{"id":14784,"date":"2026-01-31T04:09:48","date_gmt":"2026-01-31T04:09:48","guid":{"rendered":"https:\/\/diyhaven858.wasmer.app\/index.php\/fda-clears-investigational-new-drug-application-for-er-100\/"},"modified":"2026-01-31T04:09:48","modified_gmt":"2026-01-31T04:09:48","slug":"fda-clears-investigational-new-drug-application-for-er-100","status":"publish","type":"post","link":"https:\/\/diyhaven858.wasmer.app\/index.php\/fda-clears-investigational-new-drug-application-for-er-100\/","title":{"rendered":"FDA clears investigational new drug application for ER-100"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div data-component=\"ArticleContent\">\n<div class=\"article__below-title\">\n<div class=\" article__posted-date\">\n<p>January 30, 2026<\/p>\n<p>1 min read<\/p>\n<\/p><\/div>\n<div class=\"mobile-trust-box\">\n<div class=\"row\">\n<div class=\"col-12 col-md-5 d-xl-none\">\n<div class=\"trust-box\">\n<div class=\"trust-box-logo d-none d-md-block\">\n          <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/osn.svg?la=en&amp;h=32&amp;w=145&amp;hash=C099A5ADC410818ECDF2097A4CD3C51F\" class=\"logo-img\" height=\"32\" alt=\"occular surgery news logo\" width=\"145\"\/>\n        <\/div>\n<\/p><\/div>\n<\/p><\/div>\n<div class=\"col-12 col-md-6 offset-md-1 offset-xl-0 col-xl-12\">\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"CME Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"\" data-module-track-label=\"\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse u6515a05dffcc4557bdb505f709042d8c\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong>  <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Back to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<h2>Key takeaways:<\/h2>\n<ul>\n<li>ER-100 is the first cellular rejuvenation therapy to receive clearance for human clinical trials.<\/li>\n<li>A phase 1 study will focus on open-angle glaucoma and nonarteritic anterior ischemic optic neuropathy.<\/li>\n<\/ul>\n<p>Life Biosciences plans to begin human clinical trials of a cellular rejuvenation therapy in optic neuropathies after receiving FDA clearance of an investigational new drug application, according to a press release.<\/p>\n<p>ER-100 aims to modify the epigenome of cells to restore injured cells without changing their underlying DNA sequence, according to the release.<\/p>\n<figure class=\"figure article__og-image\">&#13;\n    <picture>&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/rheumatology\/f\/fda_cleared_healio_23007093.webp?w=476\" media=\"(max-width: 768px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/rheumatology\/f\/fda_cleared_healio_23007093.webp?w=800\" media=\"(max-width: 992px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/rheumatology\/f\/fda_cleared_healio_23007093.webp?w=595\" media=\"(max-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/rheumatology\/f\/fda_cleared_healio_23007093.webp?w=476\" media=\"(min-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/rheumatology\/f\/fda_cleared_healio_23007093.webp?w=476\">&#13;<br \/>\n&#13;<br \/>\n      <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/rheumatology\/f\/fda_cleared_healio_23007093.jpg?w=800\" alt=\"Image: Healio\" class=\"figure-img img-fluid\" width=\"800\"\/>&#13;<br \/>\n    <\/source><\/source><\/source><\/source><\/source><\/picture>&#13;<figcaption class=\"figure-caption\">&#13;<br \/>\n      Life Biosciences plans to begin human clinical trials of a cellular rejuvenation therapy in optic neuropathies after receiving FDA clearance of an investigational new drug application.&#13;<br \/>\n    <\/figcaption>&#13;<br \/>\n  <\/figure>\n<p>\u201cFor eye care providers, ER-100 represents a fundamentally new approach to treating optic neuropathies as it targets retinal ganglion cell health rather than focusing on downstream factors such as intraocular pressure,\u201d <b>Sharon Rosenzweig-Lipson, PhD, <\/b>chief scientific officer at Life Biosciences, told Healio. \u201cIn diseases like open-angle glaucoma, clinicians often see continued neurodegeneration despite standard-of-care management, leaving limited options once damage has begun. In nonarteritic anterior ischemic optic neuropathy, there are no approved treatments.\u201d<\/p>\n<p>The company said ER-100 is the first therapy of its kind to receive FDA clearance to begin human clinical trials. Life Biosciences will enroll participants with open-angle glaucoma and nonarteritic anterior ischemic optic neuropathy in a phase 1 study to assess the therapy\u2019s safety, tolerability, immune responses and impact on visual assessments, according to the release.<\/p>\n<div class=\"mug left\"><img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/ophthalmology\/mugs\/r\/rosenzweig-lipson_sharon_80x106.jpg?h=106&amp;w=80\" style=\"width: 80px; height: 106px;\"\/><\/p>\n<p><strong>Sharon Rosenzweig-Lipson<\/strong><\/p>\n<\/div>\n<p>\u201cIn the near term, Life Biosciences is focused on executing the phase 1 clinical study, with an emphasis on safety and then exploratory efficacy readouts,\u201d Rosenzweig-Lipson said. \u201cThese data will guide dose selection and inform the design of subsequent studies. We believe our partial epigenetic reprogramming platform has broad potential beyond the eye, and preclinical data already suggest applicability beyond ophthalmology, including in metabolic and liver diseases.\u201d<\/p>\n<div class=\"article__content--footer\">\n<div class=\"publisher-logo\">\n    <span>Published by:<\/span><br \/>\n    <img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/h5\/feature\/news\/publogos\/osn.svg?la=en&amp;h=32&amp;w=145&amp;hash=C099A5ADC410818ECDF2097A4CD3C51F\" class=\"logo-img\" height=\"32\" alt=\"occular surgery news logo\" width=\"145\"\/>\n  <\/div>\n<div class=\"sources-references-disclosures\">\n<h3>Sources\/Disclosures<\/h3>\n<h2> Source: <\/h2>\n<p class=\"citation\">Press Release<\/p>\n<div class=\"disclosures\">\n<p>&#13;<br \/>\n        <strong> Disclosures: <\/strong>&#13;<br \/>\n        Rosenzweig-Lipson reports being chief scientific officer at Life Biosciences.&#13;\n      <\/p>\n<\/p><\/div>\n<\/div>\n<p><!-- Healio AI Widget --><\/p>\n<div class=\"healio-ai-component-inline\" data-no-ads=\"true\" data-module-track-category=\"Healio AI\" data-module-track-action=\"Click\" data-module-track-label=\"Access Healio Ai from component - News_AI Component - In-Content (all devices)\">\n<div class=\"healio-ai-content\">\n    <img decoding=\"async\" src=\"https:\/\/m3.healio.com\/~\/media\/images\/healio-ai\/healio-ai_logo.svg\" alt=\"Healio AI\" class=\"healio-ai-logo\"\/><\/p>\n<p><strong>Ask a clinical question<\/strong> and tap into <strong>Healio AI&#8217;s knowledge<\/strong> base.<\/p>\n<ul>&#13;<\/p>\n<li>PubMed, enrolling\/recruiting trials, guidelines<\/li>\n<p>&#13;<\/p>\n<li>Clinical Guidance, Healio CME, FDA news<\/li>\n<p>&#13;<\/p>\n<li>Healio&#8217;s exclusive daily news coverage of clinical data<\/li>\n<p>&#13;\n    <\/ul>\n<p>    <button class=\"healio-ai-button\" onclick=\"window.location.href=\" https:=\"\">Learn more<\/button>\n  <\/div>\n<\/div>\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"CME Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"\" data-module-track-label=\"\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse u6515a05dffcc4557bdb505f709042d8c\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. 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