Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (the RAINIER Study)

The objective of this study is to evaluate the safety and effectiveness of OC-02 nasal spray compared to placebo on signs and symptoms of dry eye disease (DED).

开始日期2018-08-14

申办/合作机构

Oyster Point Pharma, Inc.

NCT03452397 / Completed临床2期

Multicenter, Randomized, Controlled, Double-Masked Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease (The PEARL Study)

The objective of this study is to evaluate the safety and effectiveness of OC-02 Nasal Spray as compared to placebo on signs and symptoms of dry eye disease.

开始日期2018-02-27

申办/合作机构

Oyster Point Pharma, Inc.

100 项与 OC-02 相关的临床结果

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100 项与 OC-02 相关的转化医学

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100 项与 OC-02 相关的专利（医药）

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项与 OC-02 相关的文献（医药）

2022-09-01·Clinical therapeutics

Efficacy and Safety of Single-dose OC-02 (Simpinicline Solution) Nasal Spray on Signs and Symptoms of Dry Eye Disease: The PEARL Phase II Randomized Trial

Article

作者: Pattar, Guruprasad R ; Jerkins, Gary ; Torkildsen, Gail L ; Nau, Jeffrey ; Striffler, Kristen

PURPOSE:

Dry eye disease is a multifactorial disorder that affects the ocular surface, with symptoms including ocular irritation, impaired vision, and pain. Nicotinic acetylcholine receptor (nAChR) agonists are novel treatments for dry eye disease; this study investigates the nAChR agonist OC-02 (simpinicline solution) as an aqueous nasal spray.

METHODS:

PEARL (Clinical Trial to Evaluate the Efficacy of OC-02 Nasal Spray on Signs and Symptoms of Dry Eye Disease) was a Phase II study that evaluated the efficacy and safety of OC-02 (simpinicline solution) nasal spray (OC-02 SNS) in adult patients with dry eye disease. Patients ≥22 years of age were eligible if they had an Ocular Surface Disease Index score ≥23, corneal fluorescein staining score ≥2 in >1 region or ≥4 for all regions, or Schirmer test score (STS) ≤10 mm; there were no restrictions on eye dryness score (EDS). Patients (N = 165) were randomly assigned 1:1:1:1 to vehicle (control; n = 42) or OC-02 SNS (0.11 mg, 0.55 mg, or 1.1 mg; n = 41 per group) and received a single dose of study drug (100 µL using a nasal spray atomizer) at visit 1 and visit 2 (15-19 days after visit 1). Primary efficacy outcomes were change in the STS from baseline to immediately after treatment administration (visit 1) and change in the EDS from before to 5 minutes after treatment during controlled adverse environment exposure (visit 2).

FINDINGS:

Baseline demographic and ocular clinical characteristics were similar across all groups. Single-dose OC-02 SNS improved the signs and symptoms of dry eye disease. For the STS, statistically significant and dose-dependent improvements were found from before to after treatment with OC-02 SNS versus vehicle (least-squares mean change from baseline: vehicle, 3.0 mm; 0.11 mg OC-02 SNS, 9.0 mm; 0.55 mg, 17.5 mm; and 1.1 mg, 19.6 mm). For EDS, statistically significant and dose-dependent improvements were found from before to 5 minutes after treatment with higher doses of OC-02 SNS versus vehicle (least-squares mean change from baseline: vehicle, -6.5; 0.11 mg OC-02 SNS, -9.4; 0.55 mg, -17.4; and 1.1 mg, -20.7). OC-02 SNS was well tolerated: only 2 ocular adverse events were reported (eye pruritis and keratitis), and the most common nonocular events were cough and throat irritation.

IMPLICATIONS:

Single-dose OC-02 SNS over a range of doses immediately and significantly increased tear production and improved eye dryness. Together with previous studies of OC-01 (varenicline solution) nasal spray, our findings suggest that agonist stimulation of nAChRs in the nasal cavity is a valid and effective mechanism to elicit natural tear production in patients with dry eye disease.

CLINICALTRIALS:

gov identifier: NCT03452397.

2016-04-01·Thrombosis research3区 · 医学

OC-02 - Risk of arterial thromboembolism in patients with breast cancer

3区 · 医学

Article

作者: A.S. Reiner ; M.S.V. Elkind ; L.M. DeAngelis ; K.S. Panageas ; B.B. Navi ; C. Iadecola ; H. Kamel

INTRODUCTION:

Breast cancer is the most common cancer in women and clearly increases the risk of venous thromboembolism. However, its association with arterial thromboembolism is less well defined.

AIM:

To determine the short-term cumulative incidence and relative hazard of arterial thromboembolism in elderly patients with incident breast cancer.

MATERIALS AND METHODS:

Using the Surveillance Epidemiology and End Results-Medicare linked database, which includes approximately 28% of all patients diagnosed with cancer in the United States, we identified patients with a new primary diagnosis of breast cancer from 2002 through 2011. These patients were individually matched by age, sex, race, registry, and medical comorbidities to a group of Medicare enrollees without cancer, and each pair was followed through 2012. Validated diagnosis codes were used to identify a primary composite outcome of arterial thromboembolism defined as any ischemic stroke or myocardial infarction. Secondary outcomes included ischemic stroke alone and myocardial infarction alone. Cumulative incidence rates were calculated using competing risk survival statistics. The Gray test was used to compare rates between groups. The proportional hazard assumption was violated for the entirety of patient follow-up; therefore, Cox proportional hazard analysis was performed at discrete time points when the assumption was generally met.

RESULTS:

We identified 96,666 pairs of breast cancer patients and matched controls. Median age was 75 years and few cancers were advanced at diagnosis (12% stages 3/4). The 3-month cumulative incidence of arterial thromboembolism was 2.1% (95% confidence interval [CI] 2.0-2.2%) in cancer patients compared to 1.4% (95% CI 1.3-1.5%) in controls (hazard ratio [HR] 1.5, 95% CI 1.4-1.6, p<0.01). The short-term risk of each secondary outcome was heightened in the breast cancer group, although the relative hazard for myocardial infarction was higher than for ischemic stroke. The 3-month cumulative incidence of ischemic stroke was 1.3% (95% CI 1.2-1.4%) in cancer patients compared to 1.0% (95% CI 0.9-1.1%) in controls (HR 1.3, 95% CI 1.2-1.4, p<0.01), and the 3-month cumulative incidence of myocardial infarction was 0.9% (95% CI 0.8-0.9%) in cancer patients compared to 0.4% (0.4-0.5%) in controls (HR 2.0, 95% CI 1.8-2.3, p<0.01). Excess risks attenuated over time and were no longer present beyond 1 year.

CONCLUSIONS:

Patients with incident breast cancer face an increased short-term risk of ischemic stroke and myocardial infarction.

BMC ophthalmology

The efficacy and safety of varenicline nasal spray for the management of dry eye signs: a systematic review and meta-analysis

Review

作者: Bashrahil, Bader ; Alghamdi, Saeed ; Aldahlawi, Abdulaziz ; Taher, Nada ; Alzahrani, Ziyad ; Alnabihi, Ahmed ; Alkhathlan, Mohammed

Abstract:

Background:

Dry eye disease (DED) is caused by a persistently unstable tear film leading to ocular discomfort and is treated mainly with tear supplementation. There is emerging evidence that nicotinic acetylcholine receptor (nAChR) agonists (e.g., varenicline and simpinicline) nasal sprays are effective for DED. Our systematic review and meta-analysis assessed the efficacy and safety of varenicline nasal spray (VNS) for DED treatment.

Methods:

The Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases were searched. Only randomized controlled trials (RCTs) that evaluated the efficacy of VNS versus placebo were included. The efficacy endpoint was the mean change in the anesthetized Schirmer test score (STS), a measure of basal tear production, from baseline. The safety endpoints were serious adverse events (SAEs) and adverse events (AEs). The standardized mean difference (SMD) was used for continuous outcomes, while the risk ratio (RR) was used to demonstrate dichotomous variables. The certainty of the evidence was rated utilizing the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. The risk of bias assessment was conducted using the Revised Cochrane risk of bias tool for randomized trials.

Results:

Three RCTs (n = 1063) met the eligibility criteria. All RCTs had a low risk of bias. The meta-analysis found a statistically significant increase in the mean STS change from baseline on day 28. The pooled analysis found no significant difference between VNS and placebo in the frequency of SAEs and ocular AEs. However, VNS had a significant effect on developing nasal cavity-related AEs.

Conclusion:

VNS caused a highly significant improvement regarding the efficacy endpoint but caused an increased frequency of some nasal cavity-related AEs (i.e., cough and throat irritation). However, it caused neither SAEs nor ocular AEs. Included studies had a low risk of bias.

项与 OC-02 相关的新闻（医药）

2024-12-12

·Pharma CMC

远大医药引进2款治疗干眼症创新产品

12月11日，远大医药发布公告宣布与箕星药业达成产品引进战略合作协议。根据协议，在相关条件满足后，远大医药将获得用于治疗干眼症的全球首创创新产品酒石酸伐尼克兰鼻喷雾剂（OC-01）及OC-02（Simpinicline）鼻喷雾剂在大中华区（中国大陆、中国香港特别行政区、中国澳门特别行政区、台湾地区）的独家开发及商业化权益。据公告披露，OC-01和OC-02是两种高选择性的乙酰胆碱能受体激动剂，可通过启动三叉神经副交感神经通路，增加天然泪液的分泌，从而达到治疗干眼症的目的。根据OC-01的III期临床研究结果显示，与对照组相比，OC-01在改善干眼症患者泪液分泌方面显示出具有统计学和临床意义的显著改善，受试者的自然泪液分泌较基线明显增加（Schirmer评分较基线增加大于或等于10毫米的受试者比例显著占优），且安全性和耐受性良好。 OC-02在美国完成了针对干眼症的IIb期临床研究，结果显示产品能够促进泪膜产生，从而改善干眼症患者的体征和症状。 OC-01于2021年10月在美国获批上市，是目前全球首款且唯一一款获批治疗轻、中、重度干眼的无防腐剂、多剂量、无菌包装鼻喷雾剂；中国大陆方面，OC-01于2024年11月获得国家药监局批准上市。

上市批准临床3期

2024-12-11

·Insight数据库

远大医药引进两款干眼症全球首创新产品

12 月 11 日，远大医药宣布，近日已与与箕星药业达成产品引进战略合作协议。截图来源：公司公告根据协议，在相关条件满足后，远大医药将获得用于治疗干眼症的全球首创创新产品酒石酸伐尼克兰鼻喷雾剂 OC-01 及 OC-02 (Simpinicline) 鼻喷雾剂在大中华区 (中国大陆、中国香港特别行政区、中国澳门特别行政区、中国台湾地区) 的独家开发及商业化权益。此次战略合作将进一步深化远大医药在眼科领域的创新产品布局。 OC-01 和 OC-02 是两种高选择性的乙酰胆碱能受体激动剂，可通过启动三叉神经副交感神经通路，增加天然泪液的分泌，从而达到治疗干眼症的目的。 OC-01 于 2021 年 10 月在美国获批上市，是目前全球首款且唯一一款获批治疗轻、中、重度干眼的无防腐剂、多剂量、无菌包装鼻喷雾剂，并于 2024 年 11 月在国内获批上市。 OC-01 的 III 期临床研究结果显示，与对照组相比，OC-01 在改善干眼症患者泪液分泌方面显示出具有统计学和临床意义的显著改善，受试者的自然泪液分泌较基线明显增加（Schirmer 评分较基线增加大于或等于 10 毫米的受试者比例显著占优），且安全性和耐受性良好。 OC-02 在美国完成了针对干眼症的 IIb 期临床研究，结果显示产品能够促进泪膜产生，从而改善干眼症患者的体征和症状。封面来源：企业logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：vvy PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

上市批准临床2期临床3期

2024-12-11

·医药魔方Info

远大医药引进两款干眼症鼻喷雾剂，一款已上市

12月11日，远大医药集团发布公告称，已与箕星药业达成产品引进战略合作协议。根据协议，在相关条件满足后，远大医药将获得用于治疗干眼症的全球首创创新产品酒石酸伐尼克兰鼻喷雾剂（OC-01）及OC-02（Simpinicline）鼻喷雾剂（OC-02）在大中华区（中国大陆、中国香港特别行政区、中国澳门特别行政区、台湾地区）的独家开发及商业化权益，深化远大医药在眼科领域创新产品布局。 OC-01和OC-02是两种高选择性乙酰胆碱能受体激动剂，可通过启动三叉神经副交感神经通路增加天然泪液分泌治疗干眼症。OC-01的III期临床研究显示，与对照组相比，其在改善干眼症患者泪液分泌方面有显著改善且安全性和耐受性良好；OC-02在美国完成的IIb期临床研究显示产品能促进泪膜产生，改善患者体征和症状。产品注册方面，OC-01于2021年10月在美国获批上市，是目前全球首款且唯一一款获批治疗轻、中、重度干眼的无防腐剂、多剂量、无菌包装鼻喷雾剂。在中国大陆，OC-01于2024年11月获得中华人民共和国国家药品监督管理局批准上市；此外，OC-01于2023年2月在中国澳门特别行政区获批上市；于2023年4月作为进口临床急需药品，落地海南乐城医疗先行区；于2023年12月在香港大学深圳医院开出粤港澳大湾区的首张处方；于2024年11月在台湾地区获批上市。远大医药以眼科领域为重要战略发展方向，构建了 “专业化、全系列、多品种” 的创新药物产品体系，储备多款全球创新产品且取得重大研发进展，未来三年将有多款创新产品有望获批上市。如用于治疗蠕形螨睑缘炎的GPN01768（TP-03）已完成中国III期临床研究并准备递交上市申请；用于抗炎镇痛的GPN00833于2024年11月完成国内III期临床研究并达到临床终点；用于治疗翼状胬肉的GPN00153（CBT-001）于2024年3月完成中国III期临床研究首例患者入组给药；用于延缓儿童近视进展的GPN00884于2024年6月完成中国I期临床研究首例患者入组给药。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。精彩预告线上直播 ↑点击扫码，直达直播间↑

临床3期上市批准

100 项与 OC-02 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
干眼综合征	临床3期	中国	箕星药业科技（上海）有限公司	2022-08-12
新型冠状病毒感染	临床前	美国	Oyster Point Pharma, Inc.	2021-07-03

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03452397 (PEARL, Pubmed)	临床2期	干眼综合征	165	OC-02 SNS (0.11 mg)	構鏇範憲範簾憲艱齋衊(衊觸艱繭構鬱窪鬱艱簾) = 蓋淵網鏇淵憲獵製廠網蓋鏇衊齋遞鹽壓簾餘壓 (餘鹽憲憲艱蓋鬱鹽製鑰 )	-	2022-08-11
				OC-02 SNS (0.55 mg)	構鏇範憲範簾憲艱齋衊(衊觸艱繭構鬱窪鬱艱簾) = 壓衊膚餘鑰繭壓積齋範蓋鏇衊齋遞鹽壓簾餘壓 (餘鹽憲憲艱蓋鬱鹽製鑰 )
NCT03633461 (CTgov)	临床2期	干眼综合征	53	OC-02 (simpinicline) nasal spray (OC-02 (Simpinicline) Spray Spray, 11.1 mg/ml)	夢願膚範遞構窪糧遞簾(選製願糧鏇壓繭廠製網) = 鏇選鬱齋獵憲壓醖鬱選艱壓鬱顧醖積簾齋鑰願 (製觸遞獵鏇廠選顧鹹夢, 齋顧願蓋餘遞艱廠窪壓 ~ 廠選鑰壓積窪願蓋憲獵) 更多	-	2022-02-03
				Placebo (vehicle) nasal spray (Placebo)	夢願膚範遞構窪糧遞簾(選製願糧鏇壓繭廠製網) = 鹹餘範積顧夢淵膚選鬱艱壓鬱顧醖積簾齋鑰願 (製觸遞獵鏇廠選顧鹹夢, 築築網壓膚鑰蓋築衊獵 ~ 襯鏇壓鹽願淵廠顧糧鹹) 更多
NCT03452397 (PEARL, CTgov)	临床2期	干眼综合征	165	0.2 % hemigalactarate (0.11% free base) 0.2 % OC-02 Low Dose (1.1 mg/mL) (0.2 % Hemigalactarate (0.11% Free Base) 0.2 % OC-02 Low Dose (1.1 mg/mL))	鹹艱鹽選夢築廠顧窪鬱(簾積鑰壓網積鬱顧繭襯) = 積廠鹹鹹衊製憲鹹網範鏇選艱夢觸鏇艱選襯網 (築蓋積繭鏇襯鹹範製築, 餘廠淵廠範鏇蓋廠願艱 ~ 繭憲簾憲獵齋繭壓蓋襯) 更多	-	2021-12-14
				1.0 % hemigalactarate (0.11% free base) 1.0 % OC-02 Mid Dose (5.5 mg/mL) (1.0 % Hemigalactarate (0.11% Free Base) 1.0 % OC-02 Mid Dose (5.5 mg/mL))	鹹艱鹽選夢築廠顧窪鬱(簾積鑰壓網積鬱顧繭襯) = 遞繭蓋餘齋壓鏇餘範獵鏇選艱夢觸鏇艱選襯網 (築蓋積繭鏇襯鹹範製築, 蓋構獵鑰憲網艱顧選網 ~ 鏇襯窪膚積壓窪廠網築) 更多
RAINIER (Corporate Publications) 人工标引	临床2期	干眼综合征	53	OC-02	醖遞淵醖餘膚憲願齋壓(鏇簾繭觸範糧鏇淵觸膚) = 衊鹹積簾鹹齋餘願顧衊憲醖鏇鑰淵範廠構衊顧 (鹽艱衊鹹糧顧醖衊範夢 )	积极	2018-10-26
				Placebo	醖遞淵醖餘膚憲願齋壓(鏇簾繭觸範糧鏇淵觸膚) = 鏇網鏇淵淵餘壓觸憲壓憲醖鏇鑰淵範廠構衊顧 (鹽艱衊鹹糧顧醖衊範夢 )