i-Lumen Scientific Receives FDA Approval to Expand Dry AMD Clinical Trial to U.S.

The i-SIGHT2 study is evaluating a non-invasive bioelectric stimulation therapy for intermediate to advanced dry age-related macular degeneration.

Mar. 31, 2026 at 5:30pm

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A translucent X-ray photograph showing the delicate internal structure of the human retina, with glowing lines and shapes representing the complex electrophysiology affected by dry age-related macular degeneration.A novel bioelectric stimulation therapy aims to address the underlying retinal dysfunction caused by advanced dry macular degeneration.Bloomington Today

i-Lumen Scientific, Inc., a leader in energy-based innovations for ophthalmology, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) to initiate enrollment in the U.S. for the i-SIGHT2 Pivotal Study, which is evaluating the company's non-invasive bioelectric stimulation therapy for the treatment of intermediate to advanced dry age-related macular degeneration (AMD). The study is already actively enrolling and treating participants in the United Kingdom, Australia, and New Zealand.

Why it matters

Dry AMD is a leading cause of vision loss worldwide, affecting more than 230 million people globally, with prevalence expected to rise significantly over the next 10 years. Patients with intermediate to advanced dry AMD have very limited treatment options, making this a critical area of investigation for new non-invasive therapies.

The details

The i-SIGHT2 study will enroll 120 participants across all sites, with U.S. enrollment anticipated to begin in late April 2026. The study is evaluating the effect of i-Lumen's AMD therapy on visual acuity in patients with vision loss due to intermediate to advanced dry AMD. The therapy uses proprietary microcurrent stimulation to help improve retinal pigment epithelium (RPE) function and the electrophysiology of the retina, which are affected by AMD.

  • The first participant was successfully randomized and treated in the United Kingdom at London North West University Healthcare NHS Trust in March 2026.
  • U.S. enrollment in the i-SIGHT2 study is anticipated to begin in late April 2026.

The players

i-Lumen Scientific, Inc.

A leader in non-invasive, bioelectric stimulation therapy innovations in Ophthalmology for the treatment of intermediate to advanced dry age-related macular degeneration (AMD).

John VeLure

Chief Executive Officer of i-Lumen Scientific, Inc.

Christiana Dinah

Director of Research and Innovation at London North West University Healthcare NHS Trust, where the first participant in the i-SIGHT2 study was treated.

Timothy Jackson

Global Principal Investigator for the i-SIGHT2 study at King's College Hospital, London.

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What they’re saying

“With the i-SIGHT2 study already enrolling study participants across multiple international sites, receiving IDE approval from the FDA to expand into the United States represents an important step forward.”

— John VeLure, Chief Executive Officer of i-Lumen Scientific, Inc.

“This population of AMD patients with vision loss has very limited options, and the non-invasive nature of i-Lumen's approach makes it a particularly compelling area of investigation.”

— Christiana Dinah, Director of Research and Innovation at London North West University Healthcare NHS Trust

“Bioelectric stimulation therapy offers a genuinely novel mechanism to address RPE dysfunction in intermediate to advanced dry AMD, and the i-SIGHT2 study is an important next step in evaluating its effectiveness.”

— Timothy Jackson, Global Principal Investigator for the i-SIGHT2 study at King's College Hospital, London

What’s next

The i-SIGHT2 Study will provide important evidence regarding the effect of the i-Lumen AMD therapy on visual acuity for intermediate to advanced dry AMD patients with vision loss. If the study demonstrates a meaningful change in visual function, with an acceptable safety profile, it could support regulatory submission for commercialization in the U.S. and international markets.

The takeaway

The expansion of the i-SIGHT2 clinical trial to the United States represents a significant milestone in the development of a novel, non-invasive therapy for the millions of people suffering from intermediate to advanced dry age-related macular degeneration, a leading cause of vision loss worldwide with limited treatment options.