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]

NCT06213896 / CompletedN/A

Screening And Detecting Eye Diseases With Hybrid Deep Learning Algorithms From Fundus Images And Validation Of Automated Artificial Intelligence Algorithm

Eye health is of great importance for quality of life. Some eye diseases can progress and cause permanent damage up to vision loss if they are not treated early. Therefore, it is of great importance to have regular eye examinations and to detect possible eye diseases before they progress. Healthy people should also undergo eye screening once a year, and those with any complaints regarding eye health should be examined.
With the advancing technology, Artificial Intelligence (AI) has begun to play a significant role in the healthcare sector. Retinal diseases, serious health problems resulting from damage to the back part of the eye's retina, include conditions such as retinopathy, macular degeneration, and glaucoma. Artificial intelligence, with its visual recognition and analysis capabilities, holds great potential in the early diagnosis of retinal diseases.
AI-based diagnosis of retinal diseases typically involves the use of specialized algorithms that analyze retinal images. These algorithms identify abnormal features in the eye, providing doctors with a quick and accurate diagnosis.
EyeCheckup v2.0 will diagnose glaucoma suspicion, severe glaucoma suspicion, age-related macular degeneration diagnosis, RVO diagnosis, diabetic retinopathy diagnosis and stage, presence/absence of DME suspicion and other retinal diseases from fundus images. This study is designed to assess the safety and efficacy of EyeCheckup v2.0.
The study is a single center study to determine the sensitivity and specificity of EyeCheckup to retinal and optic disc diseases. EyeCheckup v2.0 is an automated software device that is designed to analyze ocular fundus digital color photographs taken in frontline primary care settings in order to quickly screen.

开始日期2023-03-01

申办/合作机构

URAL Telekomünikasyon San. Tic. Ltd. Şti.初创企业

100 项与托吡卡胺相关的临床结果

登录后查看更多信息

100 项与托吡卡胺相关的转化医学

登录后查看更多信息

100 项与托吡卡胺相关的专利（医药）

登录后查看更多信息

930

项与托吡卡胺相关的文献（医药）

2024-03-01·Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists)

Short‐term effects of cyclopentolate and tropicamide eye drops on macular choroidal thickness in myopic children

Article

作者: Flitcroft, Daniel Ian ; Loughman, James ; Kobia-Acquah, Emmanuel ; Lingham, Gareth ; Kerin, Eoin

Abstract:

Background:

To investigate the short‐term effects of cyclopentolate and tropicamide eyedrops on choroidal thickness (ChT) in myopic children using placebo or low‐dose atropine eyedrops.

Methods:

The analysis included 242 myopic individuals (7–19 years) enrolled in two randomised placebo‐controlled clinical trials of low‐dose atropine eyedrops. Cycloplegia was induced using either one drop of 1% cyclopentolate (n = 161), two drops of 1% cyclopentolate (n = 32) or two drops of 1% tropicamide (n = 49). ChT measurements were taken using swept‐source optical coherence tomography before and 30 min after administering the cycloplegic eye drops. A subset of 51 participants underwent test–retest measurements prior to cycloplegia.

Results:

Mean changes in subfoveal ChT after two drops of tropicamide and one and two drops of cyclopentolate were −2.5 μm (p = 0.10), −4.3 μm (p < 0.001) and −9.6 μm (p < 0.001), respectively. Subfoveal ChT changes after one and two drops of cyclopentolate were significantly greater than the test–retest changes (test–retest mean change: −3.1 μm; p < 0.05), while the tropicamide group was not significantly different (p = 0.64). Choroidal thinning post‐cyclopentolate was not significantly different between atropine and placebo treatment groups (p > 0.05 for all macular locations). The coefficient of repeatability (CoR) in the tropicamide group (range: 8.2–14.4 μm) was similar to test–retest (range: 7.5–12.2 μm), whereas greater CoR values were observed in the cyclopentolate groups (one drop: range: 10.8–15.3 μm; two drops: range: 12.2–24.6 μm).

Conclusions:

Cyclopentolate eye drops caused dose‐dependent choroidal thinning and increased variation in pre‐ to post‐cycloplegia measurements compared with test–retest variability, whereas tropicamide did not. These findings have practical implications for ChT measurements when cyclopentolate is used, particularly for successive measurements.

2024-02-01·Journal of neurology

Effects of pupil size in video head-impulse tests

Article

作者: Lee, Joo-Hyeong ; Kim, Byung-Jo ; Yoon, Ho-Jin ; Lee, Sun-Uk ; Park, Euyhyun ; Lee, Jeong-Heon ; Kim, Ji-Soo

The results of video head impulse tests (video-HITs) may be confounded by data artifacts of various origins, including pupil size and eyelid obstruction of the pupil. This study aimed to determine the effect of these factors on the results of video-HITs. We simulated ptosis by adopting pharmacological dilatation of the pupil in 21 healthy participants (11 women; age 24-58 years). Each participant underwent video-HITs before and after pupillary dilatation using 0.5% tropicamide. We assessed the changes in the vestibulo-ocular reflex (VOR) gain, corrective saccade amplitude, and frequency of eyelid flicks. After pupillary dilatation, the VOR gain decreased for both right (RAC; 1.12 [Formula: see text] 0.12 vs. 1.01 [Formula: see text] 0.16, p = 0.011) and left anterior canals (LACs; 1.15 [Formula: see text] 0.13 vs. 0.96 [Formula: see text] 0.14, p < 0.001), and right posterior canal (RPC, 1.10 [Formula: see text] 0.13 vs. 0.98 [Formula: see text] 0.09, p = 0.001). The corrective saccade amplitudes also decreased significantly for all four vertical canals. The frequency of eyelid flicks, however, did not change. The changes of VOR gain were positively correlated with the lid excursion in RPC (r = 0.629, p = 0.002) and LPC (r = 0.549, p = 0.010). Our study indicates that eyelid position and pupil size should be considered when interpreting the results of video-HITs, especially for the vertical canals. Pupils should be shrunk in a very well-lit room, and artifacts should be prevented by taping or lifting the eyelids as required during video-HITs.

2024-01-01·American journal of ophthalmology

Tropicamide Versus Cyclopentolate for Cycloplegic Refraction in Pediatric Patients With Brown Irides: A Randomized Clinical Trial

Article

作者: Al-Omari, Rami ; Abu Serhan, Hashem ; Al-Awadhi, Abdullah ; Abu-Hassan, Diala Walid ; Al-Thawabieh, Wejdan ; Abuawwad, Mohammad T

PURPOSE:

To compare the final cycloplegic refraction of tropicamide 1% and cyclopentolate 1% in children 3-16 years of age with brown irides.

DESIGN:

Randomized, controlled, multicenter prospective clinical trial.

METHODS:

Included patients were randomized to either cyclopentolate 1% or tropicamide 1% in the first visit with autorefraction measurements. Each subject underwent a second cycloplegic refraction using the other agent on a separate visit with a minimum of 1-week interval and a maximum of 12 weeks. We measured the change in SE (ΔSE) for each eye by deducting the SE before cycloplegia from the SE after cycloplegia.

RESULTS:

A total of 185 eyes from 94 children aged 3-16 years (average= 8.79 ±3.11 years) were included. The average SE of both eyes before cycloplegia was -0.082 ± 4.8 diopters. The SE after instillation of cyclopentolate and tropicamide in both eyes was 1.07±5.2 and 0.96±5.1, respectively (P value < .001). The average ΔSE after cycloplegia was 1.15±1.2 for cyclopentolate and 1.04±1.2 for tropicamide (P value < .001). The difference between ΔSE of cyclopentolate and tropicamide was found statistically significant at 0.11±1.2 (P < .001), although clinically insignificant. The ΔSE between the 2 drops before and after cycloplegia in both eyes for all refractive error groups was clinically insignificant. The greatest effect of cyclopentolate and tropicamide was in hyperopic eyes with ΔSE of 1.54±1.4 and 1.39±1.4, respectively.

CONCLUSIONS:

Tropicamide might be an effective and safe replacement for cyclopentolate in the refracting nonstrabismic pediatric population 3-16 years of age regardless of their refractive error status.

项与托吡卡胺相关的新闻（医药）

2024-06-28

·GlobeNewswire-Health Care

Eyenovia Announces Pricing of $5M Registered Direct Offering

NEW YORK, June 28, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (“Eyenovia” or the “Company”) (NASDAQ: EYEN), a commercial-stage ophthalmic company, announced today that it has entered into a securities purchase agreement with an institutional investor and its current largest stockholder, providing for the purchase and sale of 7,575,757 shares of common stock, and warrants to purchase up to 7,575,757 shares of common stock (the "Offering"). The combined offering price for each share of common stock and accompanying warrant is $0.66. The warrants will have an exercise price of $0.69 per share, are exercisable six months from issuance, and will expire 5.5 years from the date of issuance. The closing of the Offering is expected to occur on or about July 1, 2024, subject to the satisfaction of customary closing conditions. All of the securities in the Offering are being sold by Eyenovia. Chardan is acting as the lead-placement agent for the Offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, is also acting as a co-placement agent for the Offering. The gross proceeds to Eyenovia from this Offering are expected to be approximately $5 million, before deducting the placement agents’ fees and other offering expenses payable by Eyenovia. Eyenovia intends to use the net proceeds from this Offering to fund commercialization activities for Mydcombi and clobetasol propionate, complete the CHAPERONE pediatric myopia clinical study, and for working capital and general corporate purposes, which may include the repayment of a portion of existing indebtedness. The securities described above are being offered by Eyenovia pursuant to its previously filed shelf registration statement on Form S-3, which was declared effective by the Securities and Exchange Commission (the “SEC”) on December 23, 2021. The Offering may be made only by means of a prospectus supplement and accompanying prospectus. A prospectus supplement relating to the Offering will be filed with the SEC and once filed, will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement and the accompanying base prospectus relating to the Offering may also be obtained by contacting Chardan Capital Markets, LLC, Attn: Capital Markets, One Pennsylvania Plaza, Suite 4800, New York, New York 10119, by email at prospectus@chardan.com. This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. About Eyenovia, Inc. Eyenovia, Inc. is an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis, Clobetasol Propionate Ophthalmic Suspension, 0.05% for postsurgical inflammation and pain, and developing the Optejet® device for use both in connection with its own drug-device therapeutic product for pediatric progressive myopia as well as out-licensing for additional indications. For more information, please 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 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 estimated market opportunities for our product candidates and platform technology, the timing for sales growth of our approved products, and the outcome of the process to explore strategic alternatives to maximize shareholder value. 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 due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, those relating to the Offering, the closing of the Offering, the amount and anticipated use of proceeds from the Offering, 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 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; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products and product candidates; and our competitive position. 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.John GandolfoChief Financial Officerjgandolfo@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

2024-05-27

·信狐药迅

两个优先1类：复星MEK1/2抑制剂复迈替尼两适应症、加科思KRAS 抑制剂格来雷塞提交上市申请|新受理（5.20-5.26）

本周药品注册受理数据，分门别类呈现，一目了然。(5.20-5.26）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号复迈替尼片上海复星医药产业发展有限公司1CXHS2400047复迈替尼片上海复星医药产业发展有限公司1CXHS2400046枸橼酸格来雷塞片北京加科思新药研发有限公司1CXHS2400044水合氯醛口服液成都亚中生物制药有限责任公司2.2CXHS2400045替妥尤单抗注射液信达生物制药(苏州)有限公司2.1CXSS2400050新药临床申请药品名称企业注册分类受理号YZG-331片中国医学科学院药物研究所1CXHL2400519ENN0403胶囊轶诺(浙江)药业有限公司1CXHL2400524DG01片苏州德亘生物医药有限公司1CXHL2400523DG01片苏州德亘生物医药有限公司1CXHL2400522BG-68501片百济神州(苏州)生物科技有限公司1CXHL2400521BG-68501片百济神州(苏州)生物科技有限公司1CXHL2400520HLX208片上海复宏汉霖生物技术股份有限公司1CXHL2400518注射用WE011上海宝龙药业股份有限公司1CXHL2400517SAL0120片深圳信立泰药业股份有限公司1CXHL2400513SAL0120片深圳信立泰药业股份有限公司1CXHL2400512XJN010鼻喷雾剂广州新济药业科技有限公司2.2CXHL2400526HKG-319国药瑞福莱药业有限公司2.2CXHL2400515HKG-319国药瑞福莱药业有限公司2.2CXHL2400514SMF-215江西施美药业股份有限公司2.3CXHL2400516青蒿琥酯片桂林南药股份有限公司2.4CXHL2400527米诺地尔泡沫剂(女用)山西振东安欣生物制药有限公司3CYHL2400101米诺地尔泡沫剂(男用)山西振东安欣生物制药有限公司3CYHL2400100甘露醇山梨醇注射液内蒙古白医制药股份有限公司3CYHL2400099HR19024注射液上海恒瑞医药有限公司2.2;2.4CXHL2400525重组破伤风疫苗(大肠埃希菌)远大赛威信生命科学(南京)有限公司1.2CXSL2400340LY01620南京吉迈生物技术有限公司1CXSL2400349注射用ZGGS18苏州泽璟生物制药股份有限公司1CXSL2400348注射用ZG005苏州泽璟生物制药股份有限公司1CXSL2400347RC148注射液荣昌生物制药(烟台)股份有限公司1CXSL2400346注射用RC118荣昌生物制药(烟台)股份有限公司1CXSL2400345JH013注射液百泰生物药业有限公司1CXSL2400342SHR-3821注射液苏州盛迪亚生物医药有限公司1CXSL2400341注射用HS-20124常州恒邦药业有限公司1CXSL2400344GenSci098注射液长春金赛药业有限责任公司1CXSL2400343SHR-7787注射液上海恒瑞医药有限公司1CXSL2400336Obexelimab注射液上海泽纳仕生物科技有限公司1CXSL2400339DCTY1102注射液北京鼎成肽源生物技术有限公司1CXSL2400338SHR-7787注射液上海恒瑞医药有限公司1CXSL2400337IBI354信达生物制药(苏州)有限公司1CXSL2400335SHR-1819注射液广东恒瑞医药有限公司1CXSL2400334mp105深圳瀛晟生物医药有限公司1CXSL2400332SYS6020注射液石药集团中奇制药技术(石家庄)有限公司1CXSL2400333仿制药申请药品名称企业注册分类受理号盐酸甲氧氯普胺注射液北京民康百草医药科技有限公司3CYHS2401573乙酰半胱氨酸注射液湖北津药药业股份有限公司3CYHS2401572盐酸倍他司汀片上海理想制药有限公司3CYHS2401560吸入用盐酸丙卡特罗溶液成都天之翼尚品医药科技有限公司3CYHS2401557复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液山东齐都药业有限公司3CYHS2401556盐酸布比卡因注射液广州艾格生物科技有限公司3CYHS2401555复方氨基酸(15AA-II)/葡萄糖(10%)电解质注射液山东齐都药业有限公司3CYHS2401554盐酸布比卡因注射液广州艾格生物科技有限公司3CYHS2401553盐酸布比卡因注射液北京民康百草医药科技有限公司3CYHS2401571盐酸布比卡因注射液北京民康百草医药科技有限公司3CYHS2401570尼麦角林片海南通用三洋药业有限公司3CYHS2401569尼麦角林片海南通用三洋药业有限公司3CYHS2401567盐酸溴己新注射液黑龙江澳利达奈德制药有限公司3CYHS2401551氨溴特罗口服溶液山东新华制药股份有限公司3CYHS2401549吲哚布芬片河北龙海药业有限公司3CYHS2401547二硫化硒洗剂安徽省先锋制药有限公司3CYHS2401529二羟丙茶碱注射液广州合和医药有限公司3CYHS2401528洛索洛芬钠细粒剂浙江百代医药科技有限公司3CYHS2401527盐酸丙美卡因滴眼液浙江莎普爱思药业股份有限公司3CYHS2401525平衡盐冲洗液西安京西双鹤药业有限公司3CYHS2401523平衡盐冲洗液西安京西双鹤药业有限公司3CYHS2401522盐酸纳美芬注射液山东如至生物医药科技有限公司3CYHS2401539法莫替丁注射液北京格林意锐医药科技有限责任公司3CYHS2401538法莫替丁注射液北京格林意锐医药科技有限责任公司3CYHS2401537氨溴特罗口服溶液广东南国药业有限公司3CYHS2401536西咪替丁注射液南京斯泰尔医药科技有限公司3CYHS2401535盐酸异丙肾上腺素注射液湖南华纳大药厂股份有限公司3CYHS2401534盐酸异丙肾上腺素注射液湖南华纳大药厂股份有限公司3CYHS2401533倍他米松磷酸钠注射液成都瑞尔医药科技有限公司3CYHS2401520左乙拉西坦缓释片佛山德芮可制药有限公司3CYHS2401519左乙拉西坦缓释片佛山德芮可制药有限公司3CYHS2401517腺苷钴胺胶囊海南全星制药有限公司3CYHS2401521吗啉硝唑氯化钠注射液辽宁民康制药有限公司4CYHS2401574甲巯咪唑片江苏德源药业股份有限公司4CYHS2401563注射用盐酸吉西他滨江苏诚康药业有限公司4CYHS2401562复方甘草酸苷片北京远方通达医药技术有限公司4CYHS2401561枸橼酸莫沙必利片上海理想制药有限公司4CYHS2401559阿莫西林克拉维酸钾片浙江巨泰药业有限公司4CYHS2401558达格列净二甲双胍缓释片(I)河南立诺制药有限公司4CYHS2401568达格列净二甲双胍缓释片(IV)河南立诺制药有限公司4CYHS2401566注射用头孢唑肟钠武汉恒泰医药科技有限公司4CYHS2401565注射用头孢唑肟钠武汉恒泰医药科技有限公司4CYHS2401564左炔诺孕酮片武汉九珑人福药业有限责任公司4CYHS2401548拉莫三嗪分散片仁合益康集团有限公司4CYHS2401546头孢托仑匹酯颗粒北京诚济制药股份有限公司4CYHS2401545巴瑞替尼片江苏万邦生化医药集团有限责任公司4CYHS2401544巴瑞替尼片江苏万邦生化医药集团有限责任公司4CYHS2401543左氧氟沙星滴眼液海南斯达制药有限公司4CYHS2401542瑞舒伐他汀依折麦布片(Ⅱ)浙江诺得药业有限公司4CYHS2401541瑞舒伐他汀依折麦布片(I)浙江诺得药业有限公司4CYHS2401540氧山东宏运达赭山气体有限公司4CYHS2401552硫酸氨基葡萄糖胶囊浙江亚克药业有限公司4CYHS2401550盐酸羟考酮缓释片江苏恩华药业股份有限公司4CYHS2401532盐酸尼卡地平注射液浙江赛默制药有限公司4CYHS2401531艾考糊精腹膜透析液芜湖道润药业有限责任公司4CYHS2401530阿司匹林肠溶片江苏济茗医药有限公司4CYHS2401526替米沙坦氨氯地平片天津恒翊药业有限公司4CYHS2401524普拉洛芬滴眼液浙江视方极医药科技有限公司4CYHS2401518帕拉米韦氯化钠注射液仁合益康集团有限公司4CYHS2401516帕拉米韦氯化钠注射液仁合益康集团有限公司4CYHS2401515硫酸镁钠钾口服用浓溶液江苏广承药业有限公司4CYHS2401514非布司他片湖北亨迪药业股份有限公司4CYHS2401513非布司他片湖北亨迪药业股份有限公司4CYHS2401512硫酸氨基葡萄糖胶囊北京百美特生物制药有限公司4CYHS2401511达可替尼片山东朗诺制药有限公司4CYHS2401510达可替尼片山东朗诺制药有限公司4CYHS2401509复方托吡卡胺滴眼液苏州欧康维视生物科技有限公司4CYHS2401508进口申请药品名称企业注册分类受理号环磷酰胺片Baxter Oncology GmbH5.1JXHS2400036艾沙妥昔单抗注射液Sanofi Winthrop Industrie2.2JXSS2400044艾沙妥昔单抗注射液Sanofi Winthrop Industrie2.2JXSS2400043VSA001注射液Arrowhead Pharmaceuticals, Inc.1JXHL2400116Astegolimab注射液F. Hoffmann-La Roche Ltd1JXSL2400103Englumafusp alfa注射液F.Hoffmann-La Roche Ltd.1JXSL2400098ABBV-382注射液AbbVie Inc.1JXSL2400097Epcoritamab注射用浓溶液AbbVie Inc.2.2JXSL2400102Epcoritamab注射用浓溶液AbbVie Inc.2.2JXSL2400101Epcoritamab注射液AbbVie Inc.2.2JXSL2400100Epcoritamab注射液AbbVie Inc.2.2JXSL2400099中药相关申请药品名称企业注册分类受理号CRA杏林中医药科技(广州)有限公司1.2CXZL2400031CRA片杏林中医药科技(广州)有限公司1.2CXZL2400030不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市疫苗临床申请优先审批

2024-05-15

·GlobeNewswire-Health Care

Eyenovia Reports First Quarter 2024 Financial Results and Provides Updates on its Myopia Phase III Program and its Two FDA Approved Commercial Products, Mydcombi and Clobetasol

Remains on track towards accelerating development of its late-stage product candidate in the multi-billion-dollar pediatric progressive myopia market, MicroPine Preparing for a 3Q 2024 launch of the first new ophthalmic steroid in 15 years, clobetasol propionate ophthalmic suspension 0.05%, for the treatment of inflammation and pain following ocular surgery Company to host conference call and webcast today, May 15th, at 4:30 pm ET NEW YORK, May 15, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced its financial and operating results for the first quarter ended March 31, 2024. First Quarter 2024 and Recent Business Developments Announced updated plans to accelerate development of its late-stage product candidate for pediatric progressive myopia, MicroPine. These plans include a protocol amendment to allow for a Data Monitoring Committee to review the Phase 3 CHAPERONE study data early in the fourth quarter. External sources have valued the pediatric progressive myopia market at over $3.0 billion annually in the U.S. and China.Announced FDA approval of clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain following ocular surgery. Eyenovia is planning a launch of this product in the third quarter of 2024. Clobetasol has a desirable clinical profile as compared to other topical ocular steroids with twice-a-day dosing, a high level of efficacy and with adverse events occurring in fewer than 2% of patients.Reported training and shipping product to 50 new Mydcombi-using offices by its initial five Key Account Managers since sales promotion started in April 2024. Additionally, formulary agreements with Vision Source and the University of California have been executed.Reduced the Company’s anticipated cash-based expenses by approximately $0.8 million per quarter from first quarter 2024 actual levels. Michael Rowe, Chief Executive Officer, commented, “During the first quarter of 2024, we took tangible steps to increase the inherent value of our company, which currently includes our novel Optejet technology, two FDA-approved products, and a third in late Phase 3 development. With highly differentiated and desirable products such as Mydcombi for mydriasis and clobetasol for post-surgical pain and inflammation, we look forward to meaningful sales growth over the next 18 months that we anticipate will lead us towards profitability. And our crown jewel, MicroPine for progressive myopia, if approved, would add significant value to the company by addressing a key unmet medical need of the approximately five million at-risk children in the U.S. alone.” “We believe the progress that we continue to make toward optimizing our platform technology has laid a strong foundation towards transforming Eyenovia into a leader in the development and commercialization of topical ophthalmic products and medications. We are committed to demonstrating the value of our existing and near-term products as well as future product candidates in ophthalmic markets with high unmet needs.” “At the same time, we completed the build-out of our manufacturing capabilities, with FDA approval of our Redwood City location in addition to our Reno facility and Coastline International as our contract manufacturer. With all three facilities online, we are currently producing commercial supply of Mydcombi while at the same time supporting both current and future development partnerships as well as our transition from the Gen-1 to Gen-2 Optejet dispenser. To that end, we recently requested a meeting with the FDA to discuss our validation of the Gen-2 dispenser, which we anticipate will occur this summer,” Mr. Rowe concluded. First Quarter 2024 Financial Review For the first quarter of 2024, net loss was approximately $10.9 million, or $0.23 per share, as compared to a net loss of $5.7 million, or $0.15 per share, for the first quarter of 2023. The first quarter 2024 net loss includes $2.5 million of expense, or $0.05 loss per share, associated with the reacquisition of the license rights from Bausch for MicroPine and the write off of related clinical trial inventory. Research and development expenses totaled approximately $4.4 million for the first quarter of 2024, compared to $2.5 million for the first quarter of 2023, an increase of approximately 75.7%. For the first quarter of 2024, general and administrative expenses were approximately $3.8 million, compared to $2.9 million for the first quarter of 2023, an increase of approximately 30.6%. Total operating expenses for the first quarter of 2024 were approximately $10.3 million, including the previously referenced $2.5 million of expenses associated with the Bausch transaction, compared to approximately $5.5 million for the first quarter of 2023. This represents an increase of approximately 88.1%. The first quarter 2024 operating expense figure includes approximately $1.5 million of non-cash expenses. As of March 31, 2024, the Company’s unrestricted cash and cash equivalents were approximately $8.0 million, not including $2.2 million in additional capital the Company raised in April 2024. Conference Call and Webcast The conference call is scheduled to begin at 4:30 pm ET today, May 15th. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470 (international), and reference conference ID 13746269. 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 a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi (tropicamide+phenylephrine ophthalmic spray) for mydriasis, as well as clobetasol propionate ophthalmic nanosuspension 0.05% to reduce pain and inflammation following ocular surgery, which was approved by the FDA on March 4, 2024. Eyenovia is also advancing late-stage development of medications in the Optejet device for presbyopia (Apersure) and myopia progression (MicroPine, partnered with Arctic Vision in China and South Korea). 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 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: 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.John GandolfoChief Financial Officerjgandolfo@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 Sheet March 31, December 31, 2024 2023 (unaudited) Assets Current Assets Cash and cash equivalents $7,976,106 $14,849,057 Inventories 3,513,860 109,798 Deferred clinical supply costs 846,301 4,256,793 License fee and expense reimbursements receivable 88,045 123,833 Security deposits, current 1,506 1,506 Prepaid expenses and other current assets 2,025,267 1,365,731 Total Current Assets 14,451,085 20,706,718 Property and equipment, net 3,155,710 3,374,384 Security deposits, non-current 197,168 197,168 Intangible assets 6,122,945 2,122,945 Operating lease right-of-use asset 1,538,814 1,666,718 Equipment deposits 711,441 711,441 Total Assets $26,177,163 $28,779,374 Liabilities and Stockholders' Equity Current Liabilities: Accounts payable $2,145,272 $1,753,172 Accrued compensation 828,286 1,658,613 Accrued expenses and other current liabilities 4,751,755 287,928 Operating lease liabilities - current portion 579,585 501,250 Notes payable - current portion, net of debt discount of $621,712 and $503,914 as of March 31, 2024 and December 31, 2023, respectively 8,155,025 5,329,419 Total Current Liabilities 16,459,923 9,530,382 Operating lease liabilities - non-current portion 1,140,231 1,292,667 Notes payable - non-current portion, net of debt discount of $200,711 and $448,367 as of March 31, 2024 and December 31, 2023, respectively 2,103,456 4,355,800 Convertible notes payable - net of debt discount of $344,219 and $398,569 as of March 31, 2024 and December 31, 2023, respectively 4,655,781 4,601,431 Total Liabilities 24,359,391 19,780,280 Stockholders' Equity: Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023 Common stock, $0.0001 par value, 90,000,000 shares authorized; 47,386,349 and 45,553,026 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively 4,738 4,555 Additional paid-in capital 158,226,694 154,486,098 Accumulated deficit (156,413,660) (145,491,559) Total Stockholders' Equity 1,817,772 8,999,094 Total Liabilities and Stockholders' Equity $26,177,163 $28,779,374 EYENOVIA, INC. Condensed Statements of Operations(unaudited) For the Three Months Ended March 31, 2024 2023Operating Income Revenue $4,993 $- Cost of revenue (4,993) - Gross Profit - - Operating Expenses: Research and development 4,431,601 2,521,950 General and administrative 3,835,223 2,936,886 Reacquisition of license rights 2,000,000 - Total Operating Expenses 10,266,824 5,458,836 Loss From Operations (10,266,824) (5,458,836) Other Income (Expense): Other (expense) income, net (97,558) 70,993 Interest expense (678,658) (454,003)Interest income 120,939 102,480 Total Other Expense (655,277) (280,530) Net Loss $(10,922,101) $(5,739,366) Net Loss Per Share - Basic and Diluted $(0.23) $(0.15) Shares Outstanding - Basic and Diluted 46,606,790 37,410,587

临床3期上市批准财报

100 项与托吡卡胺相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D00397	托吡卡胺	S01FA06	DB00809

研发状态

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
睫状肌麻痹	美国	Alcon Laboratories, Inc.	1960-02-23
瞳孔散大	美国	Alcon Laboratories, Inc.	1960-02-23

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05238233 (CTgov)	临床4期	瞳孔不等	11	Reichert phoropter+Tropicamide+1% Pilocarpine	衊選遞遞衊蓋鏇齋壓選(繭鑰窪觸壓艱憲夢鬱艱) = 製築網憲鬱鑰遞願遞顧膚醖醖鬱繭廠積壓鹹衊 (獵衊鹹繭積鏇糧觸襯餘, 築鬱鑰構繭壓遞構膚餘 ~ 艱夢積鏇範膚製廠鏇鏇) 更多	-	2023-03-07
PO136 (AAO2021)	临床3期	-	-	Intracameral fixed combination tropicamide 0.02%, phenylephrine 0.31%, lidocaine 1%	構願積願構願鏇遞蓋鏇(遞選糧夢鹹艱繭遞壓製) = 簾繭遞襯構鏇齋簾鹹鑰壓願獵顧憲夢遞選淵顧 (壓襯鏇鏇範夢醖糧醖淵 )	积极	2021-11-13
NCT02373137 (CTgov)	临床4期	角膜疾病 \| 角膜移植排斥反应	38	DMEK+Tropicamide+phenylephrine+prednisolone+Ofloxacin (DMEK)	糧夢窪憲製顧壓膚範淵(鬱鹹餘簾積願廠膚壓構) = 鹽憲築鬱製鹹鏇壓膚簾繭夢鹹積餘壓窪夢憲壓 (淵齋鑰製鏇窪觸襯憲醖, 艱觸觸襯夢選襯醖範夢 ~ 願選鏇蓋構鹹築鹹鬱廠) 更多	-	2019-07-02
				DSAEK+Tropicamide+phenylephrine+prednisolone+Ofloxacin (DSAEK)	鑰遞顧遞膚窪壓遞窪壓(構蓋築構餘夢醖蓋選構) = 鬱選獵壓遞獵簾範觸遞鏇構網願糧蓋構鹽廠餘 (鹹遞鑰選夢憲遞憲遞築, 醖遞製鹽簾艱襯遞憲簾 ~ 窪獵廠醖鹽窪壓齋襯廠) 更多
NCT00761137 (CTgov)	临床2期	继发性帕金森病 \| 流涎	19	1 mg tropicamide	鏇鏇鏇簾構鏇窪膚選糧(簾襯膚遞衊憲鹽廠夢鏇) = 築蓋餘憲艱窪壓鹹襯淵襯齋鏇齋願繭壓廠齋窪 (簾窪膚鑰選遞網艱窪蓋, 夢齋觸願蓋觸鹹鹹鹹膚 ~ 壓願獵衊醖觸鬱鬱積蓋) 更多	-	2015-10-12
ARVO2013	N/A	高血压	104	Tropicamide 1%	衊憲窪鹽窪壓積憲鬱壓(願範憲糧壓糧鏇鏇願選) = 窪壓網憲膚膚簾衊範願鑰淵壓醖蓋願艱艱鏇築 (夢鹽鹽遞鏇餘網獵鹽繭 ) 更多	-	2013-06-01
				Tropicamide 1% & Phenylephrine 2.5%	衊憲窪鹽窪壓積憲鬱壓(願範憲糧壓糧鏇鏇願選) = 壓艱願網憲獵膚鏇衊繭鑰淵壓醖蓋願艱艱鏇築 (夢鹽鹽遞鏇餘網獵鹽繭 ) 更多
NCT00761137 (Pubmed \| J Neurol Sci)	临床2期	帕金森病	19	Tropicamide 0.3mg	衊鏇廠範範壓糧範鬱艱(鏇餘願艱願製憲築願範) = 築鏇鏇鬱壓鏇膚遞衊憲製蓋餘衊構蓋築膚艱製 (襯鬱鏇製壓選蓋糧衊鹹 )	积极	2011-11-15
				Tropicamide 1mg	衊鏇廠範範壓糧範鬱艱(鏇餘願艱願製憲築願範) = 範簾鹹艱製糧淵鏇鹹淵製蓋餘衊構蓋築膚艱製 (襯鬱鏇製壓選蓋糧衊鹹 )
ARVO2007	N/A	瞳孔散大	28	Tropicamide 1%	淵鹽鏇鑰鹹鏇蓋簾顧壓(願鬱網觸鹽構觸憲衊齋) = 艱積齋製壓製蓋選簾襯衊憲築製鹹憲網鏇廠憲 (製鏇觸簾積艱積糧艱鬱 )	积极	2007-05-01
				Phenylephrine 2.5%	淵鹽鏇鑰鹹鏇蓋簾顧壓(願鬱網觸鹽構觸憲衊齋) = 簾壓夢積蓋製壓製醖鏇衊憲築製鹹憲網鏇廠憲 (製鏇觸簾積艱積糧艱鬱 )
NCT00120432 (Pubmed)	临床3期	眼部疾病	80	Single dose of 1% tropicamide and 10% phenylephrine	膚顧鹹製獵觸衊鏇構築(鏇獵獵範網鏇觸淵觸鹹) = 夢淵選築襯醖餘膚鑰醖鹹膚鬱醖餘鬱鹹齋憲選 (膚鬱餘壓壓艱憲顧顧夢 )	-	2006-11-01
				Three doses of 1% tropicamide and 10% phenylephrine	膚顧鹹製獵觸衊鏇構築(鏇獵獵範網鏇觸淵觸鹹) = 廠簾憲鏇築鏇餘齋構鑰鹹膚鬱醖餘鬱鹹齋憲選 (膚鬱餘壓壓艱憲顧顧夢 )
ARVO2004	N/A	角膜变薄	52	G.Tropicamide 1%	範鑰網襯窪壓壓簾艱壓(鑰遞廠艱構積壓鹹淵鹽) = 鏇膚夢夢齋廠製襯淵鹽簾餘夢蓋積夢鹽夢觸醖 (蓋壓憲糧鬱願積願鏇鬱, +/ ~ 54.8)	积极	2004-05-01
P114 (AAO2000)	N/A	-	-	Tropicamide 1%	膚範鏇鏇醖網艱鬱膚淵(鹽築構餘簾簾膚構憲獵) = 衊網夢鹽膚壓鹹鏇鹽蓋簾願淵鬱廠遞蓋廠範憲 (築繭願範簾齋餘夢遞網, 0.78)	-	2000-10-22
				Cyclopentolate 1%	膚範鏇鏇醖網艱鬱膚淵(鹽築構餘簾簾膚構憲獵) = 膚積積顧艱憲齋積簾淵簾願淵鬱廠遞蓋廠範憲 (築繭願範簾齋餘夢遞網, 0.78)