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博士伦enVista® Envy™全视力人工晶状体获得FDA批准

Bausch + Lomb Receives FDA Approval for enVista ® Envy™ Full Range of Vision Intraocular Lens

businesswire 等信源发布 2024-10-15 14:27

可切换为仅中文


VAUGHAN, Ontario--(BUSINESS WIRE)--Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced that the U.S. Food and Drug Administration has approved the enVista® Envy™ full range of vision intraocular lens (IOL), which offers a continuous range of vision with excellent dysphotopsia tolerance on the widely used enVista IOL platform..

安大略省沃恩市——(商业新闻短讯)——Bausch+Lomb Corporation(纽约证交所/多伦多证交所:BLCO)是一家致力于帮助人们更好地视力以更好地生活的全球领先眼科健康公司,今天宣布,美国食品和药物管理局已批准enVista®Envy™全视野人工晶状体(IOL),该人工晶状体在广泛使用的enVista IOL平台上提供连续的视力范围,并具有出色的视困难耐受性。

“We’re confident that U.S. surgeons will agree with what their Canadian colleagues have already told us: enVista Envy delivers exceptional outcomes and meets cataract patients’ high expectations, as well as their own,” said Anthony Wallace, vice president and general manager, U.S. Surgical, Bausch + Lomb..

博士伦美国外科副总裁兼总经理安东尼·华莱士(AnthonyWallace)表示:“我们相信,美国外科医生会同意他们的加拿大同事已经告诉我们的话:EnvistaEnvy可以带来非凡的结果,满足白内障患者以及他们自己的高期望。”

A multicenter, randomized and controlled clinical trial evaluating 332 subjects demonstrated excellent long-term outcomes with the enVista Envy IOL in the U.S.1 On average, 86% of patients reported little to no bothersomeness for dysphotopsia (glare, halo, starbursts), showing an impressive tolerance profile overall.1 In a Canadian clinical study evaluating 110 subjects, 94% of patients reported little to no difficulty viewing close objects, and 93% were completely to moderately satisfied with their vision post-surgery.2.

一项多中心,随机和对照的临床试验评估了332名受试者,在美国使用enVista Envy IOL显示出良好的长期疗效[1]。平均而言,86%的患者报告对视力不良(眩光,光晕,星光爆发)几乎没有或没有烦扰,总体上表现出令人印象深刻的耐受性[1]。在一项评估110名受试者的加拿大临床研究中,94%的患者报告几乎没有看到近距离物体的困难,93%的患者对手术后的视力完全满意。

Envy delivers outstanding performance in all lighting conditions thanks to ActivSync Optic intelligent energy distribution, which optimizes vision in many lighting conditions. Envy also enables surgeons to treat a wider range of astigmatic patients with more accuracy and precision with 0.5D steps (or less) throughout the cylinder range..

凭借ActivSync Optic intelligent energy distribution,Envy在所有照明条件下都具有出色的性能,可在许多照明条件下优化视觉。嫉妒还使外科医生能够在整个圆柱体范围内以0.5D(或更少)的步长更准确和精确地治疗更广泛的散光患者。

“I’ve long trusted the enVista platform to deliver excellent outcomes for my cataract patients,” said Alice Epitropoulos, MD, Ophthalmic Surgeons & Consultants of Ohio and principal investigator in the Phase 3 U.S. clinical trial. “I expect that having a lens on the same platform that offers a full range of vision with minimal visual disturbances, as well as a toric option for precision astigmatism correction, will significantly enhance my ability to achieve that goal.”.

“我希望在同一平台上拥有一个可以提供全方位视觉且视觉干扰最小的镜头,以及一个用于精确散光矫正的复曲面选项,将大大提高我实现这一目标的能力。”

enVista Envy IOLs will be commercially available in the U.S. on a limited basis in the coming weeks and more broadly in 2025. Bausch + Lomb is also in the process of seeking regulatory approvals for the lens in additional markets.

enVista Envy人工晶体将在未来几周内在美国有限范围内上市,2025年将在更广泛的范围内上市。博士伦也在寻求其他市场对该镜头的监管批准。

About Bausch + Lomb

关于博士伦

Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments.

博士伦致力于保护和增强世界各地数百万人的视力,从出生到生命的每个阶段。其大约400种产品的综合组合包括隐形眼镜、镜片护理产品、眼部护理产品、眼科药物、非处方产品以及眼科手术设备和仪器。

Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,000 employees and a presence in nearly 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario, with corporate offices in Bridgewater, New Jersey. For more information, visit www.bausch.com and connect with us on X, LinkedIn, Facebook and Instagram..

博士伦公司成立于1853年,在全球拥有重要的研发、制造和商业足迹,拥有约13000名员工,业务遍及近100个国家。博士伦总部位于安大略省沃恩,公司办事处位于新泽西州布里奇沃特。