{"id":48854,"date":"2022-09-27T14:01:38","date_gmt":"2022-09-27T12:01:38","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/iveric-bio-to-present-top-line-results-for-avacincaptad-pegol-from-phase-3-gather2-clinical-trial-in-geographic-atrophy-at-aao-2022-annual-meeting\/"},"modified":"2022-09-27T14:01:38","modified_gmt":"2022-09-27T12:01:38","slug":"iveric-bio-to-present-top-line-results-for-avacincaptad-pegol-from-phase-3-gather2-clinical-trial-in-geographic-atrophy-at-aao-2022-annual-meeting","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/iveric-bio-to-present-top-line-results-for-avacincaptad-pegol-from-phase-3-gather2-clinical-trial-in-geographic-atrophy-at-aao-2022-annual-meeting\/","title":{"rendered":"Iveric Bio to Present Top-line Results for Avacincaptad Pegol from Phase 3 GATHER2 Clinical Trial in Geographic Atrophy at AAO 2022 Annual Meeting"},"content":{"rendered":"<div>\n<p>\n\u00a0\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220926005525\/en\/1151895\/4\/Iveric_Bio_Logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220926005525\/en\/1151895\/21\/Iveric_Bio_Logo.jpg\"><\/a><\/p>\n<p>PARSIPPANY, N.J.&#8211;(BUSINESS WIRE)&#8211;<a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.ivericbio.com&amp;esheet=52925835&amp;newsitemid=20220926005525&amp;lan=en-US&amp;anchor=IVERIC+bio%2C+Inc.&amp;index=1&amp;md5=a1b218e819ac7e2fa00dfb278e71edd6\" rel=\"nofollow noopener\" shape=\"rect\">IVERIC bio, Inc.<\/a> (Nasdaq: ISEE) announced today that top-line efficacy and safety results from GATHER2, the Company\u2019s second Phase 3 clinical trial of avacincaptad pegol (ACP, also known as Zimura<sup>\u00ae<\/sup>), an investigational complement C5 inhibitor being evaluated for the treatment of geographic atrophy (GA), will be presented at the American Academy of Ophthalmology 2022 annual meeting (AAO 2022) in Chicago, September 30 \u2013 October 3. Following previously announced positive topline findings, this is the first time GATHER2 results for avacincaptad pegol will be presented at a medical congress.\n<\/p>\n<p>\n\u201cWe look forward to engaging with the professional eye care community at AAO 2022 and presenting findings from GATHER2, our second pivotal study of avacincaptad pegol in geographic atrophy,\u201d stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. &#8220;We are excited to have achieved something that has never been done before in GA \u2013 deliver two Phase 3 studies that met their pre-specified, primary endpoint at 12 months of slowing GA progression. We are committed to moving forward with our plan to submit a new drug application to the FDA by the end of the first quarter of 2023 and bringing a potential new treatment for GA to physicians and their patients.\u201d\n<\/p>\n<p>\nThe findings will be presented during an oral session titled, \u201cFirst-time Results of Clinical Trials,\u201d as part of Retina Subspecialty Day 1. Details of the presentations are as follows:\n<\/p>\n<p>\n<b>Presentation Title:<\/b> GATHER2 Pivotal Phase 3 Study Results:<b> <\/b>Efficacy of Intravitreal Avacincaptad Pegol in Geographic Atrophy\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\n<b>Presenter:<\/b> Arshad M. Khanani, MD, MA, FASRS, Director of Clinical Research at Sierra Eye Associates, Reno, Nevada\n<\/li>\n<li>\n<b>Date\/Time:<\/b> September 30, 2022 \/ 4:18 PM\n<\/li>\n<\/ul>\n<p>\n<b>Presentation Title:<\/b> GATHER2 Pivotal Phase 3 Study Results: Safety of Intravitreal Avacincaptad Pegol in Geographic Atrophy\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\n<b>Presenter:<\/b> Jeffrey S. Heier, MD, Co-President &amp; Medical Director, Ophthalmic Consultants of Boston, Boston, MA\n<\/li>\n<li>\n<b>Date\/Time:<\/b> September 30, 2022 \/ 4:24 PM\n<\/li>\n<\/ul>\n<p>\n\u201cWe would like to thank the American Academy of Ophthalmology for the opportunity to share the results of GATHER2 with eye care specialists from around the world at the 2022 annual meeting,\u201d said Pravin U. Dugel, MD, President of Iveric Bio. \u201cGeographic atrophy is a debilitating disease, for which there are no currently approved treatments. We believe avacincaptad pegol has the potential to be life-changing for patients with GA.\u201d\n<\/p>\n<p>\nIveric Bio will make the slide presentations available in the Investors section of the company\u2019s Web site following the presentations.\n<\/p>\n<p>\n<b>About Geographic Atrophy<\/b>\n<\/p>\n<p>\nAge-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and\/or atrophy of retinal tissue. Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients. There are currently no U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approved treatment options available for patients with geographic atrophy.\n<\/p>\n<p>\n<b>About Avacincaptad Pegol<\/b>\n<\/p>\n<p>\nAvacincaptad pegol (also known as ACP or Zimura<sup>\u00ae<\/sup>) is an investigational drug that has not been evaluated for safety or efficacy in any country. ACP is a novel complement C5 protein inhibitor. Overactivity of the complement system and the C5 protein are suspected to play a critical role in the development and growth of scarring and vision loss associated with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). By targeting C5, ACP has the potential to decrease activity of the complement system that causes the degeneration of retinal cells and potentially slow the progression of GA.\n<\/p>\n<p>\n<b>About the GATHER2 Clinical Trial<\/b>\n<\/p>\n<p>\nIn GATHER2, 448 participants were enrolled in the international, randomized, double-masked, sham-controlled, multicenter clinical trial to measure the efficacy and safety of monthly 2 mg intravitreal administration of ACP in patients with GA. For the first 12 months, patients were randomized to receive either ACP 2 mg or sham monthly. At 12 months, participants in the ACP arm were re-randomized to either receive ACP 2 mg once monthly or every other month until month 23 of the study. The final evaluation will take place at month 24.\n<\/p>\n<p>\n<b>About Iveric Bio<\/b>\n<\/p>\n<p>\nIveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs. The Company is committed to having a positive impact on patients\u2019 lives by delivering high-quality, safe and effective treatments designed to address debilitating retinal diseases including earlier stages of age-related macular degeneration. For more information on the Company, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.ivericbio.com&amp;esheet=52925835&amp;newsitemid=20220926005525&amp;lan=en-US&amp;anchor=www.ivericbio.com&amp;index=2&amp;md5=c1a5d185ec449fa423e597960ca048f5\" rel=\"nofollow noopener\" shape=\"rect\">www.ivericbio.com<\/a>.\n<\/p>\n<p>\n<b><i>Forward-looking Statements<\/i><\/b>\n<\/p>\n<p>\n<i>Any statements in this press release about the Company\u2019s future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company\u2019s strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words \u201canticipate,\u201d \u201cbelieve,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cintend\u201d, \u201cgoal,\u201d \u201cmay\u201d, \u201cmight,\u201d \u201cplan,\u201d \u201cpredict,\u201d \u201cproject,\u201d \u201cseek,\u201d \u201ctarget,\u201d \u201cpotential,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201ccould,\u201d \u201cshould,\u201d \u201ccontinue,\u201d and similar expressions. In this press release, the Company\u2019s forward-looking statements include statements about its expectations regarding the results and implications of the clinical data from its GATHER2 trial of ACP in geographic atrophy, its development and regulatory strategy for ACP, including its plans to submit a new drug application to the U.S. Food and Drug Administration, and the potential utility of ACP in treating geographic atrophy. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company\u2019s development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to expectations for regulatory matters, interpretation of clinical trial results by the scientific and medical community, developments from the Company\u2019s competitors and the marketplace for the Company\u2019s products, and other factors discussed in the \u201cRisk Factors\u201d section contained in the quarterly and annual reports that the Company files with the Securities and Exchange Commission. Any forward-looking statements represent the Company\u2019s views only as of the date of this press release. The Company anticipates that subsequent events and developments may cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.<\/i>\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Investor:<\/b><br \/>Kathy Galante<br \/>\n<br \/>Senior Vice President, Investor Relations<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#x61;&#105;&#108;&#116;o&#x3a;&#x6b;&#x61;&#116;&#104;y&#46;&#x67;&#x61;&#x6c;&#97;&#110;t&#x65;&#x40;&#x69;&#118;&#101;&#114;i&#x63;&#x62;&#x69;&#111;&#46;co&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#107;a&#x74;h&#x79;&#46;&#x67;a&#x6c;&#97;&#x6e;&#116;&#x65;&#64;&#x69;&#118;e&#114;i&#x63;b&#x69;o&#x2e;&#99;&#x6f;&#109;<\/a><br \/>or<br \/>\n<br \/><b>Media:<\/b><br \/>Jeannie Neufeld<br \/>\n<br \/>Senior Director, Public Relations &amp; Communications<br \/>\n<br \/><a target=\"_blank\" href=\"mailto:j&#101;&#97;&#110;&#110;&#105;&#101;&#46;&#110;&#101;&#117;&#x66;&#x65;&#x6c;&#x64;&#x40;&#x69;&#x76;&#x65;&#x72;&#x69;&#x63;&#x62;&#x69;&#x6f;&#x2e;com\" rel=\"nofollow noopener\" shape=\"rect\">&#106;&#x65;a&#x6e;n&#105;&#x65;&#46;&#x6e;e&#117;&#x66;&#101;&#x6c;d&#x40;&#x69;&#118;&#x65;r&#x69;c&#98;&#x69;&#111;&#x2e;c&#111;&#x6d;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u00a0 PARSIPPANY, N.J.&#8211;(BUSINESS WIRE)&#8211;IVERIC bio, Inc. (Nasdaq: ISEE) announced today that top-line efficacy and safety results from GATHER2, the Company\u2019s second Phase 3 clinical trial of avacincaptad pegol (ACP, also known as Zimura\u00ae), an investigational complement C5 inhibitor being evaluated for the treatment of geographic atrophy (GA), will be presented at the American Academy of &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/iveric-bio-to-present-top-line-results-for-avacincaptad-pegol-from-phase-3-gather2-clinical-trial-in-geographic-atrophy-at-aao-2022-annual-meeting\/\">[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":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-48854","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Iveric Bio to Present Top-line Results for Avacincaptad Pegol from Phase 3 GATHER2 Clinical Trial in Geographic Atrophy at AAO 2022 Annual Meeting - 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\/iveric-bio-to-present-top-line-results-for-avacincaptad-pegol-from-phase-3-gather2-clinical-trial-in-geographic-atrophy-at-aao-2022-annual-meeting\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Iveric Bio to Present Top-line Results for Avacincaptad Pegol from Phase 3 GATHER2 Clinical Trial in Geographic Atrophy at AAO 2022 Annual Meeting - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"\u00a0 PARSIPPANY, N.J.&#8211;(BUSINESS WIRE)&#8211;IVERIC bio, Inc. (Nasdaq: ISEE) announced today that top-line efficacy and safety results from GATHER2, the Company\u2019s second Phase 3 clinical trial of avacincaptad pegol (ACP, also known as Zimura\u00ae), an investigational complement C5 inhibitor being evaluated for the treatment of geographic atrophy (GA), will be presented at the American Academy of ... 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(Nasdaq: ISEE) announced today that top-line efficacy and safety results from GATHER2, the Company\u2019s second Phase 3 clinical trial of avacincaptad pegol (ACP, also known as Zimura\u00ae), an investigational complement C5 inhibitor being evaluated for the treatment of geographic atrophy (GA), will be presented at the American Academy of ... 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