Industry

i-Lumen Scientific Secures FDA IDE Approval to Launch US Phase of i-SIGHT2 AMD Study

Eyewire+2h ago2 min read

i-Lumen Scientific has received Investigational Device Exemption (IDE) approval from the FDA to begin enrollment in the United States for its i-SIGHT2 pivotal study. The clinical trial is evaluating the company’s noninvasive bioelectric stimulation therapy for patients with intermediate to advanced dry age-related macular degeneration (AMD). The FDA’s IDE approval enables i-Lumen to expand its ongoing global trial into the US. The i-SIGHT2 trial is already actively enrolling participants in the United Kingdom, Australia, and New Zealand. In total, the study aims to enroll 120 participants across all sites, with US enrollment expected to begin in late April 2026. “With the i-SIGHT2 study already enrolling participants across multiple international sites, receiving IDE approval from the FDA to expand into the United States represents an important step forward,” said John VeLure, CEO of i-Lumen Scientific. “The U.S. represents one of the largest populations of patients with intermediate to advanced dry AMD, and conducting the study reflects our commitment to providing physicians and patients with a noninvasive, office-based therapeutic approach.” The study has already achieved an early operational milestone, with the first participant successfully randomized and treated in the United Kingdom at London North West University Healthcare NHS Trust. The site is led by Christiana Dinah, Director of Research and Innovation. “Bioelectric stimulation therapy offers a genuinely novel mechanism to address RPE dysfunction in intermediate to advanced dry AMD,” said Professor Timothy Jackson, Global Principal Investigator for the i-SIGHT2 study at King’s College Hospital, London. “Expanding enrollment to the US further strengthens the study’s global reach and scientific rigor, and I look forward to the results of this study.” If the therapy demonstrates meaningful clinical benefit with an acceptable safety profile, the results could support future regulatory submissions for commercialization in the US and international markets.

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AI Summary

Quick Take

i-Lumen Scientific has received FDA Investigational Device Exemption (IDE) approval to launch the U.S. arm of its i-SIGHT2 pivotal trial, which evaluates a noninvasive bioelectric stimulation therapy for intermediate to advanced dry AMD. The study aims to enroll 120 participants globally to test a novel mechanism of action designed to address retinal pigment epithelium (RPE) dysfunction.

Why It Matters

As the industry moves beyond just slowing geographic atrophy (GA) with monthly injections, there is significant interest in noninvasive, office-based therapies that can be utilized earlier in the disease process. Bioelectric stimulation offers a completely different approach from current complement inhibitors, potentially providing a treatment option for patients who are injection-averse or in the intermediate stages of dry AMD. This study's expansion into the U.S. is a critical step toward validating whether electrical stimulation can meaningfully alter the course of RPE degeneration.

Key Details

The i-SIGHT2 trial evaluates a noninvasive bioelectric stimulation therapy targeting RPE dysfunction.
The FDA IDE approval allows the company to expand its ongoing international trial into the United States.
The study is currently enrolling participants in the United Kingdom, Australia, and New Zealand.
The first participant has already been randomized and treated at the London North West University Healthcare NHS Trust in the UK.
The therapy is designed as an office-based approach, potentially reducing the treatment burden compared to intravitreal injections.

Study Snapshot

Design

Pivotal clinical trial

Population

Patients with intermediate to advanced dry age-related macular degeneration (AMD)

Sample Size

120 participants

Who's Affected

Retina SpecialistsMedical OphthalmologistsOptometristsDry AMD Patients

What's Next

Enrollment for the U.S. phase of the i-SIGHT2 study is expected to begin in late April 2026. Results from the global 120-patient cohort will be used to support future regulatory submissions for commercialization in the U.S. and international markets.

Evidence StrengthPreliminary

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