林业发展局批准Yuvezzi, 首次使用固定剂量的眼滴,用于预视波比亚,提供非侵入性视力改善。
FDA approves Yuvezzi, first fixed-dose eye drop for presbyopia, offering non-invasive vision improvement.
林业发展局批准了Yuvezzi,这是每天将carbachol和brimonidine薄凝酸盐合在一起的眼滴,作为首次固定剂量治疗前天草原的治疗,这是一种常见的与年龄有关的近视损失,影响到数百万人。
The FDA has approved Yuvezzi, a daily eye drop combining carbachol and brimonidine tartrate, as the first fixed-dose treatment for presbyopia, a common age-related near-vision loss affecting millions.
药物的作用是,通过学生收缩造成针孔效应,使近距离和远距离视力得到改善,时间最长达8小时。
The medication works by creating a pinhole effect through pupil constriction, improving both near and distance vision for up to 8 hours.
核准的依据是两个阶段3的试验,显示近视率有了显著改善,在72 000个治疗日中没有严重的安全问题。
Approval was based on two Phase 3 trials showing significant near vision improvement with no serious safety issues over 72,000 treatment days.
常见副作用包括头痛、眼刺激和暂时模糊视力。
Common side effects include headache, eye irritation, and temporary blurred vision.
该药预计将于2026年第二季度推出,为眼镜或外科手术提供了非侵入性的替代药。
The drug, expected to launch in the second quarter of 2026, offers a non-invasive alternative to glasses or surgery.