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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 Frontiers in Ophthalmology published statistically significant results from a clinical study evaluating the efficacy and safety of a novel daily nutritional supplement formulated to address the symptoms of dry eyes.1 Bausch + Lomb expects to launch the supplement, which features a proprietary blend of ingredients including lutein, zeaxanthin isomers, curcumin and vitamin D3, under the brand name Blink™ NutriTears® early in the third quarter of 2024 in the U.S..
安大略省沃恩市——(商业新闻短讯)——致力于帮助人们更好地视力和更好地生活的全球领先眼科健康公司博士伦公司(纽约证交所/多伦多证券交易所:BLCO)今天宣布,《眼科前沿》发表了一项临床研究的统计结果,该研究评估了一种用于治疗干眼症的新型每日营养补充剂的功效和安全性。博士伦公司预计将于2024年第三季度初在美国推出该补充剂,该补充剂以Blink™Nutriters®品牌命名,由叶黄素、玉米黄质异构体、姜黄素和维生素D3等专有成分混合而成。。
The clinical study met both primary endpoints:
该临床研究符合两个主要终点:
Change from baseline at day 56 (week eight) in tear production (Schirmer’s test).
泪液产生(Schirmer试验)在第56天(第8周)从基线变化。
Change from baseline at day 56 in ocular symptoms measured by OSDI score.
通过OSDI评分测量的眼部症状从第56天的基线变化。
The study also met secondary endpoints, showing statistically significant improvements in tear-film break-up time (TBUT), osmolarity, ocular surface health and presence of an inflammatory marker.
该研究还达到了次要终点,显示泪膜破裂时间(TBUT),渗透压,眼表健康和炎症标志物存在的统计学显着改善。
“More than 150 million people experience dry eyes in the U.S.,” said Yehia Hashad, M.D., executive vice president, Research & Development and chief medical officer, Bausch + Lomb. “We believe Blink NutriTears will offer a novel nutritional option that can provide dry eye symptom relief in as little as two to four weeks.”.
博士伦博士伦研究与开发执行副总裁兼首席医疗官Yehia Hashad医学博士说:“美国有1.5亿多人患有干眼症。”。“我们相信Blink Nutriters将提供一种新颖的营养选择,可以在短短的两到四周内缓解干眼症。”。
Dry eyes are a prevalent ocular surface disorder that affects millions of adults worldwide. Once a condition known to traditionally affect adults over the age of 55, dry eye is impacting a younger demographic of consumers fueled by modern-day factors such as increased digital device use, environmental stressors, anxiety and stress.
干眼症是一种普遍存在的眼表疾病,影响着全世界数百万成年人。干眼症曾经是一种传统上影响55岁以上成年人的疾病,但由于数字设备使用量增加、环境压力、焦虑和压力等现代因素的推动,干眼症正在影响年轻的消费者群体。
Nearly 70% of consumers attribute their dry eye symptoms to digital device use..
近70%的消费者将其干眼症归因于数字设备的使用。。
The prospective, randomized, double-blind, parallel, placebo-controlled study evaluated the efficacy and safety of NutriTears in 155 adult participants with mild dry eye symptoms (aged 18–65; median age 42). Participants were randomized to receive one NutriTears or placebo capsule (NutriTears, n=77; placebo, n=78) per day for 56 days (eight weeks) and artificial tear use was captured..
这项前瞻性、随机、双盲、平行、安慰剂对照研究评估了Nutriters对155名患有轻度干眼症(年龄18-65岁;中位年龄42岁)的成年参与者的疗效和安全性。参与者被随机分配每天接受一个Nutriters或安慰剂胶囊(Nutriters,n=77;安慰剂,n=78),持续56天(八周),并捕获人工泪液的使用。。
Key points from the trial:
试验要点:
Primary endpoints
主要端点
The study met both of its primary endpoints: Change in tear production and participant reports of dry eye symptoms.
该研究符合其两个主要终点:泪液产生的变化和参与者报告的干眼症。
Participants consuming the daily NutriTears had significant improvements in tear production, as measured by change in Schirmer’s test scores from baseline compared to placebo to day 56 (week eight) (p<0.001 for both).
通过Schirmer测试分数从基线到安慰剂第56天(第八周)的变化来衡量,每天食用营养素的参与者在泪液产生方面有显着改善(两者均p<0.001)。
By day 14, total OSDI scores, as well as symptoms and vision domains of the OSDI significantly improved from baseline for participants consuming the daily NutriTears versus placebo, (p<0.05 for all) and were maintained to day 56 (p<0.001).
到第14天,与安慰剂组相比,每天食用营养素的参与者的OSDI总分以及OSDI的症状和视力领域从基线显着改善(均p<0.05),并维持到第56天(p<0.001)。
Key secondary endpoints
关键次要端点
Significant improvements in ocular surface staining, participant reported symptoms, and the inflammatory marker MMP-9 in participants consuming the daily NutriTears compared to placebo were seen at day 56.
在第56天,与安慰剂相比,服用每日营养素的参与者的眼表染色,参与者报告的症状和炎症标志物MMP-9显着改善。
By day 56, participants consuming the daily NutriTears had significantly improved TBUT and tear osmolarity, versus placebo (p<0.001).
到第56天,与安慰剂组相比,服用每日营养素的参与者的TBUT和泪液渗透压显着改善(p<0.001)。
Participants consuming the daily NutriTears supplement had significant improvements in corneal and conjunctival staining (p<0.001 for both), and inflammation, as assessed by presence of MMP-9, by day 56 (p<0.001 for each eye).
每天服用Nutriters补充剂的参与者在第56天的角膜和结膜染色(两者均p<0.001)和炎症(通过MMP-9的存在评估)方面有显着改善(每只眼睛p<0.001)。
Significant improvements in participant-reported ocular symptoms of dry eyes and participant experience of the frequency and severity of dry eye symptoms, as assessed by a SPEED questionnaire, were noted by day 14 for participants consuming the daily NutriTears versus placebo (p<0.05 for days 14 and 28) and maintained to day 56 (p<0.001)..
在第14天,参与者报告的干眼症的眼部症状和参与者对干眼症的频率和严重程度的体验有了显着改善,这是通过速度问卷评估的,与安慰剂相比,每天食用Nutriters的参与者在第14天和第28天有显着改善(p<0.05),并维持到第56天(p<0.001)。。
Participants were allowed to use artificial tears throughout the study; there was no difference between groups for artificial tear usage.
在整个研究过程中,参与者被允许使用人工泪液;人工泪液使用组之间没有差异。
NutriTears was found to be well-tolerated. No serious adverse events were reported during the study period.
发现Nutriters耐受性良好。研究期间未报告严重不良事件。
“These data suggest consumption of this new once-daily nutritional supplement may help restore tear film homeostasis by addressing the key root causes of dry eyes,” said Neda Gioia, OD, CNS, founder Integrative Vision, president, Ocular Wellness & Nutrition Society, and Blink NutriTears investigator.
“这些数据表明,通过解决干眼症的关键根本原因,食用这种新的每日一次的营养补充剂可能有助于恢复泪膜稳态,”Neda Gioia,OD,CNS,创始人Integrative Vision,眼部健康与营养协会主席,Blink Nutriters调查员说。
“This could represent a significant opportunity for consumers looking for options when it comes to long-lasting dry eye symptom relief.”.
“对于寻求长期缓解干眼症的消费者来说,这可能是一个重要的机会。”。
About the Blink Brand
关于Blink品牌
Blink is a leading brand of lubricating eye drops for dry eyes and dry contacts in the United States. The portfolio is formulated to relieve dryness and discomfort in the eyes. They work by moisturizing the surface of the eye and providing relief from irritation caused by factors such as prolonged screen time, environmental conditions or contact lens wear.
Blink是美国用于干眼和干接触的润滑滴眼液的领先品牌。该组合的配方可缓解眼睛的干燥和不适。它们的作用是滋润眼睛表面,缓解因长时间屏幕显示、环境条件或佩戴隐形眼镜等因素引起的刺激。
Bausch + Lomb plans to build upon the Blink product line later this year with Blink NutriTears clinically proven supplement for dry eyes..
博士伦计划今年晚些时候在Blink产品线的基础上,推出Blink Nutriters临床证明的干眼补充剂。。
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 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。其拥有约400种产品的综合产品组合,包括隐形眼镜、镜片护理产品、眼部护理产品、眼科药品、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。有关更多信息,请访问www.bausch.com,并通过X、LinkedIn、Facebook和Instagram与我们联系。。