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		<meta data-vue-meta="ssr" property="og:title" content="US FDA Gives Green Light to Trial of i-Lumen’s Bioelectric Stimulation Device for Dry AMD | Market Scope" data-vmid="og:title"><meta data-vue-meta="ssr" property="og:description" content="i-Lumen Scientific announced March 31 that the US FDA had signed off on its investigational device exemption (IDE) submission, allowing the company to proceed with a pivotal trial of its bioelectric stimulation therapy device for dry age-related macular degeneration (AMD). i-Lumen, of Bloomington, Minnesota, said the i-SIGHT2 study is evaluating the effect of i-Lumen&amp;#39;s AMD therapy on visual acuity in patients with intermediate to advanced dry AMD. i-SIGHT2 was already enrolling and treati..." data-vmid="og:description"><meta data-vue-meta="ssr" property="og:url" content="//www.market-scope.com/pages/news/9071/us-fda-gives-green-light-to-trial-of-i-lumen-s-bioelectric-stimulation-device-for-dry-amd" data-vmid="og:url"><meta data-vue-meta="ssr" property="og:type" content="article" data-vmid="og:type"><meta data-vue-meta="ssr" property="article:published_time" content="2026-04-10T00:00:00.000Z" data-vmid="article:published_time"><meta data-vue-meta="ssr" name="image" property="og:image" content="https://www.market-scope.com/files/uploads/images/2026/04/i-Lumen%20Scientific%20logo.jpg" data-vmid="og:image"><meta data-vue-meta="ssr" name="author" content="Jennie Crabbe" data-vmid="author"><meta data-vue-meta="ssr" name="description" content="i-Lumen Scientific announced March 31 that the US FDA had signed off on its investigational device exemption (IDE) submission, allowing the company to procee..." data-vmid="description">
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All Rights reserved.</p></footer></div> <!----> <!----> <!----></div> <div id="invisible-recaptcha" data-sitekey="6LcfrXEUAAAAAL8oovQG9EMVvWYIrcgcHP2eWtjb" class="g-recaptcha g-recaptcha--left g-recaptcha--mobile-hidden g-recaptcha--desktop-hidden"></div> <!----></div><script>window.__INITIAL_STATE__={"companyNames":[],"articles":[],"article":{"id":9071,"position":355,"enabled":1,"draft":0,"author_uid":5164,"author_custom":"","title":"US FDA Gives Green Light to Trial of i-Lumen’s Bioelectric Stimulation Device for Dry AMD","slug_auto":"us-fda-gives-green-light-to-trial-of-i-lumen-s-bioelectric-stimulation-device-for-dry-amd","slug_override":null,"slug_history":null,"meta_title":null,"content":"\u003Chtml\u003E\u003Cbody\u003E\u003Cp style=\"text-align:center\"\u003E\u003Cimg alt=\"US FDA Gives Green Light to Trial of i-Lumen&rsquo;s Bioelectric Stimulation Device for Dry AMD\" height=\"69\" src=\"\u002Ffiles\u002Fuploads\u002Fimages\u002F2026\u002F04\u002Fi-Lumen%20Scientific%20logo.jpg\" width=\"400\" class=\"img-thumbnail \"\u003E\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003Ei-Lumen Scientific announced March 31 that the US FDA had signed off on its investigational device exemption (IDE) submission, allowing the company to proceed with a pivotal trial of its bioelectric stimulation therapy device for dry age-related macular degeneration (AMD).\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003Ei-Lumen, of Bloomington, Minnesota, said the i-SIGHT2 study is evaluating the effect of i-Lumen's AMD therapy on visual acuity in patients with intermediate to advanced dry AMD.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003Ei-SIGHT2 was already enrolling and treating patients in the UK, Australia, and New Zealand. The study will enroll 120 participants across all sites, with US enrollment expected to begin in late April 2026, i-Lumen said.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EAMD causes dysfunction of both photoreceptors and the retinal pigment epithelium (RPE). i-Lumen said its office-based, non-invasive bioelectric stimulation therapy, known as i-Lumen AMD, uses proprietary microcurrent stimulation to help improve RPE function and restore the electrophysiology of the retina.\u003C\u002Fp\u003E\r\n\u003C\u002Fbody\u003E\u003C\u002Fhtml\u003E\n","content_hub":null,"content_img_sources":["\u002Ffiles\u002Fuploads\u002Fimages\u002F2026\u002F04\u002Fi-Lumen%20Scientific%20logo.jpg"],"share_img_filename":null,"preview_img_blurhash":"LKQ9_@_3Rjt7RjRjayt7~qxuWBRj","preview_img_width":400,"preview_img_height":69,"meta_description":null,"allowed_roles":"24","inherit_specialty_descendents":1,"rules":[],"publish_date":"2026-04-10","qdrant_id":null,"entities":[{"text":"UK","type":"location"},{"text":"Australia","type":"location"},{"text":"New Zealand","type":"location"},{"text":"US FDA","type":"organization"},{"text":"visual acuity","type":"symptom"}],"landing_tags":[{"id":33,"namespace":null,"slug":"breaking","label":"Breaking","counter":5271,"created":"2018-09-26T07:21:07+00:00","modified":"2026-10-02T15:30:59+00:00","color":"#b50122"},{"id":100,"namespace":null,"slug":"clinical-trial","label":"Clinical Trial","counter":582,"created":"2019-08-09T16:44:56+00:00","modified":"2026-10-02T15:07:00+00:00","color":"#b75601"},{"id":36,"namespace":null,"slug":"device","label":"Device","counter":301,"created":"2018-09-26T16:31:41+00:00","modified":"2026-09-22T18:54:30+00:00","color":"#037f14"},{"id":105,"namespace":null,"slug":"regulation","label":"Regulation","counter":1362,"created":"2019-08-23T17:36:42+00:00","modified":"2026-10-02T15:21:14+00:00","color":"#0c8c0e"},{"id":89,"namespace":null,"slug":"retina","label":"Retina","counter":2179,"created":"2019-07-12T20:57:58+00:00","modified":"2026-10-02T15:16:48+00:00","color":"#06a325"}],"recommended_products":[{"id":593,"slug_override":null,"document_original_filename":"2026-Retina-Disease-Model-Cover.pdf","document_cover_filename":null,"document_sample_filename":null,"product_type":{"id":1,"slug":"ophthalmic-comprehensive-reports","name":"Ophthalmic Comprehensive Reports","attributes_separator":", ","pricing_models":[{"month_interval":0,"_joinData":{"id":1,"pricing_model_id":1,"product_type_id":1}}]},"product_type_attributes":[{"product_type_id":1,"attribute":"topic","_joinData":{"id":1443,"product_type_attribute_id":1,"product_id":593,"value":"2026 Retinal Disease Model"}},{"product_type_id":1,"attribute":"month","_joinData":{"id":1444,"product_type_attribute_id":2,"product_id":593,"value":"September"}},{"product_type_id":1,"attribute":"year","_joinData":{"id":1445,"product_type_attribute_id":3,"product_id":593,"value":"2026"}}],"tag_list":[],"label":"2026 Retinal Disease Model, September, 2026","slug":"2026-retinal-disease-model-september-2026"},{"id":556,"slug_override":null,"available":1,"document_original_filename":"Q4-2025-OMT-Retina-Final.pdf","document_sample_filename":null,"document_cover_filename":"Q4-2025 Retina Cover.jpg","_joinData":{"id":11910,"article_id":9071,"product_id":556,"created":"2026-04-10T15:36:11+00:00","modified":"2026-04-10T15:36:11+00:00"},"product_type":{"id":17,"slug":"ophthalmic-market-trends-us-retina-edition","name":"Ophthalmic Market Trends: US Retina Edition","attributes_separator":" - 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