On Tuesday, Regeneron Prescribed drugs, Inc. REGN introduced the first endpoint was met within the Section 3 QUASAR trial investigating EYLEA HD (aflibercept) Injection 8 mg for the therapy of sufferers with macular edema following retinal vein occlusion (RVO)
RVO is a blockage in one of many veins within the retina, the light-sensitive tissue in the back of the attention.
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Within the trial, sufferers handled with EYLEA HD each 8 weeks (after preliminary month-to-month doses) skilled non-inferior imaginative and prescient positive aspects in comparison with these handled with the authorized month-to-month dosing routine of EYLEA (aflibercept) Injection 2 mg, the present normal of care.
These knowledge might be submitted to regulatory authorities world wide, with a submission to the FDA deliberate for the primary quarter of 2025.
The protection profile of EYLEA HD (n=591) was just like EYLEA (n=301) in QUASAR and remained usually in line with its identified security profile of EYLEA HD in pivotal trials.
EYLEA HD (often called Eylea 8 mg within the European Union and Japan) is being collectively developed by Regeneron and Bayer AG BAYRY.
Within the U.S., Regeneron maintains unique rights to EYLEA and EYLEA HD. Bayer has licensed unique advertising and marketing rights exterior of the U.S., the place the businesses share equally the earnings from EYLEA and EYLEA HD gross sales.
Final 12 months, the FDA authorized Eylea HD (aflibercept) Injection 8 mg for moist age-related macular degeneration, diabetic macular edema, and diabetic retinopathy (DR).
Third quarter 2024 U.S. web gross sales for Eylea HD and Eylea elevated 3% versus third quarter 2023 to $1.54 billion, together with $392 million from Eylea HD.
Worth Motion: REGN inventory is up 2.04% at $739.64 on the final verify on Tuesday.
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