#USA #Bloomington #AMD #i-Lumen #Bioelectric Therapy

i-Lumen's i-SIGHT Feasibility Study Results Presented at CTS Retina 2026

On November 10, 2026, i-Lumen Scientific, a company focused on medical technology specifically for retinal diseases, unveiled noteworthy findings from their i-SIGHT feasibility study during the Clinical Trials at the Summit Retina meeting. This multicenter study was pivotal in evaluating the i-Lumen AMD System, which aims to provide therapeutic options for patients suffering from age-related macular degeneration (AMD).

The i-SIGHT study targeted individuals with intermediate to advanced stages of nonexudative (dry) AMD. In total, 30 participants were enrolled across 10 retina centers in the United States. The primary goals of the study were to assess the device's safety, improvements in visual function, retinal electrophysiology, and various structural biomarkers. Participants first underwent an intensive 5-day treatment course, followed by assessments at the 1 and 2-month marks, continuing through to the 12-month follow-up.

Insights from the Study

The i-Lumen AMD System employs a unique noninvasive bioelectric therapy that utilizes low-level microcurrent stimulation delivered through the eyelid. This method aims to enhance the retina's bioelectrical signaling, potentially restoring vital functions. It is believed that this therapy may help to reinstate the retinal pigment epithelium's transepithelial electrical potential, thus supporting retinal stability and photoreceptor activity.

Dr. Sophie J. Bakri, Professor and Chair of Ophthalmology at the Mayo Clinic, presented the study's findings, highlighting significant improvements in participants' visual acuity. The average improvement from baseline in the actively treated eye was +9.62 ETDRS letters by Month 3. In comparative analyses, the active eyes outperformed untreated fellow eyes by +8.54 ETDRS letters and showcased a +3.9 ETDRS letter advantage over the sham group.

In addition, more than half of the participants experienced at least a 10-letter improvement in best-corrected visual acuity at one or more follow-up visits during the 12-month period. Exploratory analyses using Optical Coherence Tomography (OCT) had demonstrated significant improvements in ellipsoid zone integrity, peaking at a 47.6% enhancement by week three, and maintaining a 39% improvement by Month 3.

Notably, the study reported no unexpected device-related adverse events, maintaining comparable adverse event rates among the treatment and sham groups, which lends credibility to the findings.

Implications for Future Research

Dr. Bakri expressed optimism regarding these findings, suggesting they indicate that retinal bioelectric stimulation may positively affect visual function for those experiencing dry AMD. While the study was designed as a feasibility trial rather than a definitive efficacy test, these encouraging signals in terms of visual gains, retinal electrophysiological measurements, and imaging biomarkers paves the way for further research.

i-Lumen's CEO, John VeLure, echoed this sentiment by acknowledging the study's contribution as a critical milestone towards innovative treatments for patients with dry AMD, a demographic currently presenting considerable unmet medical needs. To expand on these results, the company has launched the larger i-SIGHT2 pivotal clinical trial, which is now enrolling participants in the U.S. and the U.K.

About i-Lumen Scientific

i-Lumen Scientific focuses on developing bioelectric therapies to combat cellular dysfunction linked to retinal diseases. By utilizing targeted microcurrent stimulation, they aim to restore physiological electrical signaling within the retina, aspiring to create new therapeutic solutions beginning with AMD.

As these promising studies unfold, the potential impact on the quality of life for patients with AMD could be profound, illustrating a hopeful direction in retinal disease management.

Note: The i-Lumen AMD System is an investigational device and has yet to gain approval for commercial use from regulatory authorities.