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2021-12-22

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Aldeyra's Dry Eye Disease Candidate Disappoints In Late-Stage Study<blockquote>Aldeyra的干眼症候选药物在后期研究中令人失望</blockquote>

Aldeyra Therapeutics Inc reported topline data from Phase 3 TRANQUILITY Trial of reproxalap ophthalm

Aldeyra's Dry Eye Disease Candidate Disappoints In Late-Stage Study<blockquote>Aldeyra的干眼症候选药物在后期研究中令人失望</blockquote>

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The company expects topline results in mid-2022.</li>  <li>The company intends to file the marketing application for dry eye disease indication in mid-2022.</li>  <li>Application for allergic conjunctivitis, another proposed indication, is expected to occur after the dry eye disease submission and following completion of an additional allergen chamber trial requested by the FDA.</li>  <li>No safety signals were observed, and reproxalap was well tolerated; there were no treatment-related discontinuations or moderate or severe adverse events.</li>  <li><b>Price Action:</b>&nbsp;ALDX shares are down 38.29% at $4.4 during the premarket session on the last check Tuesday.</li> </ul> <img src=\"https://static.tigerbbs.com/b2918c536ca5a074f762901ace4764fc\" tg-width=\"710\" tg-height=\"614\" width=\"100%\" height=\"auto\"></p><p><blockquote><ul><li>该试验未能达到眼睛发红的主要终点，但在次要终点Schirmer检验的干眼症体征方面确实达到了统计学意义。</li><li>对超过10 mm的Schirmer试验应答者的事后评估也达到了统计学显著性。</li><li>即将进行的3期TRANQUILITY-2试验的主要终点已被修改，如果Schirmer检验或眼部发红显示出统计学显著性，则达到终点。</li><li>此外，TRANQUILITY-2的目标入组已从300名患者增加到最多400名患者。该公司预计营收将于2022年中期公布。</li><li>公司拟于2022年年中提交干眼症适应症的上市申请。</li><li>过敏性结膜炎（另一个拟定适应症）的申请预计将在提交干眼症后和完成FDA要求的额外过敏原室试验后进行。</li><li>未观察到安全性信号，reproxalap耐受性良好；无治疗相关停药或中度或重度不良事件。</li><li><b>价格走势：</b>周二最后一次盘前交易中，ALDX股价下跌38.29%，至4.4美元。</li></ul></blockquote></p><p></p>","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; 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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: 12.5px; color: #7E829C; margin: 0;}\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\">\nAldeyra's Dry Eye Disease Candidate Disappoints In Late-Stage Study<blockquote>Aldeyra的干眼症候选药物在后期研究中令人失望</blockquote>\n</h2>\n<h4 class=\"meta\">\n<div class=\"head\" \">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/d08bf7808052c0ca9deb4e944cae32aa);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Benzinga </p>\n<p class=\"h-time smaller\">2021-12-21 19:16</p>\n</div>\n</div>\n</h4>\n</header>\n<article>\n<p><b>Aldeyra Therapeutics Inc</b>&nbsp;reported topline data&nbsp;from Phase 3 TRANQUILITY Trial of reproxalap ophthalmic solution for dry eye disease.</p><p><blockquote><b>阿尔代拉治疗公司</b>报告了reproxalap滴眼液治疗干眼症的3期TRANQUILITY试验的顶线数据。</blockquote></p><p> <ul>  <li>The trial failed to meet the primary endpoint of ocular redness, but it did achieve statistical significance for the dry eye disease sign of the Schirmer test, a secondary endpoint.</li>  <li>Statistical significance was also achieved for the post-hoc assessment of Schirmer test responders of over 10 mm.</li>  <li>The primary endpoint of the upcoming Phase 3 TRANQUILITY-2 trial has been modified such that the endpoint will have been met if either the Schirmer test or ocular redness demonstrates statistical significance.</li>  <li>In addition, target enrollment in TRANQUILITY-2 has been increased from 300 to up to 400 patients. The company expects topline results in mid-2022.</li>  <li>The company intends to file the marketing application for dry eye disease indication in mid-2022.</li>  <li>Application for allergic conjunctivitis, another proposed indication, is expected to occur after the dry eye disease submission and following completion of an additional allergen chamber trial requested by the FDA.</li>  <li>No safety signals were observed, and reproxalap was well tolerated; there were no treatment-related discontinuations or moderate or severe adverse events.</li>  <li><b>Price Action:</b>&nbsp;ALDX shares are down 38.29% at $4.4 during the premarket session on the last check Tuesday.</li> </ul> <img src=\"https://static.tigerbbs.com/b2918c536ca5a074f762901ace4764fc\" tg-width=\"710\" tg-height=\"614\" width=\"100%\" height=\"auto\"></p><p><blockquote><ul><li>该试验未能达到眼睛发红的主要终点，但在次要终点Schirmer检验的干眼症体征方面确实达到了统计学意义。</li><li>对超过10 mm的Schirmer试验应答者的事后评估也达到了统计学显著性。</li><li>即将进行的3期TRANQUILITY-2试验的主要终点已被修改，如果Schirmer检验或眼部发红显示出统计学显著性，则达到终点。</li><li>此外，TRANQUILITY-2的目标入组已从300名患者增加到最多400名患者。该公司预计营收将于2022年中期公布。</li><li>公司拟于2022年年中提交干眼症适应症的上市申请。</li><li>过敏性结膜炎（另一个拟定适应症）的申请预计将在提交干眼症后和完成FDA要求的额外过敏原室试验后进行。</li><li>未观察到安全性信号，reproxalap耐受性良好；无治疗相关停药或中度或重度不良事件。</li><li><b>价格走势：</b>周二最后一次盘前交易中，ALDX股价下跌38.29%，至4.4美元。</li></ul></blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"ALDX":"Aldeyra Therapeutics Inc"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1148289841","content_text":"Aldeyra Therapeutics Inc reported topline data from Phase 3 TRANQUILITY Trial of reproxalap ophthalmic solution for dry eye disease.\n\nThe trial failed to meet the primary endpoint of ocular redness, but it did achieve statistical significance for the dry eye disease sign of the Schirmer test, a secondary endpoint.\nStatistical significance was also achieved for the post-hoc assessment of Schirmer test responders of over 10 mm.\nThe primary endpoint of the upcoming Phase 3 TRANQUILITY-2 trial has been modified such that the endpoint will have been met if either the Schirmer test or ocular redness demonstrates statistical significance.\nIn addition, target enrollment in TRANQUILITY-2 has been increased from 300 to up to 400 patients. The company expects topline results in mid-2022.\nThe company intends to file the marketing application for dry eye disease indication in mid-2022.\nApplication for allergic conjunctivitis, another proposed indication, is expected to occur after the dry eye disease submission and following completion of an additional allergen chamber trial requested by the FDA.\nNo safety signals were observed, and reproxalap was well tolerated; there were no treatment-related discontinuations or moderate or severe adverse events.\nPrice Action: ALDX shares are down 38.29% at $4.4 during the premarket session on the last check Tuesday.","news_type":1,"symbols_score_info":{"ALDX":0.9}},"isVote":1,"tweetType":1,"viewCount":1737,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":["BSN.AU"],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":26,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"hasMoreComment":false,"orderType":2}