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2021-12-21

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Aldeyra's Dry Eye Disease Candidate Disappoints In Late-Stage Study

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

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}\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\">\nAldeyra's Dry Eye Disease Candidate Disappoints In Late-Stage Study\n</h2>\n\n<h4 class=\"meta\">\n\n\n<div class=\"head\" \">\n\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\">2021-12-21 19:16</p>\n</div>\n\n</div>\n\n\n</h4>\n\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>\n<ul>\n <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>\n <li>Statistical significance was also achieved for the post-hoc assessment of Schirmer test responders of over 10 mm.</li>\n <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>\n <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>\n <li>The company intends to file the marketing application for dry eye disease indication in mid-2022.</li>\n <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>\n <li>No safety signals were observed, and reproxalap was well tolerated; there were no treatment-related discontinuations or moderate or severe adverse events.</li>\n <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>\n</ul>\n<p><img src=\"https://static.tigerbbs.com/b2918c536ca5a074f762901ace4764fc\" tg-width=\"710\" tg-height=\"614\" width=\"100%\" height=\"auto\"></p>\n\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":1023,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"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":11,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"hasMoreComment":false,"orderType":2}