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 the U.S. commercial launch of MIEBO (perfluorohexyloctane ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease (DED).

安大略省沃恩市-（商业线）-博士伦公司（NYSE/TSX:BLCO）是一家领先的全球眼保健公司，致力于帮助人们看到更好的生活，今天宣布美国商业推出MIEBO（全氟己基辛烷眼用溶液）用于治疗干眼病（DED）的体征和症状。

MIEBO is the first and only prescription eye drop approved for DED that directly targets tear evaporation..

MIEBO是第一个也是唯一一个批准用于DED的处方滴眼液，直接针对泪液蒸发。。

“More and more Americans are suffering from dry eye disease, due in large part to today’s multi-screen lifestyles,” said Andrew Stewart, president, Global Pharmaceuticals and International Consumer, Bausch + Lomb. “With MIEBO, eye care professionals now have a prescription eye drop that directly addresses tear evaporation, the leading cause of dry eye disease.”.

博士伦全球制药和国际消费者总裁安德鲁·斯图尔特（Andrew Stewart）说：“越来越多的美国人患有干眼症，这在很大程度上归功于当今的多屏生活方式。”。“使用MIEBO，眼保健专业人员现在可以使用处方滴眼液直接解决泪液蒸发问题，这是导致干眼病的主要原因。”。

DED affects more than 38 million Americans, with approximately nine in 10 experiencing evaporative dry eye.1,2 When not addressed, tear evaporation may lead to worsening of the condition by triggering a cycle of inflammation and ocular surface damage.3,4 MIEBO is a single ingredient, water-, preservative- and steroid-free prescription eye drop that spreads quickly and comfortably.

DED影响超过3800万美国人，大约十分之九的人患有蒸发性干眼症.1,2如果没有解决，泪液蒸发可能通过引发炎症和眼表损伤循环而导致病情恶化.3,4 MIEBO是一种单一成分，水，防腐剂和无类固醇的处方滴眼液，可快速舒适地传播。

It is designed to address the signs and symptoms of DED by reducing tear evaporation at the ocular surface.5-7.

它旨在通过减少眼表的泪液蒸发来解决DED的体征和症状。

The U.S. Food and Drug Administration (FDA) approved MIEBO in May 2023, based on consistent results from two pivotal phase 3 trials. Its clinical development program includes the first and only phase 3 program for any FDA-approved prescription DED product composed entirely of patients with both DED and clinical signs of Meibomian gland dysfunction (MGD).

根据两项关键的3期临床试验的一致结果，美国食品和药物管理局（FDA）于2023年5月批准了MIEBO。其临床开发计划包括任何FDA批准的处方DED产品的第一个也是唯一的第三阶段计划，该产品完全由患有DED和睑板腺功能障碍（MGD）临床症状的患者组成。

MGD is a major cause of DED development and progression, with approximately 86% of people with DED having excessive tear evaporation associated with MGD.2 In the clinical trials, MIEBO delivered significant improvements in the signs and symptoms of DED and consistently met its primary clinical sign and patient-reported symptom endpoint.

MGD是DED发展和进展的主要原因，大约86%的DED患者与MGD相关的泪液蒸发过多.2在临床试验中，MIEBO显着改善了DED的体征和症状，并始终符合其主要表现。临床症状和患者报告的症状终点。

The most common adverse reactions experienced with MIEBO was blurred vision (1% to 3% of patients reported blurred vision and eye redness)..

MIEBO最常见的不良反应是视力模糊（1%至3%的患者报告视力模糊和眼睛发红）。。

For more information on MIEBO, visit www.MIEBO.com.

有关MIEBO的更多信息，请访问www.MIEBO.com。

INDICATION

指示

MIEBO™ (perfluorohexyloctane ophthalmic solution) is used to treat the signs and symptoms of dry eye disease.

米博™ （全氟己基辛烷眼用溶液）用于治疗干眼病的体征和症状。

IMPORTANT SAFETY INFORMATION

重要的安全信息

Patients should remove contact lenses before using MIEBO and wait for at least 30 minutes before reinserting.

患者在使用MIEBO前应取下隐形眼镜，并在重新插入前等待至少30分钟。

It is important for patients to use MIEBO exactly as prescribed.

对于患者而言，完全按照规定使用MIEBO非常重要。

It is not known if MIEBO is safe and effective in children under the age of 18.

目前尚不清楚MIEBO对18岁以下儿童是否安全有效。

The most common eye side effect seen in studies was blurred vision (1% to 3 % of patients reported blurred vision and eye redness).

研究中最常见的眼部副作用是视力模糊（1%至3%的患者报告视力模糊和眼睛发红）。

Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

鼓励患者向FDA报告处方药的不良副作用。访问www.fda.gov/medwatch或致电1-800-fda-1088。

Click here for full Prescribing Information for MIEBO.

点击这里获取MIEBO的完整处方信息。

About Dry Eye Disease

关于干眼病

DED is a chronic inflammatory ocular surface disease that is commonly characterized by dryness, stinging, burning, grittiness and/or episodes of blurred vision.8,9 The two main types of dry eye disease are aqueous deficient and evaporative. Aqueous-deficient dry eye occurs when the eyes do not produce enough tears.

DED是一种慢性炎症性眼表疾病，通常以干燥，刺痛，灼热，砂砾和/或视力模糊为特征.8,9干眼病的两种主要类型是缺水和蒸发。当眼睛没有产生足够的眼泪时，就会出现缺水的干眼症。

Evaporative dry eye is due to a deficient tear film lipid layer. The most common type of dry eye is evaporative.2.

蒸发性干眼症是由于泪膜脂质层不足。最常见的干眼类型是蒸发。

About MIEBO Phase 3 Clinical Trials

关于MIEBO 3期临床试验

FDA approval of MIEBO was based on results from two 57-day, multi-center, randomized, double-masked saline-controlled studies, GOBI and MOJAVE. The studies assessed a total of 1,217 patients who received MIEBO or hypotonic saline (0.6%) in a 1:1 ratio.10,11

FDA批准MIEBO是基于两项为期57天，多中心，随机，双盲盐水对照研究GOBI和MOJAVE的结果。这些研究评估了总共1217名以1:1的比例接受MIEBO或低渗盐水（0.6%）的患者.10,11

In these studies, MIEBO met both primary sign and symptom efficacy endpoints. The two primary endpoints were change from baseline at week eight (day 57 ± 2) in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) score. Patients experienced relief of symptoms as early as day 15 and through day 57 with statistically significant reduction in VAS eye dryness score favoring MIEBO observed in both studies.

在这些研究中，MIEBO符合主要症状和症状疗效终点。两个主要终点是总角膜荧光素染色（tCFS）和眼干燥视觉模拟评分（VAS）评分在第8周（第57±2天）从基线变化。早在第15天和第57天，患者症状缓解，VAS眼干燥评分在统计学上显着降低，有利于两项研究中观察到的MIEBO。

Additionally, at days 15 and day 57, a significant reduction in tCFS favoring MIEBO was observed in both studies..

此外，在第15天和第57天，在两项研究中观察到有利于MIEBO的TCF显着降低。。

The most common adverse reactions experienced with MIEBO was blurred vision (1% to 3% of patients reported blurred vision and eye redness).

MIEBO最常见的不良反应是视力模糊（1%至3%的患者报告视力模糊和眼睛发红）。

About Bausch + Lomb

关于Bausch

Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. Its comprehensive portfolio of more than 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礼物-从出生到生命的每个阶段。其全面的400多种产品组合包括隐形眼镜，镜片护理产品，眼保健产品，眼科药物，非处方产品以及眼科手术器械和器械。

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 Twitter, LinkedIn, Facebook and Instagram..

博士伦成立于1853年，拥有重要的全球研发，制造和商业足迹，约有13000名员工，并在近100个国家/地区设有。博士伦总部设在安大略省沃恩市，公司总部设在新泽西州布里奇沃特。欲了解更多信息，请访问www.bausch.com并在Twitter，LinkedIn，Facebook和Instagram上与我们联系。。

Forward-looking Statements

前瞻性声明

This news release may contain forward-looking statements, which may generally be identified by the use of the words “anticipates,” “hopes,” “expects,” “intends,” “plans,” “should,” “could,” “would,” “may,” “believes,” “estimates,” “potential,” “target,” or “continue” and variations or similar expressions.

该新闻稿可能包含前瞻性陈述，通常可以通过使用“预期”，“希望”，“期望”，“意图”，“计划”，“应该”，“可以”，“将会”，“可以”相信，“估计”，“潜力”，“目标”或“继续”以及变体或类似表达。

These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in Bausch + Lomb’s filings with the U.S.

这些声明基于当前对管理层的期望和信念，并且存在某些风险和不确定性，可能导致实际结果与前瞻性声明中描述的结果大不相同。这些风险和不确定性包括但不限于博士伦与美国的文件中讨论的风险和不确定性。

Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch + Lomb undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law..

证券交易委员会和加拿大证券管理员，这些因素通过引用并入本文。提醒读者不要过分依赖这些前瞻性陈述。这些前瞻性声明仅在本协议签署之日起生效。除非法律要求，否则博士伦不承担更新任何这些前瞻性陈述的义务，以反映本新闻发布之日以后的事件或情况或反映实际结果。。

References

工具书类

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Downs P.2020干眼产品市场报告：2019年至2025年的全球分析。市场范围；2020.

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Lemp，MA，Crews，LA，Bron AJ。(2012). 临床队列中水缺乏和蒸发性干眼症的分布：一项回顾性研究。Cornea，31（5），472-478。2012;31（5）：472-478。doi:10.109/ICO.0b013e318225415a。

Craig JP, Nelson JD, Azar DT, et al. TFOS dews II report executive summary. Ocul Surf. 2017;15(4):802-812. doi:10.1016/j.tos.2017.08.003.

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Baudouin C, Messmer EM, Aragona P, et al. Revisiting the vicious circle of dry eye disease: a focus on the pathophysiology of meibomian gland dysfunction. Br J Ophthalmol. 2016;300-203. doi:10.1136/bjophthalmol-2015-307415.

Baudouin C，Messmer EM，Aragona P，et al。重温干眼病的恶性循环：关注睑板腺功能障碍的病理生理学。Br J Ophthalmol。2016;300-203.doi:10.1136/bjophthalmol-2015-307415。

Data on file.

数据在文件中。

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Nichols KK，Foulks GN，Bron AJ，et al。睑板腺功能障碍国际研讨会：执行摘要。投资Ophthalmol Vis Sci。2011;52（4）：1922-1929。doi:10.1167/iovs.10-6997a

Borchman D, Vittitow J, Ewurum A, Veligandl SR. Spectroscopic study of perfluorohexyloctane human Meibum interactions. Invest Ophthalmol Vis Sci. 2022;63:1525.

Borchman D，Vittitow J，Ewurum A，Veligandl SR。全氟己酸-人睑蛋白相互作用的光谱研究。投资Ophthalmol Vis Sci。2022;63:1525.

Dana R, Bradley JL, et al. Estimated prevalence and incidence of dry eye disease on coding analysis of a large, all-age United States health care system. Am J Ophthalmol. 2019;202:47-54. doi:10.1016/j.ajo.2019.01.026.

Dana R，Bradley JL等人。在大型全年龄美国医疗保健系统的编码分析中估计干眼病的患病率和发病率。Am J Ophthalmol。2019;202:47-54。doi:10.1016/j.ajo.2019.01.026。

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Tauber J, Berdy GJ, Wirta DL, et al. NOV03 for dry eye disease associated with meibomian gland dysfunction: Results of the Randomized Phase 3 GOBI Study. Ophthalmology. 2023;130(5):516-524. doi:10.1016/j.ophtha.2022.12.021.

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© 2023 Bausch Lomb。

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