{"id":78513,"date":"2026-09-03T17:10:19","date_gmt":"2026-09-03T09:10:19","guid":{"rendered":"https:\/\/flcube.com\/?p=78513"},"modified":"2026-09-03T17:10:20","modified_gmt":"2026-09-03T09:10:20","slug":"ocumension-completes-enrollment-in-china-phase-iii-trial-of-ot-211-for-dry-eye-disease-aligned-with-global-comet-pivotal-program","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=78513","title":{"rendered":"Ocumension Completes Enrollment in China Phase III Trial of OT\u2011211 for Dry Eye Disease, Aligned with Global COMET Pivotal Program"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Ocumension Therapeutics<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/1477:HKG\">HKG: 1477<\/a>) announced that all subjects have been enrolled as scheduled in the Chinese Phase III clinical trial of <strong>OT\u2011211<\/strong> (TRYPTYR, acotremon ophthalmic solution), a novel therapy for <strong>dry eye disease<\/strong>. The milestone keeps the China registrational program of <strong>OT\u2011211<\/strong> \u2014 the world&#8217;s first TRPM8 receptor agonist approved for <strong>dry eye disease<\/strong>, introduced into China under a strategic partnership between <strong>Ocumension<\/strong> and <strong>Alcon<\/strong> \u2014 on track with the asset&#8217;s global pivotal studies.<\/p>\n\n\n\n<h2 id=\"h-trial-design-china-phase-iii-study-of-ot-211\" class=\"wp-block-heading\">Trial Design \u2013 China Phase III Study of OT\u2011211<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td>Phase \/ Design<\/td><td>Phase III, randomized, double\u2011blind, vehicle\u2011controlled, parallel\u2011group, multicenter study<\/td><\/tr><tr><td>Enrollment<\/td><td>398 subjects with moderate\u2011to\u2011severe <strong>dry eye disease<\/strong> (fully enrolled as scheduled)<\/td><\/tr><tr><td>Primary Endpoint<\/td><td>Proportion of subjects with an increase of \u226510 mm from baseline in unanesthetized Schirmer&#8217;s test score at Day 14<\/td><\/tr><tr><td>Endpoint Alignment<\/td><td>Consistent with the primary endpoints of <strong>OT\u2011211&#8217;s<\/strong> global pivotal Phase III trials (COMET\u20112 and COMET\u20113)<\/td><\/tr><tr><td>Status<\/td><td>Enrollment complete; efficacy and safety evaluation ongoing<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-drug-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Drug Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> <strong>OT\u2011211<\/strong> (TRYPTYR, acotremon ophthalmic solution), a novel ophthalmic therapy for <strong>dry eye disease<\/strong><\/li>\n\n\n\n<li><strong>Target \/ Class:<\/strong> TRPM8 receptor agonist \u2014 the world&#8217;s first TRPM8 agonist approved for the treatment of <strong>dry eye disease<\/strong><\/li>\n\n\n\n<li><strong>Partnership:<\/strong> Introduced into China under a strategic partnership between <strong>Ocumension Therapeutics<\/strong> and <strong>Alcon<\/strong><\/li>\n\n\n\n<li><strong>Global Evidence Base:<\/strong> Primary endpoint harmonized with the global COMET\u20112 and COMET\u20113 pivotal trials, supporting cross\u2011regional data comparability<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Execution on schedule:<\/strong> Full enrollment of the 398\u2011subject study as planned de\u2011risks the China registrational timeline for <strong>OT\u2011211<\/strong> and supports a predictable path toward NMPA submission<\/li>\n\n\n\n<li><strong>First\u2011in\u2011class positioning:<\/strong> As the world&#8217;s first approved TRPM8 receptor agonist for <strong>dry eye disease<\/strong>, <strong>OT\u2011211<\/strong> brings a differentiated mechanism to one of ophthalmology&#8217;s largest and most competitive markets<\/li>\n\n\n\n<li><strong>Bridgeable endpoints:<\/strong> The aligned Schirmer&#8217;s test primary endpoint with COMET\u20112 and COMET\u20113 strengthens the prospect of consistent evidence across the China and global programs<\/li>\n\n\n\n<li><strong>Strategic partnership leverage:<\/strong> The <strong>Ocumension<\/strong>\u2013<strong>Alcon<\/strong> collaboration combines local development strength with global commercial and clinical resources in a condition affecting a large patient population in China<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong> \u2014 This brief contains forward\u2011looking statements regarding the clinical development timeline, trial outcomes, regulatory approval, and commercial potential of <strong>OT\u2011211<\/strong> in <strong>dry eye disease<\/strong>. Actual results may differ materially due to clinical, regulatory, competitive, and market risks. No investment decision should be made solely on the basis of this brief.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Ocumension Therapeutics (HKG: 1477) announced that all subjects have been enrolled as scheduled in the&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[936,156,44],"class_list":["post-78513","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-hkg-1477","tag-ocumension-therapeutics","tag-ophthalmology"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Ocumension Completes Enrollment in China Phase III Trial of OT\u2011211 for Dry Eye Disease, Aligned with Global COMET Pivotal Program - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Ocumension Therapeutics (HKG: 1477) announced that all subjects have been enrolled as scheduled in the Chinese Phase III clinical trial of OT\u2011211 (TRYPTYR, acotremon ophthalmic solution), a novel therapy for dry eye disease. 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