{"id":53228,"date":"2023-01-24T14:02:36","date_gmt":"2023-01-24T13:02:36","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/oxular-limited-announces-acceptance-of-ind-for-suprachoroidal-oxu-001-for-the-treatment-of-diabetic-macular-edema\/"},"modified":"2023-01-24T14:02:36","modified_gmt":"2023-01-24T13:02:36","slug":"oxular-limited-announces-acceptance-of-ind-for-suprachoroidal-oxu-001-for-the-treatment-of-diabetic-macular-edema","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/oxular-limited-announces-acceptance-of-ind-for-suprachoroidal-oxu-001-for-the-treatment-of-diabetic-macular-edema\/","title":{"rendered":"Oxular Limited Announces Acceptance of IND for Suprachoroidal OXU-001 for the Treatment of Diabetic Macular Edema"},"content":{"rendered":"<div>\n<p class=\"bwalignc\">\n<i>OXU-001 represents potential best-in-class treatment for DME with just one, targeted administration per year<\/i>\n<\/p>\n<p class=\"bwalignc\">\n<i>Initiation of OXEYE Phase 2 clinical trial of OXU-001 in DME patients on-track for first quarter of 2023; Initial clinical data on safety and durability expected in 2023<\/i>\n<\/p>\n<p>OXFORD, United Kingdom&#8211;(BUSINESS WIRE)&#8211;<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Foxular.com%2F&amp;esheet=53289177&amp;newsitemid=20230124005116&amp;lan=en-US&amp;anchor=Oxular+Limited&amp;index=1&amp;md5=96cae71f9684304653d779372ca6a0db\" rel=\"nofollow noopener\" shape=\"rect\">Oxular Limited<\/a>, a clinical-stage ophthalmic company developing long-lasting targeted treatments for retinal disorders to improve patients\u2019 vision, today announced that the U.S. Food and Drug Administration has accepted its Investigational New Drug Application (IND) for suprachoroidal OXU-001 for the treatment of diabetic macular edema (DME). The IND enables advancement of the OXEYE Phase 2 trial, which will evaluate the safety and efficacy of OXU-001 and the potential to provide retinal specialists with a potent, long-lasting, safe, and broad-acting anti-edema and anti-inflammatory treatment for high-prevalence retinal disorders, beginning with DME.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230124005116\/en\/1692923\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230124005116\/en\/1692923\/21\/logo.jpg\"><\/a><\/p>\n<p>\nOXU-001 is dexamethasone formulated in a novel biodegradable drug preparation known as Oxuspheres<sup>\u00ae<\/sup>. OXU-001 will be delivered to the posterior suprachoroidal space of the eye via Oxulumis<sup>\u00ae<\/sup>, Oxular\u2019s proprietary illuminated microcatheter. This in-office treatment could lead to enhanced efficacy, favorable tolerability, and extended durability to address key unmet needs for people with DME and other retinal disorders.\n<\/p>\n<p>\nIn 12-month preclinical studies, OXU-001 was well-tolerated and related pharmacokinetic data confirmed that therapeutic drug levels were consistently maintained in target retinal tissues. These data suggest that a single treatment of OXU-001 may provide up to twelve-month treatment effects with an improved clinical safety profile.\n<\/p>\n<p>\n\u201cThe IND clearance for OXU-001 marks a significant milestone for Oxular,\u201d said Thomas Cavanagh, Chief Executive Officer of Oxular. \u201cDME is the most common and sight-threatening complication of diabetic eye disease and can be debilitating for patients who are often of working age. Today\u2019s treatment approaches have limited durability, requiring frequent anti-VEGF injections into the eye. Also, typically more than two OZURDEX<sup>\u00ae<\/sup> implants per year may be required. The opportunity to provide patients with a targeted, in-office treatment just once a year could be a game-changer for this prevalent disease. We look forward to advancing OXU-001 into the clinic and evaluating its therapeutic impact in 2023.\u201d\n<\/p>\n<p>\n<b>About Oxular<\/b>\n<\/p>\n<p>\nOxular is a biotechnology company developing long-lasting retinal treatments, delivered suprachoroidally, to improve patients\u2019 vision so they can live better lives. The company has engineered sustained-release drug formulations designed to last up to one year following single dosing and delivery technology to access tissues in the posterior suprachoroidal space via routine, in-office administration. This unique combination aims to substantially improve patients\u2019 vision by increasing therapeutic effectiveness, while reducing side-effects and minimizing the frequency of treatments. Oxular is developing a deep portfolio of product candidates that includes treatments for prevalent retinal diseases, such as diabetic macular edema and diabetic retinopathy. For more information, please visit Oxular.com.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nMonique Allaire<br \/>\n<br \/>THRUST Strategic Communications<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;&#105;&#x6c;&#116;&#x6f;:&#x6d;o&#x6e;i&#113;&#x75;&#101;&#x40;&#116;&#x68;&#114;&#x75;s&#x74;s&#x63;&#46;&#99;&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#109;o&#x6e;i&#x71;u&#x65;&#64;&#x74;&#104;&#x72;&#117;&#x73;&#116;&#x73;&#99;&#46;&#99;o&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>OXU-001 represents potential best-in-class treatment for DME with just one, targeted administration per year Initiation of OXEYE Phase 2 clinical trial of OXU-001 in DME patients on-track for first quarter of 2023; Initial clinical data on safety and durability expected in 2023 OXFORD, United Kingdom&#8211;(BUSINESS WIRE)&#8211;Oxular Limited, a clinical-stage ophthalmic company developing long-lasting targeted treatments &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/oxular-limited-announces-acceptance-of-ind-for-suprachoroidal-oxu-001-for-the-treatment-of-diabetic-macular-edema\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":["entry","post","publish","author-business","post-53228","format-standard","category-industry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Oxular Limited Announces Acceptance of IND for Suprachoroidal OXU-001 for the Treatment of Diabetic Macular Edema - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/oxular-limited-announces-acceptance-of-ind-for-suprachoroidal-oxu-001-for-the-treatment-of-diabetic-macular-edema\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Oxular Limited Announces Acceptance of IND for Suprachoroidal OXU-001 for the Treatment of Diabetic Macular Edema - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"OXU-001 represents potential best-in-class treatment for DME with just one, targeted administration per year Initiation of OXEYE Phase 2 clinical trial of OXU-001 in DME patients on-track for first quarter of 2023; Initial clinical data on safety and durability expected in 2023 OXFORD, United Kingdom&#8211;(BUSINESS WIRE)&#8211;Oxular Limited, a clinical-stage ophthalmic company developing long-lasting targeted treatments ... 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