Regeneron's Best-Selling Eye Drug Eylea's Higher Dose Formulation Meets Primary Goal In Another Form Of Retinal Disease Study
Regeneron's Best-Selling Eye Drug Eylea's Higher Dose Formulation Meets Primary Goal In Another Form Of Retinal Disease Study
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.On Tuesday, Regeneron Pharmaceuticals, Inc. (NASDAQ: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)
在週二，再生元製藥公司（納斯達克：REGN）宣佈其在研究EYLEA HD（阿伐單抗）注射8毫克治療視網膜靜脈阻塞（RVO）患者的第三階段QUASAR試驗中達到了主要終點。
RVO is a blockage in one of the veins in the retina, the light-sensitive tissue at the back of the eye.
RVO是視網膜中一條靜脈的阻塞，視網膜是眼睛後部的光敏組織。
Also Read: Eye Drug Eylea Price Manipulation: Regeneron Faces US Justice Department Allegations Over Medicare Pricing Of Its Best-Selling Eye Drug
另請閱讀：眼藥Eylea價格操縱：再生元面臨美國司法部關於其暢銷眼藥藥物醫療保險定價的指控。
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.
在試驗中，每8周接受EYLEA HD治療的患者（在初始每月劑量後）與接受批准的每月給藥方案EYLEA（阿伐單抗）注射2毫克的患者相比，視力改善非劣於。
These data will be submitted to regulatory authorities around the world, with a submission to the FDA planned for the first quarter of 2025.
這些數據將提交給全球各地的監管機構，計劃在2025年第一季度向FDA提交。
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（n=591）的安全性特徵與QUASAR中的EYLEA（n=301）相似，並且與EYLEA HD在關鍵試驗中的已知安全性特徵總體一致。
EYLEA HD (known as Eylea 8 mg in the European Union and Japan) is being jointly developed by Regeneron and Bayer AG (OTC:BAYRY).
EYLEA HD（在歐盟和日本稱爲Eylea 8 mg）正在由再生元和拜耳(ADR)（場外交易：BAYRY）共同開發。
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.
在美國，再生元對EYLEA和EYLEA HD保持獨家權利。拜耳在美國以外獲得了獨家營銷權，其中兩家公司平分EYLEA和EYLEA HD銷售的利潤。
Last year, the FDA approved Eylea HD (aflibercept) Injection 8 mg for wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy (DR).
去年，FDA批准了Eylea HD（阿弗利巴肽）注射液8毫克用於溼性老年性黃斑變性、糖尿病性黃斑水腫和糖尿病視網膜病（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.
2024年第三季度Eylea HD和Eylea的美國淨銷售額相比2023年第三季度增長3%，達到了15.4億，包括來自Eylea HD的39200萬美元。
Price Action: REGN stock is up 2.04% at $739.64 at the last check on Tuesday.
價格走勢：截至週二最後一次檢查，REGN股票上漲2.04%，報$739.64。
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Image via Shutterstock
圖片來源：shutterstock
譯文內容由第三人軟體翻譯。
