection 2 mg, the current standard of care.
These data will be submitted to regulatory authorities around the world, with a submission to the FDA planned for the first quarter of 2025.
The safety profile of EYLEA HD (n=591) was similar to EYLEA (n=301) in QUASAR and remained generally consistent with its known safety profile of EYLEA HD in pivotal trials.
EYLEA HD (known as Eylea 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG BAYRY.
In the U.S., Regeneron maintains exclusive rights to EYLEA and EYLEA HD. Bayer has licensed exclusive marketing rights outside of the U.S., where the companies share equally the profits from EYLEA and EYLEA HD sales.
Last year, the FDA approved Eylea HD (aflibercept) Injection 8 mg for wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy (DR).
Third quarter 2024 U.S. net sales for Eylea HD and Eylea increased 3% versus third quarter 2023 to $1.54 billion, including $392 million from Eylea HD.
Price Action: REGN stock is up 2.04% at $739.64 at the last check on Tuesday.
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