Randomized, sham-controlled feasibility trial of noninvasive bioelectric identified signals of potential improvement in visual function, retinal electrophysiology, and structural biomarkers in dry AMD

BLOOMINGTON, Minn., Nov. 10, 2026 /PRNewswire/ — i-Lumen Scientific, Inc., a clinical-stage medical technology company developing bioelectric therapies for retinal disease, announced clinical findings from its i-SIGHT feasibility study following the presentation at the 2026 Clinical Trials at the Summit Retina meeting.

The i-SIGHT study was a multicenter, randomized, sham-controlled feasibility medical device trial evaluating the i-Lumen AMD System in patients with vision loss due to intermediate to advanced nonexudative (dry) age-related macular degeneration (AMD). The study enrolled 30 participants across 10 U.S. retina centers and assessed safety, visual function, retinal electrophysiology, and retinal structural biomarkers.  Participants completed an initial 5-day treatment regimen, and two 1-day treatment visits at Months 1 and 2, and were followed out to the Month 12 time point.

The i-Lumen AMD System is an investigational medical device that delivers noninvasive bioelectric therapy via low-level microcurrent stimulation through the eyelid. The therapy is intended to influence retinal bioelectrical signaling. Proposed mechanisms include restoration of the retinal pigment epithelium’s (RPE) transepithelial electrical potential (TEP), which may support retinal homeostasis and photoreceptor function.

Results were presented by Sophie J. Bakri, MD, MBA, Professor and Chair of Ophthalmology at Mayo Clinic. Watch the “First Time Results of Clinical Trials” recorded session here.  

Key findings from the study include:

• The mean change from baseline for the active study eye was +9.62 EDTRS letters at Month 3. In exploratory analyses, active study eyes demonstrated an +8.54 ETDRS-letter advantage relative to untreated fellow eyes at Month 3 and a +3.9 ETDRS-letter advantage when compared to sham.
• Improvements in photoreceptor response time, as measured by multifocal electroretinography (mfERG), were associated with improvements in visual acuity.
• More than 50% of treated participants achieved a ≥10-letter improvement in best-corrected visual acuity (BCVA) at one or more follow-up visits between Months 2 and 12.
• Exploratory OCT analyses demonstrated improvement in ellipsoid zone integrity during the treatment period, with a maximum observed improvement of 47.6% by week 2 with a sustained improvement of 39% by Month 3.
• No unanticipated device-related adverse events were reported, and overall adverse event rates were comparable between the active and sham groups.

“These findings from a feasibility study suggest that retinal bioelectric stimulation may influence visual function in patients with intermediate to advanced dry AMD,” said Dr. Bakri. “While the study was not designed to establish definitive efficacy, the signals observed in visual acuity, retinal electrophysiology, and imaging biomarkers support further evaluation in larger controlled clinical trials.”

AMD remains a leading cause of irreversible vision loss worldwide. While recent therapeutic advances have emerged for geographic atrophy, significant unmet need remains for treatments that address retinal dysfunction earlier in the disease process and improve visual outcomes for patients with intermediate to advanced dry AMD.

“This data represents an important milestone in the pursuit of new treatment options for patients with intermediate to advanced dry AMD, a population with significant unmet need,” said John VeLure, CEO of i-Lumen Scientific. “The i-SIGHT findings add to the growing body of evidence supporting bioelectric stimulation as a novel therapeutic approach for these patients.”

i-Lumen has initiated a larger pivotal clinical trial, the i-SIGHT2 Study, and is currently enrolling in the US and the UK.

About the i-Lumen AMD System

The i-Lumen AMD System is an investigational medical device designed to deliver low-level microcurrent stimulation through the eyelid to improve retinal electrophysiology. Proposed mechanisms include restoration of the retinal pigment epithelium’s (RPE) transepithelial electrical potential (TEP), which may support retinal homeostasis and photoreceptor function. The device is currently under clinical investigation and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for commercial use.

About i-Lumen Scientific

i-Lumen Scientific, Inc. is developing bioelectric therapies designed to address cellular dysfunction associated with retinal disease. By leveraging targeted microcurrent stimulation to restore physiological electrical signaling within the retina, the company aims to develop novel treatment options for patients with vision-threatening diseases, beginning with age-related macular degeneration.

Forward-Looking Statements

This press release contains forward-looking statements regarding the development, clinical performance, potential benefits, regulatory pathway, and future prospects of the i-Lumen AMD System. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Results from feasibility studies may not be predictive of outcomes in larger clinical trials. The i-Lumen AMD System is an investigational device and has not been approved for commercial use. i-Lumen undertakes no obligation to update forward-looking statements except as required by law.

Media Contact

Contact:
Geoff Bremner
Investor Relations
i-Lumen Scientific, Inc.
Phone: +1 (833) 938-2020
Email: pr@i-lumen.com

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SOURCE i-LUMEN SCIENTIFIC, Inc.