预约演示
更新于：2024-12-25
Tropicamide
托吡卡胺
更新于：2024-12-25
概要
基本信息
在研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C17H20N2O2 |
InChIKeyBGDKAVGWHJFAGW-UHFFFAOYSA-N |
CAS号1508-75-4 |
关联
26
项与 托吡卡胺 相关的临床试验CTRI/2024/08/072980
To evaluate changes in hemodynamic parameters in hypertensive and nomotensive patients using intracameral injection of a mix Tropicamide 0.2 percentage . Phenylnephrine 0.31 percentage . Lidocaine 10 mg in patients undergoing cataract surgerv An interventional study - NIL
开始日期2024-09-09 |
申办/合作机构- |
ChiCTR2400084750
Comparison of the effects of pupil dilation and ciliary muscle paralysis of 1% tropicamide, 0.5% tropicamide and 1% cyclopentolate
开始日期2024-05-31 |
申办/合作机构- |
NCT06077682
Tropicamide Versus Cyclopentolate for Cycloplegic Refraction in Pediatric Patients With Esotropia: A Randomized Clinical Trial
The primary outcome of this study is to compare cyclopentolate 1% and tropicamide 1% for cycloplegic refractions in pediatric populations with esotropia. This will be a prospective double-blinded randomized clinical trial (RCT), multi-center, with randomized sequencing of cycloplegic agent; each patient received one agent at one visit, and the other agent in the next visit (2 different visits ≥ 1 week apart) within 3 months.
开始日期2023-09-01 |
申办/合作机构 The Islamic Hospital [+2] |
100 项与 托吡卡胺 相关的临床结果
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100 项与 托吡卡胺 相关的转化医学
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100 项与 托吡卡胺 相关的专利（医药）
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952
项与 托吡卡胺 相关的文献（医药）2025-02-01·JOURNAL FRANCAIS D OPHTALMOLOGIE
Optical coherence tomography (OCT) findings in patients with Parkinson's disease presenting to Farshchian Hospital (Sina) in 2019 compared to the normal population
Article
作者: Eslamighayour, A ; Ghiasian, M ; Mohamadrahimi, B ; Jiriaee, N ; Eslami, F
OBJECTIVE:
Parkinson's disease is the second most common disease of the central nervous system after Alzheimer's disease. Currently, no blood test or other laboratory tests are available to diagnose this condition. One of the practical methods in diagnosing and evaluating the progress of neurodegenerative diseases is the use of optical coherence tomography (OCT), with which it is possible to accurately measure the thickness of the layers of the retina, as well as the thickness and volume of the macula. The goal of this study was to determine the OCT findings in patients with Parkinson's disease compared to the normal population.
METHOD:
This study was conducted in 2019 at the Neurology Clinic of Farshchian Hospital, Hamadan (Iran). Sampling was performed based on the inclusion/exclusion criteria of the study and the required sample size. Patients referred to the Neurology Department of Farshchian Hospital were first examined by a neurologist, then referred to the ophthalmology clinic for a complete ophthalmological examination. OCT imaging was performed by an experienced, skilled optometrist after pupillary dilation with tropicamide drops. RNFL thickness, macula and fovea, and the measured macular volumes were recorded along with other information, including age, sex, disease duration, severity of disease symptoms, and drug use. Finally, the data were analyzed using SPSS version 22 statistical software.
FINDINGS:
A total of 103 individuals including 49 males (47.6%) and 54 females (52.4%) with a mean age of 70.66 years were examined. The subjects included two groups, patients (53 subjects) and control (50 subjects), who were matched in terms of age and gender distribution. The mean RNFL thickness and macular thickness and volume in the patient group were significantly lower than in the control group (P<0.05). There was an inverse relationship between the thickness of the RNFL and the macula with the duration of the disease and the severity of the disease symptoms (P<0.05).
CONCLUSION:
In this study, a significant decrease in RNFL thickness and macular thickness and volume was shown in patients with Parkinson's disease compared to the age- and sex-matched control group. It can be said that the changes in the macula and RNFL in Parkinson's disease and with progression of the disease are suitable markers for diagnosing and investigating the progression of Parkinson's disease.
2025-01-01·OPHTHALMOLOGY
Reversal of Pharmacologically Induced Mydriasis with Phentolamine Ophthalmic Solution
Article
作者: Sooch, Mina ; Evans, David ; Patel, Ronil ; Coleman, Drey ; Charizanis, Konstantinos ; Pepose, Jay S ; Withers, Barbara ; Brigell, Mitchell ; Jaber, Reda ; Lazar, Audrey ; Wirta, David ; Rahmani, Kavon
PURPOSE:
To evaluate the safety and efficacy of 0.75% phentolamine ophthalmic solution (POS), an α-adrenergic antagonist, in reversal of pharmacologically induced mydriasis.
DESIGN:
Two phase 3, multicenter, placebo-controlled, randomized, double-masked clinical trials in healthy participants.
PARTICIPANTS:
Five hundred fifty-three healthy 12- to 80-year-old participants were randomized 1:1 (MIRA 2) and 2:1 (MIRA 3) to receive either POS or placebo eye drops in both eyes.
METHODS:
Participants received POS or placebo administered 1 hour after mydriasis, induced by instillation of either 2.5% phenylephrine, 1% tropicamide, or 1% hydroxyamphetamine / 0.25% tropicamide.
MAIN OUTCOME MEASURES:
Percent of participants returning to within 0.2 mm of baseline pupil diameter in study eye 90 minutes after POS administration. Safety measures included treatment-emergent adverse events and tolerability measures, including conjunctival hyperemia.
RESULTS:
A total of 553 participants were randomized to treatment with placebo (n = 215) or POS (n = 338). A statistically significant greater percentage of participants treated with POS showed reversal of mydriasis at 90 minutes compared to placebo (MIRA 2: 48.9% vs. 6.6% [P < 0.0001]; MIRA 3: 58% vs. 6% [P < 0.0001]) and as early as 60 minutes (MIRA 2: 27.7% vs. 2.2% [P < 0.0001]; MIRA 3: 42% vs. 2% [P < 0.0001]). Between 28% and 34% of participants receiving placebo did not returned to baseline PD at 24 hours after pharmacologic dilation compared with 8% to 11% of patients treated with POS (P < 0.0001).
CONCLUSIONS:
Treatment with POS reduced PD within 60 to 90 minutes, with a statistically significant time savings of 5 to 6 hours to return to baseline PD compared with placebo. One or 2 drops of POS rapidly reversed mydriasis in all participants regardless of mydriatic agent or iris color. More participants receiving POS reported a benefit in the resolution of visual symptoms caused by pharmacologically induced mydriasis compared with placebo, with statistically significant differences noted as early as 1 hour. The safety profile was favorable, with the most common adverse effects being mild transient conjunctival hyperemia (11.2%), instillation site discomfort (10.9%), and dysgeusia (3.6%).
FINANCIAL DISCLOSURE(S):
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
2024-12-01·RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES
ASSESSMENT OF THE EFFECTS OF TWO COMMONLY USED MYDRIATICS ON THE MACULAR AND PERIPAPILLARY MICROVASCULAR SYSTEMS OF HEALTHY CHILDREN
Article
作者: Seyyar, Sevim Ayca ; Balyemez, Burçak ; Gürbostan Soysal, Gizem
Purpose::
To evaluate the effects of pupil dilation caused by topical applications of 2.5% phenylephrine and 0.5% tropicamide on retinal microvascularization using optical coherence tomography angiography (OCTA).
Methods::
Healthy children were included in this prospective observational study. Baseline OCTA measurements were taken for all children before dilatation. Then they were randomly divided into two groups, the tropicamide group given 0.5% tropicamide solution and the phenylephrine group given 2.5% phenylephrine solution. After dilation, OCTA images were taken for the second time from all children.
Results::
The effect of dilation using two different mydriatic agents caused a decrease in mean radial peripapillary capillary density (RPC-VD) and superior RPC-VD (P = 0.008 and P = 0.001). Remarkably, this reduction because of dilatation was also determined to be caused by the combined effect of both mydriatic agents (P = 0.016 and P = 0.013). Although phenylephrine showed a slightly greater decrease than tropicamide, the effects of the two mydriatic drugs were not superior to each other (P = 0.166 and P = 0.167).
Conclusion::
Dilation with 2.5% phenylephrine or 0.5% tropicamide significantly decreased mean RPC-VD and superior RPC-VD. Although there was no statistically significant difference between the two mydriatic agents, phenylephrine caused a greater reduction than tropicamide. This effect of dilation and phenylephrine on VD should be considered in studies using OCTA and focusing on peripapillary areas.
106
项与 托吡卡胺 相关的新闻（医药）2024-12-17
·医药地理
引用本文
张 涛, 黄 聪, 刘会文, 等．近视防控用阿托品眼用制剂的研究进展[J]．中国医药工业杂志, 2024, 55(12): 1603-1611．DOI：10.16522/j.cnki.cjph.2024.12.001
Research Progress of Atropine Ophthalmic Formulations for Myopia Prevention and Control
近视防控用阿托品眼用制剂的研究进展
张 涛1,2，黄 聪2，刘会文2，陆伟跃1*
(1. 复旦大学药学院，上海 201203；2. 拨康视云生物医药科技( 广州) 有限公司，广东广州 510663)
摘要
低浓度阿托品滴眼剂作为延缓青少年近视的眼用制剂，临床疗效已得到广泛认可，但已上市的硫酸阿托品水溶液型滴眼剂存在因pH 值低而导致的眼刺激性、制剂稳定性差和患者依从性差等问题。该文对目前在研和在售的硫酸阿托品眼用制剂的处方和制备工艺进行了文献调研和总结，分析了各种改善硫酸阿托品眼用制剂稳定性和依从性的技术方案特点和优劣势，以期为阿托品眼用制剂的优化提供一定的参考。
关键词
阿托品；近视；眼用制剂；滴眼剂；研究进展
文章节选
1 全球青少年近视防控的非手术方法概述
近视是全球性的公共健康问题。过去20 年，近视的发病率逐年增长，并且出现了低龄化趋势，亚洲地区近视儿童的增加尤为迅速。确切的近视发病机制尚不清楚，而目前的临床研究及流行病学调查结果提示，遗传、环境、学习压力以及对于电子产品的依赖等因素在近视发病及进展过程中起重要作用。
可用于防控青少年近视的非手术方法有如下几种。①行为干预：主要是增加户外活动和减少近距离用眼等，对预防近视的发生和减缓假性近视向近视的转换效果明显，可延缓近视进展。②框架眼镜：是矫正青少年近视的首选方式，可避免视疲劳，但普通框架眼镜不可控制近视程度的增长，对于高度近视以及散光、屈光参差近视患者的矫正效果并不理想，使用不当反而会使近视程度加深。③角膜塑形用硬性透气接触镜(orthokeratology lens，即OK 镜)：为Ⅲ类医疗器械，通过角膜塑形术进行视力矫正，可延缓青少年近视的发展，但个体差异使得配镜及护理费用较高，治疗效果还会随时间延长而减弱，且配戴过程存在适配不良、角膜上皮受损或感染的风险。另外，OK 镜佩戴者中，有色素环形成和角膜神经类型( 纤维线)改变等不良反应的报道。④多焦点软性角膜接触镜：验光、配镜比OK 镜简单，近视控制效果相似，但镜片设计差异较大，不同设计对镜片的偏位、矫正效果以及视功能恢复的影响不同，如果验配和使用不当，会引起眩光、光晕、视力模糊、视野扭曲、复视、头晕或微生物感染等并发症，影响佩戴者的生活质量和满意度。⑤口服药物：近视治疗药物的临床试验申请较少，目前有7-甲基黄嘌呤和核黄素等用于口服治疗近视的报道，但作用机制尚不明确。⑥滴眼剂：目前在研的控制近视程度增长的滴眼剂产品有阿托品、托吡卡胺、噻吗洛尔、哌仑西平和噻托溴铵滴眼剂等。其中， 低浓度阿托品滴眼剂的多项临床试验结果已证明，该药品可有效延缓青少年的近视。从2019 年开始，国家卫生健康委员会在《儿童青少年近视防控适宜技术指南》中明确，低浓度阿托品滴眼剂可有效延缓青少年近视进展。另外，低浓度阿托品滴眼剂也被欧洲眼科学会与国际近视合作机构、考克兰循证医学数据库推荐为效果仅次于行为干预、优于OK 镜和软性角膜接触镜的青少年近视控制方式。2024 年3 月5 日，沈阳兴齐眼药股份有限公司的0.01％硫酸阿托品滴眼液经NMPA批注上市。
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作者简介 ：
张 涛(1983—)，男，博士研究生，专业方向 ：生物与医药。
通信作者 ：
陆伟跃(1960—)，男，教授，从事药物靶向策略及递药系统研究。
E-mail：wylu@shmu.edu.cn
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每周药品注册获批数据，分门别类呈现，一目了然。(12.2-12.8）
新药上市申请药品名称企业注册分类受理号信诺拉生酯胶囊上海生诺医药科技有限公司1CXHS2300027磷酸盛格列汀片盛世泰科生物医药技术(苏州)股份有限公司1CXHS2300022依达拉奉右莰醇舌下片先声药业有限公司2.2CXHS2300058氟唑帕利胶囊江苏恒瑞医药股份有限公司2.4CXHS2400032甲磺酸阿帕替尼片江苏恒瑞医药股份有限公司2.4CXHS2400031甲磺酸阿帕替尼片江苏恒瑞医药股份有限公司2.4CXHS2400030呋喹替尼胶囊和记黄埔医药(上海)有限公司2.4CXHS2400024呋喹替尼胶囊和记黄埔医药(上海)有限公司2.4CXHS2400023信迪利单抗注射液信达生物制药(苏州)有限公司2.2CXSS2400038斯鲁利单抗注射液上海复宏汉霖生物制药有限公司2.2CXSS2300094
新药临床申请药品名称企业注册分类受理号[177Lu]Lu-XT117注射液北京先通国际医药科技股份有限公司1CXHL2401036BGB-53038胶囊百济神州(苏州)生物科技有限公司1CXHL2401031BGB-53038胶囊百济神州(苏州)生物科技有限公司1CXHL2401030BGB-53038胶囊百济神州(苏州)生物科技有限公司1CXHL2401029HRS-4729注射液福建盛迪医药有限公司1CXHL2401028HRS-4729注射液福建盛迪医药有限公司1CXHL2401027HRS-4357注射液天津恒瑞医药有限公司1CXHL2401018ZL-85FA片成都赜灵生物医药科技有限公司1CXHL2401009ZL-85FA片成都赜灵生物医药科技有限公司1CXHL2401008FHND6091胶囊江苏正大丰海制药有限公司1CXHL2401007FHND6091胶囊江苏正大丰海制药有限公司1CXHL2401006Kylo-12注射液厦门甘宝利生物医药有限公司1CXHL2401011HSK46575片西藏海思科制药有限公司1CXHL2400992HSK46575片西藏海思科制药有限公司1CXHL2400991HSK46575片西藏海思科制药有限公司1CXHL2400990IN10018片应世生物科技(上海)有限公司1CXHL2401004IN10018片应世生物科技(上海)有限公司1CXHL2401003JMKX001899片浙江杭煜制药有限公司1CXHL2401002JMKX001899片浙江杭煜制药有限公司1CXHL2401001Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401000Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2400999Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2400998Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2400997BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2400996BGB-16673片百济神州(苏州)生物科技有限公司1CXHL2400995MWN109注射液上海民为生物技术有限公司1CXHL2401005JMKX003676片浙江杭煜制药有限公司1CXHL2400925JMKX003676片浙江杭煜制药有限公司1CXHL2400924JMKX003676片浙江杭煜制药有限公司1CXHL2400921注射用JMX-2006南京恒生制药有限公司2.2CXHL2401017SMF-211江西施美药业股份有限公司2.3CXHL2400981四价肠道病毒灭活疫苗(Vero细胞)北京科兴生物制品有限公司1.4CXSL2400619四价流感病毒裂解疫苗(MDCK细胞)艾美诚信生物制药有限公司2.2CXSL2400629RGB-5088胰岛细胞注射液杭州瑞普晨创科技有限公司1CXSL2400698KJ015注射液(皮下注射)上海宝济药业股份有限公司1CXSL2400672HLX22单抗注射液上海复宏汉霖生物技术股份有限公司1CXSL2400663注射用SHR-A1811苏州盛迪亚生物医药有限公司1CXSL2400652注射用HLX43上海复宏汉霖生物技术股份有限公司1CXSL2400668注射用SHR-4602苏州盛迪亚生物医药有限公司1CXSL2400662MG-K10人源化单抗注射液上海麦济生物技术有限公司1CXSL2400664注射用SHR-1501上海恒瑞医药有限公司1CXSL2400642注射用FH-006江苏恒瑞医药股份有限公司1CXSL2400637HC022注射液上海宏成药业有限公司1CXSL2400645注射用SKB500四川科伦博泰生物医药股份有限公司1CXSL2400644JS019注射液北京恩瑞尼生物科技股份有限公司1CXSL2400641IBI3009信达生物制药(苏州)有限公司1CXSL2400648重组安菲博肽注射液兆科药业(合肥)有限公司1CXSL2400638重组安菲博肽注射液兆科药业(合肥)有限公司1CXSL2400639ZL-1102凝胶再鼎医药(上海)有限公司1CXSL2400646SHR-2173注射液广东恒瑞医药有限公司1CXSL2400643ZL-1102凝胶再鼎医药(上海)有限公司1CXSL2400647MC-1-50细胞制剂重庆精准生物技术有限公司1CXSL2400632HF50杭州高田生物医药有限公司1CXSL2400621外用RGL-2102上海瑞宏迪医药有限公司1CXSL2400615RG002注射液仁景(苏州)生物科技有限公司1CXSL2400614TAEST16001注射液香雪生命科学技术(广东)有限公司1CXSL2400618靶向CD19和CD22 的嵌合抗原受体自体T细胞注射液上海医药集团生物治疗技术有限公司1CXSL2400604GKL-006注射液北京基因启明生物科技有限公司1CXSL2400602注射用VRT106广州威溶特医药科技有限公司1CXSL2400590阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2400651SHR-8068注射液苏州盛迪亚生物医药有限公司2.2CXSL2400654阿得贝利单抗注射液上海盛迪医药有限公司2.2CXSL2400640重组人透明质酸酶注射液北京诺博特生物科技有限公司2.4CXSL2400670重组人透明质酸酶注射液北京诺博特生物科技有限公司2.4CXSL2400669
仿制药申请药品名称企业注册分类受理号米诺地尔搽剂乐福思健康产业股份公司3CYHS2400414米诺地尔搽剂乐福思健康产业股份公司3CYHS2400412米诺地尔搽剂乐福思健康产业股份公司3CYHS2400410盐酸多巴酚丁胺注射液陕西顿斯制药有限公司3CYHS2302377美沙拉秦缓释胶囊北京福元医药股份有限公司3CYHS2302305盐酸异丙肾上腺素注射液成都米子生物医药科技有限公司3CYHS2302299重酒石酸去甲肾上腺素注射液武汉久安药业有限公司3CYHS2302220氯化钾注射液黑龙江博宇制药有限公司3CYHS2302209注射用尼可地尔海南皇隆制药股份有限公司3CYHS2302095注射用尼可地尔海南皇隆制药股份有限公司3CYHS2302094甲硫酸新斯的明注射液东阳祥昇医药科技有限公司3CYHS2302055甲硫酸新斯的明注射液东阳祥昇医药科技有限公司3CYHS2302054盐酸甲氧氯普胺注射液安徽长江药业有限公司3CYHS2301976盐酸丙卡特罗口服溶液江苏万高药业股份有限公司3CYHS2301818间苯三酚口崩片浙江高跖医药科技股份有限公司3CYHS2301786盐酸甲氧氯普胺注射液东阳祥昇医药科技有限公司3CYHS2301782地高辛注射液江苏联环药业股份有限公司3CYHS2301735间苯三酚口崩片湖南先施制药有限公司3CYHS2301727氯化钾注射液北京柏雅联合药物研究所有限公司3CYHS2301723盐酸甲氧氯普胺注射液西洲医药科技(浙江)有限公司3CYHS2301711酮咯酸氨丁三醇注射液福建天泉药业股份有限公司3CYHS2301620美索巴莫注射液福安药业集团庆余堂制药有限公司3CYHS2301612呋塞米注射液武汉久安药业有限公司3CYHS2301607呋塞米注射液武汉久安药业有限公司3CYHS2301606氯化钾注射液成都米子生物医药科技有限公司3CYHS2301596氯化钾注射液成都欣捷高新技术开发股份有限公司3CYHS2301578二羟丙茶碱注射液森淼(山东)药业有限公司3CYHS2301556氯化钾注射液南京恩泰医药科技有限公司3CYHS2301547帕拉米韦注射液山西阳和医药技术有限公司3CYHS2301504盐酸艾司洛尔注射液湖南赛隆药业(长沙)有限公司3CYHS2301503盐酸左沙丁胺醇雾化吸入溶液海南斯达制药有限公司3CYHS2301485二羟丙茶碱注射液浙江和泽医药科技股份有限公司3CYHS2301480法莫替丁注射液南京康发生物科技有限公司3CYHS2301437氟尿嘧啶注射液湖南赛隆药业(长沙)有限公司3CYHS2301428重酒石酸卡巴拉汀口服液百善科技(湖州)有限公司3CYHS2301390吲哚布芬片北京诚济制药股份有限公司3CYHS2301349注射用尼可地尔重庆德诚永道医药有限公司3CYHS2301328硫酸特布他林口服溶液成都利尔药业有限公司3CYHS2301327硫酸特布他林口服溶液成都利尔药业有限公司3CYHS2301326帕拉米韦注射液湖北民康药业集团有限公司3CYHS2301271注射用盐酸罗沙替丁醋酸酯海南倍特药业有限公司3CYHS2301212盐酸甲哌卡因注射液济南辰欣医药科技有限公司3CYHS2301195氯化钾颗粒山西普德药业有限公司3CYHS2301126缩宫素注射液安徽百奥药业有限公司3CYHS2301105醋酸维持液石家庄四药有限公司3CYHS2301104醋酸维持液石家庄四药有限公司3CYHS2301103巴氯芬口服溶液江苏天士力帝益药业有限公司3CYHS2301070氨溴特罗口服溶液江西仁齐制药有限公司3CYHS2301066异烟肼注射液嘉实(湖南)医药科技有限公司3CYHS2301054托拉塞米注射液海南斯达制药有限公司3CYHS2301009托拉塞米注射液海南斯达制药有限公司3CYHS2301008聚乙烯醇滴眼液上海阿尔福斯医药科技有限公司3CYHS2300992磷酸奥司他韦干混悬剂北京斯利安药业有限公司3CYHS2300958二羟丙茶碱注射液安徽长江药业有限公司3CYHS2300942重酒石酸间羟胺注射液河南蓝图制药有限公司3CYHS2300889氨溴特罗口服溶液海南天盛保和生物科技有限公司3CYHS2300745奥沙利铂注射液贵州阜康仁制药有限公司3CYHS2300670氨溴特罗口服溶液南京卡文迪许生物工程技术有限公司3CYHS2300568注射用吲哚菁绿南京亚东启天药业有限公司3CYHS2300560己酮可可碱注射液江苏慧聚药业股份有限公司3CYHS2300543达格列净二甲双胍缓释片南京正大天晴制药有限公司3CYHS2300499达格列净二甲双胍缓释片南京正大天晴制药有限公司3CYHS2300498氨溴特罗口服溶液浙江康润制药有限公司3CYHS2300383氨溴特罗口服溶液浙江康润制药有限公司3CYHS2300382氨己烯酸口服溶液用散远大医药(中国)有限公司3CYHS2300027国;CYHS2300027羧甲司坦口服溶液北京康晟百春生物科技有限公司3CYHS2202114国;CYHS2202114腺苷注射液北京布霖生物科技有限公司3CYHS2202062国;CYHS2202062利奈唑胺干混悬剂广州一品红制药有限公司3CYHS2202052国;CYHS2202052卡络磺钠注射液成都倍特药业股份有限公司3CYHS2201632国;CYHS2201632卡络磺钠注射液成都倍特药业股份有限公司3CYHS2201631国;CYHS2201631卡络磺钠注射液成都倍特药业股份有限公司3CYHS2201630国;CYHS2201630注射用盐酸多西环素海南普利制药股份有限公司3CYHS2201636国;CYHS2201636注射用盐酸多西环素海南普利制药股份有限公司3CYHS2201635国;CYHS2201635腺苷注射液华夏生生药业(北京)有限公司3CYHS2201223国;CYHS2201223氟比洛芬钠滴眼液武汉先路医药科技股份有限公司3CYHS2200829国;CYHS2200829磷酸奥司他韦干混悬剂广东万方药业科技有限公司3CYHS2200236国;CYHS2200236注射用头孢米诺钠山东宜和生物医药科技有限公司4CYHS2400781磷酸奥司他韦胶囊浙江普洛康裕制药有限公司4CYHS2400689哌柏西利片石药集团欧意药业有限公司4CYHS2400665氧(液态)天津盈德气体有限公司4CYHS2400629磷酸奥司他韦胶囊遂成药业股份有限公司4CYHS2400588磷酸奥司他韦胶囊遂成药业股份有限公司4CYHS2400586磷酸奥司他韦胶囊遂成药业股份有限公司4CYHS2400585盐酸罗匹尼罗缓释片植恩生物技术股份有限公司4CYHS2400314罗沙司他胶囊重庆煜洋药业有限公司4CYHS2303610阿昔莫司胶囊浙江高跖医药科技股份有限公司4CYHS2303120注射用盐酸地尔硫䓬舒美奇成都生物科技有限公司4CYHS2303042马来酸氟伏沙明片湖南省湘中制药有限公司4CYHS2303021盐酸氮斯汀滴眼液合肥华威药业有限公司4CYHS2302951磷酸特地唑胺片石药集团中诺药业(石家庄)有限公司4CYHS2302958马来酸氟伏沙明片山东京卫制药有限公司4CYHS2302834硝酸异山梨酯注射液安徽誉恒生物科技有限公司4CYHS2302801枸橼酸坦度螺酮片山东京卫制药有限公司4CYHS2302794枸橼酸坦度螺酮片山东京卫制药有限公司4CYHS2302793依折麦布片江苏德源药业股份有限公司4CYHS2302773盐酸贝尼地平片重庆华邦制药有限公司4CYHS2302718地夸磷索钠滴眼液浙江尖峰药业有限公司4CYHS2302723普拉洛芬滴眼液苏州欧康维视生物科技有限公司4CYHS2302684吸入用硫酸沙丁胺醇溶液山东新时代药业有限公司4CYHS2302678吸入用乙酰半胱氨酸溶液陕西丽彩药业有限公司4CYHS2302648硫酸羟氯喹片西安海欣制药有限公司4CYHS2302632西他沙星片浙江麒正药业有限公司4CYHS2302628乙酰半胱氨酸泡腾片江苏和晨药业有限公司4CYHS2302616注射用伏立康唑陕西博森生物制药股份集团有限公司4CYHS2302591磷酸奥司他韦胶囊天方药业有限公司4CYHS2302571阿戈美拉汀片深圳市泛谷药业股份有限公司4CYHS2302531阿帕他胺片齐鲁制药(海南)有限公司4CYHS2302520精氨酸培哚普利片杭州仟源保灵药业有限公司4CYHS2302479精氨酸培哚普利片杭州仟源保灵药业有限公司4CYHS2302478左卡尼汀口服溶液江苏百奥信康医药科技有限公司4CYHS2302472普伐他汀钠片北京柏雅联合药物研究所有限公司4CYHS2302458尼莫地平注射液成都倍特药业股份有限公司4CYHS2302461普拉洛芬滴眼液圣嘉(滨海)生物医药科技有限公司4CYHS2302440阿司匹林肠溶片仁合益康集团有限公司4CYHS2302409马来酸氟伏沙明片安徽省先锋制药有限公司4CYHS2302391马来酸氟伏沙明片安徽省先锋制药有限公司4CYHS2302390尼可地尔片东阳祥昇医药科技有限公司4CYHS2302379间苯三酚注射液福建天泉药业股份有限公司4CYHS2302371亚叶酸钙注射液石家庄荣雾迪医药科技有限公司4CYHS2302359骨化三醇软胶囊湖南银泽华浩生物科技有限公司4CYHS2302334二甲双胍维格列汀片(Ⅱ)宁波美诺华天康药业有限公司4CYHS2302306富马酸福莫特罗吸入溶液合肥国药诺和药业有限公司4CYHS2302287阿戈美拉汀片杭州领业医药科技有限公司4CYHS2302278卡前列素氨丁三醇注射液北京仁众药业有限公司4CYHS2302262比索洛尔氨氯地平片福建海西新药创制股份有限公司4CYHS2302208地夸磷索钠滴眼液国药集团三益药业(芜湖)有限公司4CYHS2302234马来酸阿伐曲泊帕片山东良福制药有限公司4CYHS2302166替米沙坦氨氯地平片山西德元堂药业有限公司4CYHS2302154溴莫尼定噻吗洛尔滴眼液山东威智百科药业有限公司4CYHS2302136布洛芬混悬滴剂江苏万高药业股份有限公司4CYHS2302104铝碳酸镁咀嚼片江右制药(常德)有限公司4CYHS2302099莫匹罗星软膏珠海联邦制药股份有限公司中山分公司4CYHS2302064哌柏西利片南京正大天晴制药有限公司4CYHS2302061哌柏西利片南京正大天晴制药有限公司4CYHS2302060硝苯地平控释片山东新时代药业有限公司4CYHS2302043氯雷他定糖浆合肥远志医药科技开发有限公司4CYHS2302039恩格列净片湖南迪诺制药股份有限公司4CYHS2302022曲伏前列素滴眼液兆科(广州)眼科药物有限公司4CYHS2302009苯磺酸氨氯地平片吉林敖东药业集团延吉股份有限公司4CYHS2301986曲伏噻吗滴眼液兆科(广州)眼科药物有限公司4CYHS2301974盐酸伐地那非片山东海雅医药科技有限公司4CYHS2301955达格列净片浙江华义制药有限公司4CYHS2301953达格列净片浙江华义制药有限公司4CYHS2301952替米沙坦氨氯地平片康缘华威医药有限公司4CYHS2301967注射用头孢他啶阿维巴坦钠海南海灵化学制药有限公司4CYHS2301941瑞巴派特片苏州旺山旺水生物医药股份有限公司4CYHS2301934注射用头孢唑肟钠陕西东科制药有限责任公司4CYHS2301918注射用头孢唑肟钠陕西东科制药有限责任公司4CYHS2301917瑞巴派特片北京金城泰尔制药有限公司4CYHS2301916硫酸镁钠钾口服用浓溶液丽珠集团丽珠制药厂4CYHS2301893氢溴酸伏硫西汀片杭州和康药业有限公司4CYHS2301881阿戈美拉汀片重庆华森制药股份有限公司4CYHS2301877硫辛酸注射液江苏开元药业有限公司4CYHS2301872盐酸达泊西汀片齐鲁制药有限公司4CYHS2301837熊去氧胆酸胶囊宜昌人福药业有限责任公司4CYHS2301832罗库溴铵注射液中玉制药(海口)有限公司4CYHS2301828钆特酸葡胺注射液山东新时代药业有限公司4CYHS2301817钆特酸葡胺注射液山东新时代药业有限公司4CYHS2301816钆特酸葡胺注射液山东新时代药业有限公司4CYHS2301815阿普米司特片常州制药厂有限公司4CYHS2301812阿普米司特片常州制药厂有限公司4CYHS2301811阿普米司特片常州制药厂有限公司4CYHS2301810盐酸罗匹尼罗缓释片杭州和泽坤元药业有限公司4CYHS2301805卡铂注射液吉斯美(武汉)制药有限公司4CYHS2301789钆布醇注射液常州四药制药有限公司4CYHS2301788氧氟沙星滴耳液山东光明药业有限公司4CYHS2301752卡贝缩宫素注射液成都诺和晟鸿生物制药有限公司4CYHS2301732盐酸奥布卡因滴眼液苏州欧康维视生物科技有限公司4CYHS2301731氯沙坦钾氢氯噻嗪片宁波科尔康美诺华药业有限公司4CYHS2301692盐酸氟西汀胶囊江西施美药业股份有限公司4CYHS2301682注射用氯诺昔康福安药业集团湖北人民制药有限公司4CYHS2301667玻璃酸钠滴眼液华熙生物科技股份有限公司4CYHS2301663盐酸坦索罗辛缓释胶囊昆明积大制药股份有限公司4CYHS2301617碘佛醇注射液成都倍特药业股份有限公司4CYHS2301602碘佛醇注射液成都倍特药业股份有限公司4CYHS2301601马来酸阿伐曲泊帕片上海迪赛诺医药集团股份有限公司4CYHS2301559碳酸司维拉姆片国药集团致君(深圳)坪山制药有限公司4CYHS2301555间苯三酚注射液湖北午时医药研究院有限公司4CYHS2301535盐酸多柔比星脂质体注射液南京绿叶制药有限公司4CYHS2301507阿普米司特片广东迈恒医药研发有限公司4CYHS2301478阿普米司特片广东迈恒医药研发有限公司4CYHS2301477阿普米司特片广东迈恒医药研发有限公司4CYHS2301476布洛芬缓释胶囊南京华兴医药科技有限公司4CYHS2301450氨甲环酸注射液广州泽盛药业科技有限公司4CYHS2301436氨甲环酸注射液广州泽盛药业科技有限公司4CYHS2301435氨甲环酸注射液广州泽盛药业科技有限公司4CYHS2301434西格列汀二甲双胍片(II)浙江英格莱制药有限公司4CYHS2301433丙戊酸钠口服溶液安徽海斯美医药有限公司4CYHS2301421复方聚乙二醇电解质散(III)安徽省先锋制药有限公司4CYHS2301384乳果糖口服溶液海南斯达制药有限公司4CYHS2301323硫酸镁钠钾口服用浓溶液南京知和医药科技有限公司4CYHS2301299阿奇霉素干混悬剂迪沙药业集团有限公司4CYHS2301207异氟烷山东新时代药业有限公司4CYHS2301172异氟烷山东新时代药业有限公司4CYHS2301171吗啉硝唑氯化钠注射液山东齐都药业有限公司4CYHS2301112非诺贝特酸胆碱缓释胶囊鲁南贝特制药有限公司4CYHS2301088非诺贝特酸胆碱缓释胶囊鲁南贝特制药有限公司4CYHS2301087培哚普利氨氯地平片(III)江苏万高药业股份有限公司4CYHS2300948舒更葡糖钠注射液弘和制药有限公司4CYHS2300937左氧氟沙星滴眼液上海阿尔福斯医药科技有限公司4CYHS2300873盐酸莫西沙星氯化钠注射液湖北长联杜勒制药有限公司4CYHS2300870舒更葡糖钠注射液中国大冢制药有限公司4CYHS2300867注射用唑来膦酸浓溶液岳阳新华达制药有限公司4CYHS2300851二甲双胍恩格列净片(V)杭州云柏医药科技有限公司4CYHS2300815二甲双胍恩格列净片(I)杭州云柏医药科技有限公司4CYHS2300814甲磺酸仑伐替尼胶囊江苏康缘药业股份有限公司4CYHS2300794达格列净片浙江华海药业股份有限公司4CYHS2300694达格列净片浙江华海药业股份有限公司4CYHS2300693乳果糖口服溶液黑龙江中桂制药有限公司4CYHS2300690乳果糖口服溶液黑龙江中桂制药有限公司4CYHS2300689甲磺酸艾立布林注射液成都西岭源药业有限公司4CYHS2300657地诺孕素片博瑞制药(苏州)有限公司4CYHS2300580注射用丁二磺酸腺苷蛋氨酸海南倍特药业有限公司4CYHS2300451吗啉硝唑氯化钠注射液南京卡文迪许生物工程技术有限公司4CYHS2300474ω-3脂肪酸乙酯90软胶囊扬子江药业集团有限公司4CYHS2300357奥美沙坦酯氢氯噻嗪片宁波科尔康美诺华药业有限公司4CYHS2300248碘比醇注射液重庆圣华曦药业股份有限公司4CYHS2300167碘比醇注射液重庆圣华曦药业股份有限公司4CYHS2300166伊布替尼胶囊北京海步医药科技有限公司4CYHS2300103注射用丁二磺酸腺苷蛋氨酸重庆药友制药有限责任公司4CYHS2300037国;CYHS2300037吗啉硝唑氯化钠注射液成都国为生物医药有限公司4CYHS2202045国;CYHS2202045盐酸莫西沙星氯化钠注射液河北凯威恒诚制药有限公司4CYHS2201999国;CYHS2201999复方托吡卡胺滴眼液南京恒道医药科技股份有限公司4CYHS2201645国;CYHS2201645盐酸多奈哌齐片宝龙药业有限公司4CYHS2201419国;CYHS2201419屈螺酮炔雌醇片南通联亚药业股份有限公司4CYHS2200411国;CYHS2200411盐酸多奈哌齐片保定天浩制药有限公司4CYHS2101423国;CYHS2101423盐酸多奈哌齐片泰荣(福建)药业有限公司4CYHS2101184国;CYHS2101184马来酸阿法替尼片甘肃兰药药业有限公司4CYHS2101074国;CYHS2101074马来酸阿法替尼片甘肃兰药药业有限公司4CYHS2101073国;CYHS2101073盐酸西替利嗪滴眼液浙江莎普爱思药业股份有限公司3CYHL2400186利多卡因凝胶贴膏北京阳光诺和药物研究股份有限公司4CYHL2400192琥珀酰明胶注射液南京正大天晴制药有限公司4CYHL2400187吸附破伤风疫苗艾美坚持生物制药有限公司3.3CXSL2400596
进口申请药品名称企业注册分类受理号Odevixibat胶囊Albireo AB5.1JXHS2400025Odevixibat胶囊Albireo AB5.1JXHS2400024Odevixibat胶囊Albireo AB5.1JXHS2400023Odevixibat胶囊Albireo AB5.1JXHS2400022普托马尼片Mylan Ireland Limited5.1JXHS2300120多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(13%)电解质注射液Fresenius Kabi AB5.1JXHS2300093多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(13%)电解质注射液Fresenius Kabi AB5.1JXHS2300092多种油脂肪乳(C6-24)/氨基酸(16)/葡萄糖(13%)电解质注射液Fresenius Kabi AB5.1JXHS2300091注射用亚西瑞来Merck Sharp & Dohme B.V.5.1JXHS2300066注射用亚西瑞来Merck Sharp & Dohme B.V.5.1JXHS2300065倍氯米松福莫特罗粉吸入剂Chiesi Farmaceutici S.p.A.5.1JXHS2300060注射用芦比替定PharmaMar AG5.1JXHS2300049沙芬酰胺片Zambon S.p.A.5.1JXHS2200035国;JXHS2200035沙芬酰胺片Zambon S.p.A.5.1JXHS2200034国;JXHS2200034帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSS2300013钆特酸葡胺注射液Joint Stock Company “FARMAK”5.2JYHS2300001泊沙康唑肠溶片Hetero Labs Limited5.2JYHS2200053国;JYHS2200053苹果酸舒尼替尼胶囊Dr. Reddy's Laboratories Ltd.5.2JYHS2200003国;JYHS2200003达比加群酯胶囊印度熙德隆制药有限公司5.2JYHS2000002国;JYHS2000002达比加群酯胶囊印度熙德隆制药有限公司5.2JYHS2000003国;JYHS2000003达比加群酯胶囊印度熙德隆制药有限公司5.2JYHS2000006国;JYHS2000006E7386Eisai Co., Ltd.1JXHL2400237E7386Eisai Co., Ltd.1JXHL2400236E7386Eisai Co., Ltd.1JXHL2400235GDC-0077F. Hoffmann-La Roche Ltd.1JXHL2400226GDC-0077F. Hoffmann-La Roche Ltd.1JXHL2400225AMG 193Amgen Inc.1JXHL2400228AMG 193Amgen Inc.1JXHL2400227AMG 193Amgen Inc.1JXHL2400231AMG 193Amgen Inc.1JXHL2400230AMG 193Amgen Inc.1JXHL2400224AMG 193Amgen Inc.1JXHL2400223AMG 193Amgen Inc.1JXHL2400233AMG 193Amgen Inc.1JXHL2400232Lazertinib片Janssen Research & Development, LLC2.4JXHL240022920价肺炎球菌多糖结合疫苗Pfizer Europe MA EEIG3.1JXSL2400166MEDI5752AstraZeneca AB1JXSL2400186AZD2936AstraZeneca AB1JXSL2400184MEDI5752AstraZeneca AB1JXSL2400185PF-08046047Seagen Inc.1JXSL2400182AZD2936AstraZeneca AB1JXSL2400174DS-7300aDaiichi Sankyo, Inc.1JXSL2400175ABBV-706注射用冻干粉AbbVie Inc.1JXSL2400179AZD2936AstraZeneca AB1JXSL2400173MEDI5752AstraZeneca AB1JXSL2400178Amivantamab注射液(皮下注射)Janssen Research & Development, LLC2.1JXSL2400176Amivantamab注射液(皮下注射)Janssen Research & Development, LLC2.1JXSL2400177DS-8201aASTRAZENECA AB2.2JXSL2400183
中药相关申请药品名称企业注册分类受理号MYL软膏马应龙药业集团股份有限公司1.1CXZL2400059MYL软膏马应龙药业集团股份有限公司1.1CXZL2400058MYL软膏马应龙药业集团股份有限公司1.1CXZL2400057MYL软膏马应龙药业集团股份有限公司1.1CXZL2400056四仙颗粒四川省中医药科学院1.1CXZL2400053金蚕颗粒四川省中医药科学院1.1CXZL2400051黄蛭益肾胶囊雷允上药业集团有限公司2.3CXZL2400054
注：橙色字体部分结论为不批准或收到通知件；
申请上市临床申请
2024-11-12
Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for interim analysis this quarter Commenced the manufacture of registration batches of Mydcombi in its second generation Optejet device Announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain following ocular surgery Appointed Andrew Jones as Chief Financial Officer Company to host conference call and webcast today, November 12th, at 4:30 pm ET NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform, today announced its financial and operating results for the third quarter ended September 30, 2024. Third Quarter 2024 and Recent Business Developments Advanced the Phase 3 CHAPERONE study of MicroPine for pediatric progressive myopia with plans to conduct an interim analysis this quarter. External sources have valued the myopia market at over $3.0 billion annually in the U.S. and China.Announced the U.S. launch and commercial availability of clobetasol propionate ophthalmic suspension 0.05%, which is FDA approved for the treatment of post-operative inflammation and pain following ocular surgery.Announced collaboration agreements with Formosa Pharmaceuticals, Senju Pharmaceutical Co., Ltd. and SGN Nanopharma to develop novel therapeutics for use with Eyenovia’s Optejet® dispenser as potential treatments for dry eye disease, estimated to be a $5 billion global addressable market.Commenced the manufacture of registration batches of Mydcombi in its second generation Optejet device, a key step in the FDA approval process for its state-of-the-art Gen-2 Optejet dispensing platform.Reported training and shipping Mydcombi to 230 new offices from April through September 30th,2024.Appointed Andrew Jones as Chief Financial Officer.Raised combined net proceeds of $10.7 million. Michael Rowe, Chief Executive Officer, commented, “We achieved another significant commercial milestone during the third quarter with the U.S. launch of clobetasol, the first new ocular steroid approved in over 15 years. Clobetasol perfectly complements our mydriasis product, Mydcombi, and allows us to further leverage our sales force while adding significant value to eye doctors and surgeons. We also experienced accelerating sales momentum with Mydcombi, now having reached 230 offices as of September 30th. “We also took a meaningful step forward in the development of our Gen-2 Optejet device with the commencement of manufacture of registration batches, with Mydcombi as our lead product. We look forward to submitting for FDA approval of this advanced technology with Mydcombi in 2025, and a possible approval in 2026, if successful. “Regarding MicroPine, which we are developing for pediatric progressive myopia, we are preparing for an interim analysis of the Phase 3 CHAPERONE data this quarter that, if successful, we expect will meaningfully accelerate its remaining development path. We also executed several co-development agreements to evaluate novel therapeutics in our Optejet dispenser as potential treatments for dry eye disease. Together, these indications represent multi-billion-dollar addressable markets in the U.S. alone.” “With two differentiated commercial products, another in late Phase 3 development, multiple opportunities in dry eye, and the advanced Gen-2 Optejet technology platform, I believe we are creating a foundation from which we can drive significant growth and value creation in the months and years to come,” Mr. Rowe concluded. Third Quarter 2024 Financial Review For the third quarter of 2024, net loss was approximately $7.9 million, or $0.11 per share, as compared to a net loss of $7.3 million, or $0.18 per share, for the third quarter of 2023. Research and development expenses totaled approximately $3.5 million for the third quarter of 2024, which was relatively consistent with $3.6 million reported for the third quarter of 2023. For the third quarter of 2024, selling, general and administrative expenses were approximately $3.7 million, compared to $2.9 million for the third quarter of 2023, an increase of approximately 27.3% reflecting the establishment of the Company’s sales force in 2024. Total operating expenses for the third quarter of 2024 were approximately $7.2 million, compared to approximately $6.5 million for the third quarter of 2023. This represents an increase of approximately 10.6%. The third quarter 2024 operating expense figure includes approximately $1.2 million of non-cash expenses. As of September 30, 2024, the Company’s unrestricted cash and cash equivalents were approximately $7.2 million. Eyenovia continues to evaluate a range of options to secure long-term financing. Conference Call and Webcast The conference call is scheduled to begin at 4:30 pm ET today, November 12th. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international), and reference conference ID 13748714. To access the Call me™ feature, which avoids having to wait for an operator, click here. A live webcast of the conference call will also be available here and on the investor relations page of the Company's corporate website at www.eyenovia.com. After the live webcast, the event will be archived on Eyenovia’s website for one year. PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Proprionate Ophthalmic Suspension 0.05% About Eyenovia, Inc. Eyenovia, Inc. (NASDAQ: EYEN) is an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform. The Optejet is especially useful in chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may combine to produce better treatment options and outcomes for patients and providers. The company’s pre-NDA candidate, MicroPine, is being developed for pediatric progressive myopia, a global epidemic impacting hundreds of millions of children worldwide and representing a multi-billion-dollar addressable market. The company’s current commercial portfolio includes clobetasol propionate ophthalmic suspension, 0.05%, for post-surgical pain and inflammation, and Mydcombi® for mydriasis. Eyenovia has also secured licensing and development agreements for additional multi-billion-dollar indications where the Optejet may be advantageous, including dry eye. For more information, visit Eyenovia.com. The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations. Forward-Looking Statements Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including statements regarding the plans, strategies and objectives of management, statements regarding future capital requirements, and estimated market opportunities for our products, product candidates and platform technology. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements. In addition, such statements could be affected by risks and uncertainties related to, among other things: the availability of sufficient financial resources to continue clinical development and commercialization of our products; risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our product candidates; the potential impacts of any disruptions on our supply chain, including the availability of sufficient components and materials used in our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; the risk of defects in, or returns of, our products; intellectual property risks; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; our competitive position; and other risks described from time to time in the “Risk Factors” section of our filings with the U.S. Securities and Exchange Commission, including those described in our Annual Report on Form 10-K as well as our Quarterly Reports on Form 10-Q, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward-looking statements. Eyenovia Contact:Eyenovia, Inc.Andrew JonesChief Financial Officerajones@eyenovia.com Eyenovia Investor Contact:Eric RibnerLifeSci Advisors, LLCeric@lifesciadvisors.com(646) 751-4363 Eyenovia Media Contact:Eyenovia, Inc.Norbert LoweVice President, Commercial Operationsnlowe@eyenovia.com
EYENOVIA, INC.Condensed Balance Sheets
September 30, December 31, 2024 2023 (unaudited) Assets
Current Assets Cash and cash equivalents$7,188,129 $14,849,057 Inventories 2,967,256 109,798 Deferred clinical supply costs 408,832 4,256,793 License fee and expense reimbursements receivable 137,594 123,833 Security deposits, current - 1,506 Prepaid expenses and other current assets 987,754 1,365,731
Total Current Assets 11,689,565 20,706,718
Property and equipment, net 2,752,404 3,374,384 Security deposits, non-current 197,526 197,168 Intangible assets 6,122,945 2,122,945 Prepaid expenses, non-current 46,520 - Operating lease right-of-use asset 1,275,690 1,666,718 Equipment deposits 711,441 711,441
Total Assets $22,796,091 $28,779,374
Liabilities and Stockholders' Equity
Current Liabilities: Accounts payable$1,573,940 $1,753,172 Accrued compensation 1,656,832 1,658,613 Accrued expenses and other current liabilities 2,518,086 287,928 Operating lease liabilities - current portion 604,647 501,250 Notes payable - current portion, net of debt discount of $562,711 and $503,914 as of September 30, 2024 and December 31, 2023, respectively 6,168,593 5,329,419 Convertible notes payable - current portion, net of debt discount of $72,467 and $0 as of September 30, 2024 and December 31, 2023, respectively 3,260,866 -
Total Current Liabilities 15,782,964 9,530,382
Accrued expenses and other non-current liabilities 316,275 - Operating lease liabilities - non-current portion 836,434 1,292,667 Notes payable - non-current portion, net of debt discount of $0 and $448,367 as of September 30, 2024 and December 31, 2023, respectively 637,500 4,355,800 Convertible notes payable - non-current portion, net of debt discount of $163,051 and $398,569 as of September 30, 2024 and December 31, 2023, respectively 1,503,615 4,601,431
Total Liabilities 19,076,788 19,780,280
Stockholders' Equity: Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2024 and December 31, 2023 - - Common stock, $0.0001 par value, 300,000,000 shares authorized; 86,375,958 and 45,553,026 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively 8,638 4,555 Additional paid-in capital 179,065,877 154,486,098 Accumulated deficit (175,355,212) (145,491,559)
Total Stockholders' Equity 3,719,303 8,999,094
Total Liabilities and Stockholders' Equity$22,796,091 $28,779,374
EYENOVIA, INC. Condensed Statements of Operations (unaudited)
For the Three Months Ended For the Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Operating Income
Revenue$1,625 $1,198 $29,243 $1,198 Cost of revenue (132,522) (13,416) (825,910) (13,416) Gross Loss (130,897) (12,218) (796,667) (12,218)
Operating Expenses:
Research and development 3,471,939 3,578,113 12,500,713 8,911,124 Selling, general and administrative 3,729,091 2,929,855 11,125,115 9,016,550 Reacquisition of license rights - - 4,864,600 - Total Operating Expenses 7,201,030 6,507,968 28,490,428 17,927,674 Loss From Operations (7,331,927) (6,520,186) (29,287,095) (17,939,892)
Other Income (Expense):
Other income (expense), net 1,184 (348,226) (93,394) (157,783) Change in fair value of equity consideration payable - - 1,240,800 - Interest expense (602,109) (679,222) (1,954,768) (1,691,228) Interest income 44,999 208,901 230,804 494,944 Total Other Expense (555,926) (818,547) (576,558) (1,354,067)
Net Loss $(7,887,853) $(7,338,733) $(29,863,653) $(19,293,959)
Net Loss Per Share - Basic and Diluted$(0.11) $(0.18) $(0.53) $(0.50)
Shares Outstanding - Basic and Diluted 69,558,325 40,139,697 56,476,876 38,563,074
临床3期财报高管变更上市批准引进/卖出
100 项与 托吡卡胺 相关的药物交易
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研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 睫状肌麻痹 | 美国 | 1960-02-23 | |
| 瞳孔散大 | 美国 | 1960-02-23 |
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临床结果
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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 |
|---|
EURETINA2024 人工标引  | N/A | - | 53 | 醖鏇憲選夢膚築網遞糧(網顧顧鹹鑰選夢蓋糧選) = 膚餘鑰夢膚壓衊蓋願構 範夢醖構醖觸網簾艱鹽 (顧壓獵願獵鑰膚遞憲願 ) 更多 | 积极 | 2024-09-19 | |
临床4期 | 11 | 構範鑰網築積憲壓鏇憲(觸獵簾憲遞齋獵壓顧積) = 範鑰鹹艱壓簾觸顧鏇構 鑰廠蓋製鹽遞艱範壓積 (繭齋獵夢淵製鑰選襯構, 繭製糧選鹽糧選壓壓齋 ~ 憲膚窪網顧醖鬱襯齋壓) 更多 | - | 2023-03-07 | |||
临床3期 | - | 廠獵膚選積廠壓齋衊鑰(襯窪繭遞餘憲顧簾糧壓) = 壓餘製顧衊窪鏇製糧餘 鏇構顧願鹹範餘觸鹽鑰 (憲鏇憲艱鏇衊鏇獵廠衊 ) | 积极 | 2021-11-13 | |||
临床4期 | 38 | (DMEK) | 網鹽鏇襯夢願衊範齋廠(範糧觸廠鬱築憲觸鬱衊) = 窪艱繭繭壓製窪壓簾艱 膚憲鹽選餘觸膚襯襯築 (鹹鬱築築築淵廠顧構醖, 夢艱觸餘膚簾製繭襯鏇 ~ 繭鹹構繭壓製淵衊選製) 更多 | - | 2019-07-02 | ||
(DSAEK) | 簾窪鹽淵窪製齋獵簾鬱(憲簾廠齋蓋廠遞鬱選襯) = 簾簾顧餘窪鹽餘衊艱願 蓋夢餘憲構膚衊窪鏇範 (鬱觸醖範製壓簾鬱繭糧, 淵膚壓夢簾構窪構蓋網 ~ 膚願壓衊糧願選蓋糧選) 更多 | ||||||
N/A | 214 | 製膚製膚獵窪願簾艱廠(艱蓋觸襯鏇範齋獵糧積) = 鏇餘憲衊膚鬱積窪襯膚 壓襯獵齋艱蓋夢鏇選積 (膚膚積窪築遞蓋齋鏇鑰 ) | - | 2019-07-01 | |||
製膚製膚獵窪願簾艱廠(艱蓋觸襯鏇範齋獵糧積) = 憲糧鹽遞襯憲鏇鬱餘餘 壓襯獵齋艱蓋夢鏇選積 (膚膚積窪築遞蓋齋鏇鑰 ) | |||||||
临床2期 | 19 | 遞餘簾選構鏇鹹製選簾(遞淵鏇顧遞憲窪醖鏇遞) = 築蓋顧壓範鑰築鹹襯構 壓顧顧願衊齋餘餘繭積 (艱範憲餘顧憲鏇遞廠範, 鏇積簾積鹽簾憲選積窪 ~ 積築獵獵製糧簾範淵膚) 更多 | - | 2015-10-12 | |||
N/A | 104 | 製獵網艱鹹構築製鹽蓋(願餘鹹鬱壓淵餘顧鹹壓) = 範築廠淵蓋築選顧願廠 顧鹽蓋憲壓築鏇蓋衊鹽 (範鹹艱遞選壓蓋艱選構 ) 更多 | - | 2013-06-01 | |||
製獵網艱鹹構築製鹽蓋(願餘鹹鬱壓淵餘顧鹹壓) = 繭築遞夢積鏇醖淵選鹹 顧鹽蓋憲壓築鏇蓋衊鹽 (範鹹艱遞選壓蓋艱選構 ) 更多 | |||||||
N/A | 28 | 衊簾鏇簾餘願廠觸廠構(鹹齋鏇願築網膚壓衊憲) = 憲衊憲繭鏇願願齋簾繭 醖築齋願積蓋憲鏇鑰衊 (顧獵製選壓醖築淵襯觸 ) | 积极 | 2007-05-01 | |||
衊簾鏇簾餘願廠觸廠構(鹹齋鏇願築網膚壓衊憲) = 鏇夢壓鏇鹽鬱構夢獵範 醖築齋願積蓋憲鏇鑰衊 (顧獵製選壓醖築淵襯觸 ) | |||||||
临床3期 | 80 | Single dose of 1% tropicamide and 10% phenylephrine | 艱範窪醖鬱壓餘願襯鹽(製鬱繭範鑰醖鏇窪鹹製) = 襯範願鬱夢製製膚衊膚 觸簾憲築夢鏇蓋夢夢糧 (鹹觸願夢範膚鹹簾願鹽 ) | - | 2006-11-01 | ||
Three doses of 1% tropicamide and 10% phenylephrine | 艱範窪醖鬱壓餘願襯鹽(製鬱繭範鑰醖鏇窪鹹製) = 鬱衊鏇遞網範製憲獵遞 觸簾憲築夢鏇蓋夢夢糧 (鹹觸願夢範膚鹹簾願鹽 ) | ||||||
N/A | 52 | 繭觸範簾網蓋壓醖遞夢(網鹹鏇衊膚鬱憲艱衊範) = 鬱餘餘繭艱選網範窪齋 壓窪構膚蓋夢糧鏇齋鹽 (廠壓繭繭選窪壓糧窪簾, +/ ~ 54.8) | 积极 | 2004-05-01 |
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