Presentation at the American Academy of Optometry (AAOPT) 2023 showed significant improvements with CEQUA® for topical ophthalmic use in both corneal fluorescein staining (CFS) and symptom questionnaire scores starting at 4 weeks and continuing to 12 weeks

美国视光学会（AAOPT）2023的报告显示，CEQUA®在角膜荧光素染色（CFS）和症状问卷评分方面的局部眼科使用显着改善，从4周开始并持续至12周

Study design mirrors real-world experience with dry eye disease, including allowing use of artificial tears and measurement of CFS in all five corneal zones

研究设计反映了干眼病的实际经验，包括允许使用人工泪液和测量所有五个角膜区域的CF

MUMBAI, India and PRINCETON, N.J., Oct. 12, 2023 /PRNewswire/ -- Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, 'Sun Pharma' and includes its subsidiaries and/or associate companies) today announced the presentation of Phase 4 data showing that CEQUA® (cyclosporine ophthalmic solution) 0.09% induces sustained improvement in the signs and symptoms of dry eye disease (DED).

孟买，印度和普林斯顿，新泽西州，10月12日，2023/PRNewswire/--Sun Pharmaceutical Industries Limited（路透社：Sun.BO，彭博：SUNP-IN，NSE:SUNPHARMA，疯牛病：524715，“Sun Pharma”，包括其子公司和/或关联公司）今天宣布提交阶段4数据显示CEQUA®（环孢菌素眼用溶液）0.09%诱导干眼病（DED）体征和症状的持续改善。

CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). In a presentation at the American Academy of Optometry (AAOPT) 2023 annual meeting in New Orleans, La., researchers reported that CEQUA elicited significant improvement in corneal fluorescein staining (CFS, a test used to detect damage to the cornea) and in modified Symptom Assessment in Dry Eye (mSANDE) scores in patients with DED whose disease was uncontrolled on Restasis® (cyclosporine ophthalmic emulsion) 0.05% therapy.1.

CEQUA眼用溶液是一种钙调神经磷酸酶抑制剂免疫抑制剂，用于增加干燥性角膜结膜炎（干眼症）患者的泪液产生。在美国视光学会（AAOPT）2023年会上在洛杉矶新奥尔良举行的演讲中。，研究人员报告说，CEQUA引起角膜荧光素染色（CFS，一种用于检测角膜损伤的测试）和DED患者干眼症状评估（mSANDE）评分的显着改善，这些患者的疾病在Restasis®上无法控制（环孢菌素）眼用乳液）0.05%治疗。

In the 12-week Phase 4 multicenter study, twice-daily administration of CEQUA improved CFS and mSANDE scores starting at Week 4 of treatment and maintained these improvements through Week 12. CEQUA offers a high concentration of cyclosporine for ophthalmic use and is the first and only U.S. Food and Drug Administration (FDA)-approved cyclosporine treatment delivered with nanomicellar NCELL® technology, which helps to improve the bioavailability of cyclosporine, resulting in improved ocular tissue penetration..

在为期12周的4期多中心研究中，CEQUA每日两次给药从治疗第4周开始改善CFS和mSANDE评分，并在第12周保持这些改善。CEQUA为眼科使用提供高浓度的环孢菌素，是美国食品和药物管理局（FDA）首次且唯一批准的使用纳米胶束NCELL®技术进行环孢菌素治疗，有助于提高环孢菌素的生物利用度，从而改善眼组织渗透性。。

'We were greatly encouraged to observe significant improvements in dry eye signs and symptoms as early as four weeks into treatment with CEQUA, and to see even greater improvements at eight weeks and again at 12 weeks,' said lead investigator Josh Johnston, OD, FAAO, of Georgia Eye Partners in Atlanta, Ga.

首席研究员Josh Johnston，OD，首席研究员Josh Johnston说：“我们非常鼓励在CEQUA治疗四周后观察到干眼症状和体征的显着改善，并在8周和12周时观察到更大的改善。FAAO，佐治亚州亚特兰大佐治亚州眼科合作伙伴。

'Moreover, by assessing corneal fluorescein staining in all five zones of the cornea, we were able to attain a more complete characterization of corneal health than in many dry eye disease trials, which typically assess only a few corneal areas.'.

“此外，通过评估角膜所有五个区域的角膜荧光素染色，我们能够获得比许多干眼病试验更完整的角膜健康特征，这些试验通常仅评估少数角膜区域。”。

The study enrolled adults with DED inadequately controlled (i.e., still symptomatic and/or exhibiting disease signs) on current Restasis® therapy for at least three months, and who had a history and clinical diagnosis of DED for at least three months before screening/baseline. Patients received one drop of CEQUA in each eye twice daily for 12 weeks.

该研究招募了目前Restasis®治疗中DED控制不足（即仍有症状和/或表现出疾病迹象）的成人至少3个月，并且在筛查/基线前至少有3个月的DED病史和临床诊断。患者每只眼睛每天两次接受一滴CEQUA，持续12周。

Investigators assessed CFS and mSANDE scores at baseline and at Weeks 4, 8, and 12, and/or upon early discontinuation from the study. CFS was scored on a 0-4 grading scale in 0.5-point increments, with a score of 0 indicating no stain (i.e., healthy cornea) and a score of 4 reflecting a severe stain; investigators calculated a total CFS score by summing all five corneal area scores.

研究人员在基线和第4,8和12周以及/或早期停止研究时评估CFS和mSANDE评分。CFS以0.5分为增量以0-4分制评分，0分表示无染色（即健康角膜），4分反映严重染色；研究人员通过总结所有五个角膜面积分数来计算总CFS分数。

The mSANDE questionnaire assessed frequency and severity of DED symptoms of dryness and irritation on a 0-100 scale, with 0 representing very low frequency/severity and 100 indicating very high frequency/severity..

mSANDE问卷以0-100的等级评估干燥和刺激的DED症状的频率和严重程度，其中0表示非常低的频率/严重性，100表示非常高的频率/严重性。。

Dr. Johnston and colleagues presented results from 124 patients in the modified intent-to-treat (mITT) population. The mean (standard deviation [SD]) age of the patients was 65.5 (11.6) years; 110 of the patients (88%) were female. The mean (SD) total CFS score was 5.7 (3.37) at baseline, and improved significantly (P <0.0001) to 4.0 (3.12) at Week 4, 2.9 (2.54) at Week 8, and 2.7 (2.36) at Week 12.

Johnston博士及其同事介绍了124例改良意向治疗（mITT）人群的结果。患者的平均年龄（标准差[SD]）为65.5（11.6）岁；110名患者（88%）是女性。基线时平均（SD）总CFS评分为5.7（3.37），第4周显着改善（P<0.0001）至4.0（3.12），第8周为2.9（2.54），第12周为2.7（2.36）。

Similarly, the mean (SD) mSANDE score was 67.1 (21.05) at baseline and improved significantly (P <0.0001) to 48.4 (23.31) at Week 4, 44.2 (24.28) at Week 8, and 38.3 (25.99) at Week 12..

同样，基线时的平均（SD）mSANDE得分为67.1（21.05），并在第4周显着改善（P<0.0001）至48.4（23.31），在第8周显着改善44.2（24.28），在第12周显着改善38.3（25.99）。。

CEQUA was generally well tolerated in the study, consistent with its established safety profile, and there were no new safety signals in the trial. Overall, 58 patients (43.3%) reported at least one treatment-emergent adverse event (AE); most AEs were mild in severity (73.8%). The most common treatment-related AEs were instillation site irritation and instillation site pain; all other treatment-related AEs occurred in fewer than 2% of patients..

CEQUA在研究中一般耐受性良好，符合其既定的安全性，并且在试验中没有新的安全性信号。总体而言，58名患者（43.3%）报告至少一种治疗紧急不良事件（AE）；大多数AE的严重程度较轻（73.8%）。最常见的治疗相关AE是滴注部位刺激和滴注部位疼痛；所有其他与治疗相关的AE发生率不到2%。。

'In addition to the rapid and sustained symptomatic improvement in patients with dry eye disease treated with CEQUA, this study is notable for its design, which allows for use of artificial tears, thus replicating real-world conditions as closely as possible for a controlled clinical trial,' noted Brittany Mitchell, OD, Head of Medical Affairs, Ophthalmics, at Sun Pharma.

“除了用CEQUA治疗的干眼病患者的快速和持续的症状改善之外，这项研究的设计还值得注意，它允许使用人工泪液，从而尽可能地复制现实世界的条件以进行对照临床试验，“Sun Pharma医疗事务，眼科负责人Brittany Mitchell指出。

'The data presented at the American Academy of Optometry meeting represent the first of a series of assessments from this trial, with results thus far consistent with the efficacy, safety, and convenient dosing of CEQUA. We look forward to sharing additional information as we continue to analyze the data from this trial.'.

'美国视光学会会议上提供的数据代表了该试验的一系列评估中的第一项，迄今为止的结果与CEQUA的有效性，安全性和方便的剂量一致。我们期待在继续分析本次试验的数据时分享更多信息。

About CEQUA®

关于CEQUA®

CEQUA® (cyclosporine ophthalmic solution) 0.09% is a patented, novel, proprietary nanomicellar NCELL formulation of cyclosporine in a clear, preservative-free, aqueous solution. It is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye), an inflammatory disease that afflicts more than 16 million people in the U.S.2 CEQUA is the first and only U.S.

CEQUA®（环孢素眼用溶液）0.09%是一种专利的，新颖的，专有的环孢素纳米胶束NCELL配方，在透明，无防腐剂的水溶液中。据指出，增加干燥性角膜结膜炎（干眼症）患者的泪液产生，这是一种在美国折磨超过1600万人的炎症性疾病.2 CEQUA是第一个也是唯一的美国。

Food and Drug Administration (FDA)-approved cyclosporine treatment delivered with nanomicellar NCELL technology, which helps to improve the bioavailability and physicochemical stability of cyclosporine, resulting in improved ocular tissue penetration..

美国食品和药物管理局（FDA）批准使用纳米胶束NCELL技术进行环孢菌素治疗，这有助于提高环孢菌素的生物利用度和物理化学稳定性，从而改善眼组织渗透性。。

CEQUA is dosed twice daily and is available as a single-use vial. In a multicentered, randomized, double-masked, vehicle-controlled Phase 3 confirmatory study involving 744 patients with dry eye, investigators observed clinically and statistically significant improvements in tear production and ocular surface integrity in patients treated with CEQUA, compared to vehicle.

CEQUA每天给药两次，可作为一次性小瓶使用。在一项涉及744名干眼症患者的多中心，随机，双盲，载体控制的3期确证研究中，研究人员观察到与载体相比，用CEQUA治疗的患者的泪液产生和眼表完整性在临床和统计学上显着改善。

CEQUA treatment was well tolerated in the Phase 3 trial; treatment-emergent adverse events were primarily mild in intensity. In a prior Phase 2b/3 clinical trial with 455 patients, CEQUA demonstrated clinically and statistically significant increases in tear production (16.8% of patients with an increase of ≥10 mm in Schirmer's score from baseline after 84 days of treatment, versus 8.6% for vehicle; p<0.01) and was well tolerated by the study population.

CEQUA治疗在3期试验中耐受性良好；治疗紧急不良事件的强度主要是轻微的。在先前的455例患者的2b/3期临床试验中，CEQUA显示泪液产生的临床和统计学显着增加（治疗84天后Schirmer评分从基线增加≥10mm的患者为16.8%，而8.6%为车辆；p<0.01）并且被研究人群良好耐受。

Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle. From both clinical trials, the most common adverse reaction following the use of cyclosporine ophthalmic solution 0.09% was instillation site pain (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of the patients were eye irritation, blepharitis, urinary tract infection, headache, and bronchitis..

此外，与车辆相比，几个关键的次要终点显示出统计学上显着的改善。从两项临床试验中，使用环孢菌素眼用溶液0.09%后最常见的不良反应是滴注部位疼痛（22%）和结膜充血（6%）。在1%至5%的患者中报告的其他不良反应是眼睛刺激，睑缘炎，尿路感染，头痛和支气管炎。。

INDICATIONS AND USAGECEQUA® (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).

适应症和用途CEQUA®（环孢菌素眼用溶液）0.09%是一种钙调神经磷酸酶抑制剂免疫抑制剂，用于增加干燥性角膜结膜炎（干眼症）患者的泪液产生。

IMPORTANT SAFETY INFORMATION

重要的安全信息

WARNINGS AND PRECAUTIONS

警告和注意事项

Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.

眼睛受伤和污染的可能性：为避免眼睛受伤和污染的可能性，建议患者不要将小瓶尖端接触到眼睛或其他表面。

Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.

与隐形眼镜一起使用：佩戴隐形眼镜时不应使用CEQUA。如果佩戴隐形眼镜，应在服用溶液前将其取下。施用CEQUA眼用溶液15分钟后可重新插入镜片。

ADVERSE REACTIONSThe most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.

不良反应超过5%的患者报告的最常见不良反应是滴注滴剂（22%）和结膜充血（6%）时疼痛。1%至5%的患者报告的其他不良反应是睑缘炎，眼睛刺激，头痛和尿路感染。

Please click for Full Prescribing Information & for more information visit CEQUAPRO.com

请点击以获取完整的处方信息和更多信息，请访问CEQUAPRO.com

About Dry Eye Disease

关于干眼病

Dry eye is a burdensome, chronic disease affecting millions of patients around the world, with a significant population, greater than 16 million patients, present in the United States.2

干眼症是一种繁重的慢性疾病，影响着全世界数百万患者，在美国有大量人口，超过1600万患者

Dry eye disease, as defined by the National Eye Institute (NEI, a division of the U.S. National Institutes of Health), occurs when the quantity and/or quality of tears fails to keep the surface of the eye properly lubricated. The disease causes a scratchy sensation or a feeling that something is in the eye.

根据国家眼科研究所（NEI，美国国立卫生研究院的一个部门）的定义，当眼泪的数量和/或质量不能保持眼睛表面正确润滑时，就会发生干眼病。该疾病会引起搔痒感或感觉到眼睛里有东西。

Other symptoms include stinging or burning, episodes of excess tearing following periods of stress, discharge, pain, and redness in the eye. The risk of developing dry eye increases with advancing age and is more common in women than in men..

其他症状包括刺痛或灼热，压力，分泌物，疼痛和眼睛发红后出现过度撕裂。随着年龄的增长，患干眼症的风险增加，女性比男性更常见。。

Disclaimer:

免责声明：

Statements in this 'Document' describing the Company's objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be 'forward looking statements' within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied..

本“文件”中描述公司目标，预测，估计，期望，计划或预测或行业条件或事件的陈述可能是适用证券法律法规范围内的“前瞻性陈述”。实际结果，表现或成就可能与表达或暗示的结果大不相同。。

About Sun Ophthalmics

关于太阳眼科学

Backed by Sun Pharma's global expertise in R&D, Sun Ophthalmics (the branded ophthalmic division of Sun Pharma's wholly owned subsidiary) is leading the way through the development of innovative products and in partnership with eye care professionals. In addition to CEQUA® (cyclosporine ophthalmic solution) 0.09%, Sun Ophthalmics markets BromSite® (bromfenac ophthalmic solution) 0.075% and XELPROS® (latanoprost ophthalmic solution) 0.005% in the U.S.

在Sun Pharma在研发方面的全球专业知识的支持下，Sun Ophthalmics（Sun Pharma合资子公司的品牌眼科）正在通过创新产品的开发和与眼保健专业人员的合作开辟道路。除了0.09%的CEQUA®（环孢菌素眼用溶液）外，Sun Ophthalmics在美国销售0.075%的BromSite®（bromfenac眼用溶液）和0.005%的XELPROS®（拉坦前列素眼用溶液）。

Sun Ophthalmics' dedicated team is focused solely on the needs of eye care professionals, offering timely, knowledgeable support at every turn. The company strives to deliver products built on unique platforms that integrate seamlessly into the eye care practice, helping eye care professionals to continue providing quality medicine.

太阳眼科专业团队专注于眼保健专业人员的需求，每一轮都提供及时，知识渊博的支持。该公司致力于提供基于独特平台的产品，这些平台无缝集成到眼保健实践中，帮助眼保健专业人员继续提供优质药物。

Discover a brighter future in eye care at www.sunophthalmics.com..

在www.sunophthalmics.com上发现眼科护理的光明未来。。

About Sun Pharmaceutical Industries Limited (CIN - L24230GJ1993PLC019050)

关于太阳制药有限公司（CIN-L24230GJ1993PLC019050）

Sun Pharma is the world's fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. It is the largest pharmaceutical company in India, and is a leading generic company in the US as well as Global Emerging Markets. Sun's high growth Global Specialty portfolio spans innovative products in dermatology, ophthalmology, and onco-dermatology and accounts for over 16% of company sales.

Sun Pharma是全球第四大专业仿制药公司，在专业，仿制药和消费者医疗保健产品方面都有业务。它是印度最大的制药公司，是美国领先的仿制药公司以及全球新兴市场。Sun的高增长全球专业组合涵盖皮肤科，眼科和onco皮肤科的创新产品，占公司销售额的16%以上。

The company's vertically integrated operations deliver high-quality medicines, trusted by physicians and consumers in over 100 countries. Its manufacturing facilities are spread across six continents. Sun Pharma is proud of its multi-cultural workforce drawn from over 50 nations. For further information, please visit www.sunpharma.com and follow us on Twitter @SunPharma_Live.

该公司的纵向一体化运营提供高质量的药品，受到100多个国家医生和消费者的信任。其制造设施遍布六大洲。Sun Pharma为来自50多个国家的多文化劳动力感到自豪。有关详细信息，请访问www.sunpharma.com并在Twitter@sunpharma_Live上关注我们。

References:

参考文献：

Johnston, J. Effect of OTX-101 0.09% on corneal staining and SANDE scores in patients with dry eye disease uncontrolled on cyclosporine ophthalmic emulsion 0.05%. Abstract presented at American Academy of Optometry 2023; October 12, 2023; New Orleans, LA.

约翰斯顿，J。OTX-101 0.09%对环孢菌素眼用乳剂未控制的干眼病患者角膜染色和SANDE评分的影响0.05%。摘要见美国视光学会2023；2023年10月12日；新奥尔良，洛杉矶。

New study focuses on scope of dry eye disease in the U.S. American Optometric Association; 2017. Available at: https://www.aoa.org/news/clinical-eye-care/new-study-dry-eye-disease. Accessed September 10, 2019

新研究侧重于美国验光协会干眼病的范围；2017.可在：https://www.aoa.org/news/clinical-eye-care/new-study-dry-eye-disease.2019年9月10日访问

© 2023 Sun Pharmaceutical Industries, Inc. All trademarks are the property of their respective owners.

©2023 Sun Pharmaceutical Industries，Inc。所有商标均为其各自所有者的财产。

SOURCE Sun Pharma

来源Sun Pharma