i-Lumen Scientific Receives FDA IDE Approval to Expand Bioelectric Stimulation Trial for Dry AMD to U.S.
核心洞察
i-Lumen Scientific (搜索) received FDA Investigational Device Exemption approval to initiate U.S. enrollment in the i-SIGHT2 pivotal study evaluating bioelectric stimulation therapy (搜索) for intermediate to advanced dry AMD (搜索).
The global trial will enroll 120 participants across multiple countries, with the first patient already treated in the United Kingdom and U.S. enrollment expected to begin in late April 2026.
The non-invasive therapy uses proprietary microcurrent stimulation delivered via electrodes to improve retinal pigment epithelium (搜索) function and address underlying dry AMD (搜索) pathology.
i-Lumen Scientific (搜索) announced it has received Investigational Device Exemption (IDE) approval from the FDA to initiate U.S. enrollment in the i-SIGHT2 pivotal study, marking a significant expansion of the global trial evaluating bioelectric stimulation therapy (搜索) for intermediate to advanced dry age-related macular degeneration (搜索) (AMD (搜索)). The approval allows the company to begin treating American patients with its non-invasive therapy, with enrollment anticipated to start in late April 2026.
Global Trial Reaches Key Operational Milestone
The i-SIGHT2 study is already actively enrolling and treating participants in the United Kingdom, Australia, and New Zealand, with the first participant successfully randomized and treated at London North West University Healthcare NHS Trust under the leadership of Christiana Dinah, Director of Research and Innovation. "This population of AMD (搜索) 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," Dinah stated.
The multicenter, randomized, sham-controlled, double-masked clinical device trial will enroll an estimated 120 dry AMD (搜索) patients aged 60 and older across all international sites. Participants will undergo an initial loading regimen followed by seven maintenance sessions over an 11-month period, then return monthly through month 14 for evaluation and monitoring.
Novel Bioelectric Approach Targets Retinal Dysfunction
i-Lumen's bioelectric stimulation therapy (搜索) represents a fundamentally different approach to treating dry AMD (搜索) compared to current pharmaceutical interventions. The i-Lumen AMD System (搜索) delivers proprietary pulsed microcurrent stimulation to the retina via electrodes placed on the eyelid and neck, directing current to the retina without requiring implants or invasive procedures.
The therapy targets retinal pigment epithelium (搜索) (RPE (搜索)) dysfunction, a critical component of AMD (搜索) pathology. "Bioelectric stimulation therapy (搜索) 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," said Professor Timothy Jackson, Global Principal Investigator for the i-SIGHT2 study at King's College Hospital, London.
The system includes proprietary software with preset treatment algorithms calibrated to each patient, designed to restore normal function of RPE (搜索) and Müller cells (搜索) and restart neural pathways to treat dry AMD (搜索). These cells play critically supportive roles for the retina's photoreceptors (搜索), which process light and send visual information to the brain.
Promising Early Clinical Results Support Pivotal Trial
The clinical program began in 2022 with the U.S.-based iSIGHT feasibility study, which evaluated 30 dry AMD (搜索) patients in a randomized, sham-controlled trial over 12 months. Patients underwent a five-day treatment regimen followed by two maintenance treatments at months one and two. At the three-month mark, over 50% of treated patients achieved an improvement in best-corrected visual acuity of two or more lines from baseline.
The i-SIGHT2 study's primary outcome measure is the mean change in best-corrected visual acuity from baseline at month three, measured on the Early Treatment Diabetic Retinopathy Scale visual acuity chart comparing active treatment versus sham. Secondary endpoints include the portion of per-eye responders showing at least 10-letter improvement and mean change in visual acuity at month six.
Addressing Significant Unmet Medical Need
AMD (搜索) affects more than 230 million people globally and is a leading cause of vision loss in adults over 50, with prevalence expected to rise significantly over the next decade. Patients with intermediate to advanced dry AMD experience progressive central vision loss that makes daily activities like reading, driving, and face recognition difficult.
"The U.S. represents one of the largest populations of patients with intermediate to advanced dry AMD (搜索), and conducting the study reflects our commitment to providing physicians and patients with a non-invasive, office-based therapeutic approach," said John VeLure, Chief Executive Officer of i-Lumen Scientific (搜索).
The retina's complex electrophysiology is affected by AMD (搜索), causing dysfunction of both photoreceptors (搜索) and the RPE (搜索) layer responsible for maintaining photoreceptor health and retinal function. Current treatment options for this patient population remain limited, creating substantial unmet medical need.
Regulatory Path Forward
If the i-SIGHT2 study demonstrates meaningful improvement in visual function with an acceptable safety profile, the results could support regulatory submission for commercialization in the U.S. and international markets. Jackson noted that expanding enrollment to the U.S. "further strengthens the study's global reach and scientific rigor."
The company's technology is reportedly patented in the United States, Australia, Canada, and the European Union, positioning i-Lumen Scientific (搜索) to potentially commercialize the therapy across major markets pending successful trial outcomes and regulatory approvals.