FDA accepts Opus Genetics sNDA for phentolamine ophthalmic solution 0.75% to treat presbyopia

Reuters02-25 19:59

FDA accepts <a href="https://laohu8.com/S/IRD">Opus Genetics</a> sNDA for phentolamine ophthalmic solution 0.75% to treat presbyopia

Opus Genetics Inc. said the U.S. Food and Drug Administration has accepted for review its supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia. The agency set a PDUFA goal date of Oct. 17, 2026. The product, marketed as Ryzumvi, is currently approved in the U.S. for reversal of pharmacologically induced mydriasis, and the filing seeks to expand its indication; Viatris holds exclusive U.S. commercialization rights under a licensing agreement.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Opus Genetics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202602250659PRIMZONEFULLFEED9660292) on February 25, 2026, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2614899120?lang=en_US&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2026-02-25 19:59","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2614899120","market":"fut","top_or_hot":-1,"title":"FDA accepts Opus Genetics sNDA for phentolamine ophthalmic solution 0.75% to treat presbyopia","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      FDA accepts <a href=\"https://laohu8.com/S/IRD\">Opus Genetics</a> sNDA for phentolamine ophthalmic solution 0.75% to treat presbyopia\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Opus Genetics Inc. said the U.S. Food and Drug Administration has accepted for review its supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia. The agency set a PDUFA goal date of Oct. 17, 2026. The product, marketed as Ryzumvi, is currently approved in the U.S. for reversal of pharmacologically induced mydriasis, and the filing seeks to expand its indication; Viatris holds exclusive U.S. commercialization rights under a licensing agreement.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Opus Genetics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202602250659PRIMZONEFULLFEED9660292) on February 25, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>FDA accepts Opus Genetics sNDA for phentolamine ophthalmic solution 0.75% to treat presbyopia</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nFDA accepts Opus Genetics sNDA for phentolamine ophthalmic solution 0.75% to treat presbyopia\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time\">2026-02-25 19:59</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      FDA accepts <a href=\"https://laohu8.com/S/IRD\">Opus Genetics</a> sNDA for phentolamine ophthalmic solution 0.75% to treat presbyopia\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Opus Genetics Inc. said the U.S. Food and Drug Administration has accepted for review its supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia. The agency set a PDUFA goal date of Oct. 17, 2026. The product, marketed as Ryzumvi, is currently approved in the U.S. for reversal of pharmacologically induced mydriasis, and the filing seeks to expand its indication; Viatris holds exclusive U.S. commercialization rights under a licensing agreement.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Opus Genetics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202602250659PRIMZONEFULLFEED9660292) on February 25, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4112","symbol_name":"金融交易所和数据","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260225:nNDL9FdXLD:1","article_id":"2614899120","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2614899120","pubTimestamp":1772020761,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Opus Genetics Inc. said the U.S. Food and Drug Administration has accepted for review its supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia. The agency set a PDUFA goal date of Oct. 17, 2026. The product, marketed as Ryzumvi, is currently approved in the U.S. for reversal of pharmacologically induced mydriasis, and the filing seeks to expand its indication; Viatris holds exclusive U.S. commercialization rights under a licensing agreement.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4112":"金融交易所和数据","IE00B64PRP62.GBP":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (GBP) ACC","LU2095319765.USD":"Natixis Thematics Subscription Economy R/A USD","BK4007":"制药","SG9999014039.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) INC","IE00B3QW5Z07.USD":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (USD) ACC","BK4583":"猴痘概念","IE00BKPKM429.USD":"NEUBERGER BERMAN GLOBAL SUSTAINABLE EQUITY \"A\" (USD) ACC","LU2210150020.SGD":"Natixis Thematics Subscription Economy R/A SGD","SG9999014021.USD":"UNITED GLOBAL DURABLE EQUITIES (USDHDG) ACC","IE00BGHQF748.EUR":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","SG9999014005.SGD":"United Global Durable Equities Fund Acc SGD","SG9999014013.SGD":"United Global Durable Equities Fund Dis SGD","LU2210149790.SGD":"Natixis Thematics Subscription Economy R/A SGD-H","LU1839511570.USD":"WELLS FARGO GLOBAL FACTOR ENHANCED EQUITY \"I\" (USD) ACC","NDAQ":"纳斯达克OMX交易所","LU0314104364.USD":"MANULIFE GF AMERICAN GROWTH \"AA\" (USD) INC","BK4585":"ETF&股票定投概念","VTRS":"Viatris Inc.","BK4139":"生物科技","LU2087621335.USD":"ALLSPRING GLOBAL FACTOR ENHANCED EQUITY \"A\" (USD) ACC","IRD":"OPUS GENETICS INC","BK4588":"碎股"},"translate_title":"FDA接受Opus Genetics 0.75%酚妥拉明滴眼液治疗老花眼的sNDA","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"VTRS":0.9,"IRD":0.9,"NDAQ":0.9},"content_text":"FDA accepts Opus Genetics sNDA for phentolamine ophthalmic solution 0.75% to treat presbyopia\n    \n\n        Opus Genetics Inc. said the U.S. Food and Drug Administration has accepted for review its supplemental New Drug Application for phentolamine ophthalmic solution 0.75% to treat presbyopia. The agency set a PDUFA goal date of Oct. 17, 2026. The product, marketed as Ryzumvi, is currently approved in the U.S. for reversal of pharmacologically induced mydriasis, and the filing seeks to expand its indication; Viatris holds exclusive U.S. commercialization rights under a licensing agreement.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Opus Genetics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202602250659PRIMZONEFULLFEED9660292) on February 25, 2026, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"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,"tenantId":"TBGLOBAL","deviceId":"web-server-community-laohu8-v3","version":"4.36.2","shortVersion":"4.36.2","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/2614899120","isCrawlerRequest":true}