Outlook Therapeutics Files FDA Resolution Request After Rejection For Vision Loss Drug

Benzinga_recent_news04-08

Outlook Therapeutics (NASDAQ:OTLK) announced on Monday that it has submitted a formal dispute resolution request (FDRR) to the U.S. Food and Drug Administration (FDA) regarding its ONS-5010/LYTENAVA. ...

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The CRL included only one deficiency for a lack of substantial evidence of effectiveness.\nIn August 2023, Outlook Therapeutics received a complete response letter from the FDA regarding ONS-5010.\nThe FDA noted that the additional mechanistic and natural history data provided in the BLA resubmission do not alter the previous review conclusion.\nIn the U.S., ONS-5010/LYTENAVA remains investigational, but its potential approval would mark it as the first FDA-approved ophthalmic bevacizumab formulation.\nThe product has already gained approval in Europe. Outlook Therapeutics emphasizes the robust pharmacovigilance and domestic U.S. manufacturing supply chain supporting ONS-5010/LYTENAVA.\nThis positions the company to meet regulatory standards and expand its market presence.\nOTLK Price Action: Outlook Therapeutics shares were up 4.64% at $0.20 at the time of publication on Tuesday. The stock is trading near its 52-week low of $0.16, according to Benzinga Pro data.\nImage via Shutterstock\nTo add Benzinga News as your preferred source on Google, click here.","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":"policyRegulatory","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":0,"need_auth":false,"need_login_tip":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":"4.42.0","shortVersion":"4.42.0","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/2625696863","isCrawlerRequest":true}