Eyenovia Stock Tumbles on Termination of Phase III Myopia Study

Zacks11-18

Eyenovia, Inc. EYEN announced the decision to terminate a phase III study evaluating its investigational drug-device product, MicroPine, as a potential treatment for pediatric progressive myopia. ...

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MicroPine is EYEN’s proprietary drug-device combination of low-dose atropine administered using the company’s Optejet dispensing platform.The decision was taken after an independent Data Review Committee  determined that the phase III CHAPERONEstudy of MicroPine was unlikely to meet its primary endpoint of less than 0.5 diopter progression in visual acuity over three years.The DRC evaluated safety and efficacy data from 252 patients and found no significant difference in myopia progression between the two treatment groups  and placebo. However, all doses of the candidate and the placebo were well-tolerated in the CHAPERONEstudy, with only mild and infrequent adverse events. The complete study data is yet to be provided to Eyenovia.Based on this DRC feedback, Eyenovia has decided to terminate th","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU2087621335.USD":"ALLSPRING GLOBAL FACTOR ENHANCED EQUITY \"A\" (USD) ACC","III":"信息服务","LU1066053197.SGD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM3\" (SGDHDG) INC","ALLO":"Allogene Therapeutics Inc.","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","IE0002270589.USD":"LEGG MASON CLEARBRIDGE VALUE \"A\" (USD) INC","BK4581":"高盛持仓","LU2468319806.SGD":"MANULIFE GF HEALTHCARE \"AA\" (SGDHDG) ACC","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","BK4583":"猴痘概念","BK4532":"文艺复兴科技持仓","LU1894683348.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) INC","BK4592":"伊斯兰概念","LU1571399168.USD":"ALLSPRING GLOBAL LONG/SHORT EQUITY \"IP\" (USD) ACC","IE00BLSP4452.SGD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis SGD-H Plus","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","LU0306807586.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" (USD) INC QF","BK4585":"ETF&股票定投概念","BK4139":"生物科技","LU0234570918.USD":"高盛全球核心股票组合Acc Close","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H","BK4533":"AQR资本管理(全球第二大对冲基金)","IE00B19Z3581.USD":"Legg Mason ClearBridge - Value A Acc USD","BK4566":"资本集团","EYEN":"Eyenovia Inc.","BK4007":"制药","BK4578":"CAR-T","LU1023059063.AUD":"BGF WORLD HEALTHSCIENCE \"A2\" (AUDHDG) ACC","LU0289739699.SGD":"AB INTERNATIONAL HEALTH CARE PORTFOLIO \"A\" (SGD) ACC","IE00B19Z3B42.SGD":"Legg Mason ClearBridge - Value A Acc SGD","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","BK4568":"美国抗疫概念","BK4550":"红杉资本持仓","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","LU0321505439.SGD":"Schroder ISF Global Dividend Maximiser A Acc SGD","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","LU0234572021.USD":"高盛美国核心股票组合Acc","SG9999002232.USD":"Allianz Global High Payout USD","LU0985481810.HKD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (HKD) INC M","BK4134":"信息科技咨询与其它服务","SG9999002224.SGD":"Allianz Global High Payout SGD","LU1894683264.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) ACC","LU0058720904.USD":"联博国际健康护理基金A","LU0225771236.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" (USD) INC MF","PFE":"辉瑞","BK4505":"高瓴资本持仓","GILD":"吉利德科学","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC"},"translate_title":"Eyenovia股价因III期近视研究终止而暴跌","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ALLO":1,"III":1,"PFE":1,"GILD":1,"EYEN":0.9},"content_text":"Eyenovia, Inc. EYEN announced the decision to terminate a phase III study evaluating its investigational drug-device product, MicroPine, as a potential treatment for pediatric progressive myopia. MicroPine is EYEN’s proprietary drug-device combination of low-dose atropine administered using the company’s Optejet dispensing platform.\nThe decision was taken after an independent Data Review Committee (DRC) determined that the phase III CHAPERONE study of MicroPine was unlikely to meet its primary endpoint of less than 0.5 diopter progression in visual acuity over three years.\nThe DRC evaluated safety and efficacy data from 252 patients and found no significant difference in myopia progression between the two treatment groups (0.01% and 0.1% atropine ophthalmic metered spray) and placebo. However, all doses of the candidate and the placebo were well-tolerated in the CHAPERONE study, with only mild and infrequent adverse events. The complete study data is yet to be provided to Eyenovia.\nBased on this DRC feedback, Eyenovia has decided to terminate the phase III CHAPERONE study of MicroPine for the myopia indication. The company is currently gearing up for a thorough review of the study data to evaluate next steps.\nThe stock plunged 70% on Friday following the news. Year to date, shares of EYEN have plunged 95.1% compared with the industry’s 10.5% decline.\nImage Source: Zacks Investment Research\nThe company further reported that it is also exploring ways to maximize stakeholder value, cut costs and assess strategic options, which may include a business combination, reverse merger, asset sales, or a combination of these. Additional details will be shared after the evaluation is complete.\nEYEN’s Marketed Portfolio of Drugs\nThe company currently has two FDA-approved products, Mydcombi and clobetasol propionate, which are indicated for in-office pupil dilation and post-ocular inflammation and pain, respectively. Both drugs are yet to gain traction in the market.\nMydcombi received FDA approval in May 2023 for inducing mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is desired. The drug was launched in the U.S. market in August 2023. Clobetasol propionate, on the other hand, was only approved by the FDA in March 2024 and subsequently launched in the United States during the third quarter of 2024.\nApart from MicroPine, Eyenovia’s clinical-stage pipeline comprises a few other candidates that are currently undergoing mid-stage development for various dry eye indications.\n\nEyenovia, Inc. Price and Consensus\n\nEyenovia, Inc. price-consensus-chart | Eyenovia, Inc. Quote\n\nEYEN’s Zacks Rank and Other Stocks to Consider\nEyenovia currently carries a Zacks Rank #2 (Buy).  \nSome other top-ranked pharma stocks are Allogene Therapeutics ALLO, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nAllogene Therapeutics’ loss estimates per share have narrowed from $1.40 to $1.35 for 2024 over the past 60 days, while that for 2025 has narrowed from $1.46 to $1.34. ALLO shares have lost 29.3% year to date.\nAllogene Therapeutics’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 9.42%.\nPfizer’s earnings estimates have risen from $2.62 to $2.88 per share for 2024 over the past 60 days, while that for 2025 has increased from $2.85 to $2.92. PFE shares have lost 13.9% year to date.\nPfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.\nGilead Sciences’ earnings estimates have risen from $3.79 to $4.28 per share for 2024 over the past 60 days, while that for 2025 has increased from $7.24 to $7.40. GILD shares have risen 9.1% year to date.\nGilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nPfizer Inc. (PFE) : Free Stock Analysis Report\nGilead Sciences, Inc. (GILD) : Free Stock Analysis Report\nEyenovia, Inc. (EYEN) : Free Stock Analysis Report\nAllogene Therapeutics, Inc. (ALLO) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-2","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.4","shortVersion":"4.29.4","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2484260388"}