{"id":765038,"date":"2023-06-21T08:19:33","date_gmt":"2023-06-21T12:19:33","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/"},"modified":"2023-06-21T08:19:33","modified_gmt":"2023-06-21T12:19:33","slug":"ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/","title":{"rendered":"Ocuphire Announces Late Breaking Presentation on APX3330 ZETA-1 Clinical Data at American Diabetes Association Annual Conference"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"left\">FARMINGTON HILLS, Mich., June  21, 2023  (GLOBE NEWSWIRE) &#8212; Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of retinal and refractive eye disorders, today announced that Victor H. Gonzalez, MD will present a late breaking poster and ePoster theater presentation titled <em>Oral APX3330 Reduces the DRSS Worsening after 24-weeks of Daily Treatment\u2014Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy<\/em> at the <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=TdFwHzbEOtv2P4iIL5Fu5ykNAVRl90ZeZFvXpId3zPqrFSzTih77S8B0RofxeGt_hSO95qBOJHCIQpOpYcNH8vjOsWDHT-JQKZ4GMPhkFeUt7S78CY6xFOQuzM9G9IRyt-V9LQye8DJV9Aijps8CMFniX8SyULQ3atrfzLVD5-ZL-xmKMYXbhd6jNGVGTEGL\" rel=\"nofollow noopener\" target=\"_blank\">83<sup>rd <\/sup>Scientific Sessions of the American Diabetes Association (ADA)<\/a>, in San Diego, CA, June 23-26.<\/p>\n<p>\n        <u>Poster details<\/u>\n      <\/p>\n<table style=\"border-collapse: collapse;width:100%;border-collapse:collapse\">\n<tr>\n<td style=\"max-width:15%;width:15%;min-width:15%;vertical-align: top\">Title:<\/td>\n<td style=\"max-width:5%;width:5%;min-width:5%\">\u00a0<\/td>\n<td style=\"max-width:80%;width:80%;min-width:80%;vertical-align: top\">Oral APX3330 Reduces the DRSS Worsening after 24-weeks of Daily Treatment\u2014Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Date \/ time:<\/td>\n<td>\u00a0<\/td>\n<td style=\"vertical-align: top\">Saturday June 24, 11:30am to 12:30pm PT<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Location:<\/td>\n<td>\u00a0<\/td>\n<td style=\"vertical-align: top\">Poster Halls B-C<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Session:<\/td>\n<td>\u00a0<\/td>\n<td style=\"vertical-align: top\">Late Breaking Posters<\/td>\n<\/tr>\n<tr>\n<td style=\"vertical-align: top\">Presenter:<\/td>\n<td>\u00a0<\/td>\n<td style=\"vertical-align: top\">Victor H. Gonzalez MD, Valley Retina Institute<\/td>\n<\/tr>\n<\/table>\n<p>An ePoster theater presentation highlighting ZETA-1 data will be featured in the \u201cNew Approaches and Renewing the Old\u201d session, 4:30pm &#8211; 6:00pm PT on Saturday, June 24 in the Exhibit Hall (ePoster Theater B).<\/p>\n<p>\n        <strong>About Ocuphire Pharma<\/strong>\n      <\/p>\n<p>Ocuphire is a publicly traded (Nasdaq: OCUP), clinical-stage, ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders.<\/p>\n<p>Ocuphire\u2019s lead late-stage product candidate, APX3330, is a first-in-class, small molecule oral drug that blocks downstream pathways regulated by transcription factor Ref-1 \u2013 including those involving angiogenesis (VEGF) and inflammation (NFkB). These pathways are implicated in several ocular diseases, including diabetic retinopathy (DR), diabetic macular edema (DME), and age-related macular degeneration (AMD). Ocuphire recently announced topline data from the ZETA-1 Phase 2 trial in which APX3330 achieved statistical significance on a key pre-specified secondary endpoint of preventing clinically meaningful progression of DR after 24 weeks of daily treatment. APX3330 has also shown a favorable safety and tolerability profile in diabetic subjects (ZETA-1 trial) and in 11 previous clinical trials conducted in healthy, liver disease, and cancer subjects. An End-of-Phase 2 meeting with the FDA is planned for APX3330.<\/p>\n<p>Ocuphire has a partnership with Viatris, Inc. to develop and commercialize Nyxol<sup>\u00ae<\/sup>\u00a0eye drops as a preservative-free eye drop formulation of phentolamine mesylate, a non-selective alpha-1 and alpha-2 adrenergic antagonist designed to reduce pupil size by uniquely blocking the alpha-1 receptors found only on the iris dilator muscle without affecting the ciliary muscle. Nyxol has been studied in a total of 12 clinical trials across three indications, reversal of pharmacologically-induced mydriasis (RM), presbyopia and dim light (night) vision disturbances (DLD). Nyxol\u2019s NDA under the 505(b)(2) pathway for the first indication, RM, has been accepted with a PDUFA date assigned of September 28, 2023. Nyxol is currently in Phase 3 for presbyopia and DLD.<\/p>\n<p>For more information, visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=eIZx9YEaHVvz80cPASxQo6ivKtI01VHU65IcdSbUJmc3s5LTfR7RHkt-cjxgoHRnWH3E9VHh451Otkp3jtrdmtCLE53qd0d-CWGRcI_ChixETodGDMMeqtyoO1kGjCj9v-Hh0Sag8VE0HUhB6f8D_bkZHXJJp8n3NFMsmIBAhYzEdjff8tdp7JXigexWKUy8OrlP4PMfWVeoE01vRHS-nR9wBfsEAI0oo0jHlCP50dBb4GY0PE5tJnA70XSE5o_edfpdR1vv_4PyRC5wIYvfTZaZ4Cbb-ci9W04Z3KvnsPv0iwhoK1uK18Yp-uf5SwTAjsYlIz53OGPCKR8QbR_g1z1MLv616cdVrvDGMOeRCEbWCmbRUKCQvucmvItrn3FrRITHcTV8zkg6SRdl7sadtqEsUfIFEkOIj0Co8uto5ex_cXthwNYjfDzMqono-r-scN_Zg7_9EFGttfNoP780t62hisI5W-tXX_yrPX2SM4g_JBGw0Nh0CngcHd8pQk97wF8oSU_owOU68282ikTGdYEESgIClbGsEBNvQ5KPIqcNxgmx6HTNNlXZMdQL9BirFeU-9M5LGZpj2Jx655N_0g==\" rel=\"nofollow noopener\" target=\"_blank\">www.ocuphire.com<\/a><\/p>\n<p>\n        <strong>Forward Looking Statements<\/strong>\n      <\/p>\n<p>Statements contained in this press release regarding matters that are not historical facts are \u201cforward-looking statements\u201d within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning the End-of-Phase 2 meeting with the FDA to confirm Phase 3 registration endpoints and study parameters, and the potential receipt of regulatory approval for Nyxol for the treatment of RM. These forward-looking statements are based upon Ocuphire\u2019s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success and timing of regulatory submissions and pre-clinical and clinical trials, including enrollment and data readouts; (ii) regulatory requirements or developments; (iii) changes to clinical trial designs and regulatory pathways; (iv) changes in capital resource requirements; (v) risks related to the inability of Ocuphire to obtain sufficient additional capital to continue to advance its product candidates and its preclinical programs; (vi) legislative, regulatory, political and economic developments, (vii) changes in market opportunities, (viii) the effects of COVID-19 on clinical programs and business operations, (ix) risks that the Nyxol partnership may not facilitate the commercialization or market acceptance of Ocuphire\u2019s product candidates; (x) the success and timing of commercialization of any of Ocuphire\u2019s product candidates and (xi) the maintenance of Ocuphire\u2019s intellectual property rights. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in documents that have been and may be filed by Ocuphire from time to time with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Ocuphire undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.\u00a0<\/p>\n<p>\n        <strong>Contacts<\/strong>\n      <\/p>\n<table style=\"border-collapse: collapse;width:100%;border-collapse:collapse\">\n<tr>\n<td style=\"border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">Corporate\u00a0<\/td>\n<td colspan=\"2\" style=\"border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: middle\">Investor Relations\u00a0<\/td>\n<\/tr>\n<tr>\n<td style=\"border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: top\">Rick Rodgers, MBA\u00a0<br \/>Interim CEO\u00a0<br \/><a href=\"mailto:ir@ocuphire.com\" rel=\"nofollow noopener\" target=\"_blank\">ir@ocuphire.com<\/a>\u00a0<\/td>\n<td style=\"border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: top\">Corey Davis, Ph.D.\u00a0<br \/>LifeSci Advisors\u00a0<br \/><a href=\"mailto:cdavis@lifesciadvisors.com\" rel=\"nofollow noopener\" target=\"_blank\">cdavis@lifesciadvisors.com<\/a><\/td>\n<td style=\"border-top: solid black 1pt;border-right: solid black 1pt;border-bottom: solid black 1pt;border-left: solid black 1pt;text-align: center;vertical-align: middle;vertical-align: top\">Bret Shapiro\u00a0<br \/>CoreIR\u00a0<br \/><a href=\"mailto:brets@coreir.com\" rel=\"nofollow noopener\" target=\"_blank\">brets@coreir.com<\/a><\/td>\n<\/tr>\n<\/table>\n<p>      <img decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg2MjAxOSM1NjU3MjQxIzUwMDA3Mzk4OA==\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" src=\"https:\/\/ml.globenewswire.com\/media\/MDE2NTBlOTktYTc2Mi00ZWZiLTg5ZDAtZDRiMDlhNWI3NGYwLTUwMDA3Mzk4OA==\/tiny\/Ocuphire-Pharma.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>FARMINGTON HILLS, Mich., June 21, 2023 (GLOBE NEWSWIRE) &#8212; Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of retinal and refractive eye disorders, today announced that Victor H. Gonzalez, MD will present a late breaking poster and ePoster theater presentation titled Oral APX3330 Reduces the DRSS Worsening after 24-weeks of Daily Treatment\u2014Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy at the 83rd Scientific Sessions of the American Diabetes Association (ADA), in San Diego, CA, June 23-26. Poster details Title: \u00a0 Oral APX3330 Reduces the DRSS Worsening after 24-weeks of Daily Treatment\u2014Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy Date &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Ocuphire Announces Late Breaking Presentation on APX3330 ZETA-1 Clinical Data at American Diabetes Association Annual Conference&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-765038","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Ocuphire Announces Late Breaking Presentation on APX3330 ZETA-1 Clinical Data at American Diabetes Association Annual Conference - Market Newsdesk<\/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:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Ocuphire Announces Late Breaking Presentation on APX3330 ZETA-1 Clinical Data at American Diabetes Association Annual Conference - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"FARMINGTON HILLS, Mich., June 21, 2023 (GLOBE NEWSWIRE) &#8212; Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of retinal and refractive eye disorders, today announced that Victor H. Gonzalez, MD will present a late breaking poster and ePoster theater presentation titled Oral APX3330 Reduces the DRSS Worsening after 24-weeks of Daily Treatment\u2014Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy at the 83rd Scientific Sessions of the American Diabetes Association (ADA), in San Diego, CA, June 23-26. Poster details Title: \u00a0 Oral APX3330 Reduces the DRSS Worsening after 24-weeks of Daily Treatment\u2014Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy Date &hellip; Continue reading &quot;Ocuphire Announces Late Breaking Presentation on APX3330 ZETA-1 Clinical Data at American Diabetes Association Annual Conference&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2023-06-21T12:19:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg2MjAxOSM1NjU3MjQxIzUwMDA3Mzk4OA==\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Ocuphire Announces Late Breaking Presentation on APX3330 ZETA-1 Clinical Data at American Diabetes Association Annual Conference\",\"datePublished\":\"2023-06-21T12:19:33+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\\\/\"},\"wordCount\":836,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.globenewswire.com\\\/newsroom\\\/ti?nf=ODg2MjAxOSM1NjU3MjQxIzUwMDA3Mzk4OA==\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\\\/\",\"name\":\"Ocuphire Announces Late Breaking Presentation on APX3330 ZETA-1 Clinical Data at American Diabetes Association Annual Conference - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/","og_locale":"en_US","og_type":"article","og_title":"Ocuphire Announces Late Breaking Presentation on APX3330 ZETA-1 Clinical Data at American Diabetes Association Annual Conference - Market Newsdesk","og_description":"FARMINGTON HILLS, Mich., June 21, 2023 (GLOBE NEWSWIRE) &#8212; Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing therapies for the treatment of retinal and refractive eye disorders, today announced that Victor H. Gonzalez, MD will present a late breaking poster and ePoster theater presentation titled Oral APX3330 Reduces the DRSS Worsening after 24-weeks of Daily Treatment\u2014Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy at the 83rd Scientific Sessions of the American Diabetes Association (ADA), in San Diego, CA, June 23-26. Poster details Title: \u00a0 Oral APX3330 Reduces the DRSS Worsening after 24-weeks of Daily Treatment\u2014Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy Date &hellip; Continue reading \"Ocuphire Announces Late Breaking Presentation on APX3330 ZETA-1 Clinical Data at American Diabetes Association Annual Conference\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/","og_site_name":"Market Newsdesk","article_published_time":"2023-06-21T12:19:33+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg2MjAxOSM1NjU3MjQxIzUwMDA3Mzk4OA==","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"4 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Ocuphire Announces Late Breaking Presentation on APX3330 ZETA-1 Clinical Data at American Diabetes Association Annual Conference","datePublished":"2023-06-21T12:19:33+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/"},"wordCount":836,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/#primaryimage"},"thumbnailUrl":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODg2MjAxOSM1NjU3MjQxIzUwMDA3Mzk4OA==","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/ocuphire-announces-late-breaking-presentation-on-apx3330-zeta-1-clinical-data-at-american-diabetes-association-annual-conference\/","name":"Ocuphire Announces Late Breaking Presentation on APX3330 ZETA-1 Clinical Data at American Diabetes Association Annual Conference - 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