Milestone initiates U.S. participation in pivotal clinical trial of the i-Lumen AMD System for patients with intermediate to advanced dry age-related macular degeneration
BLOOMINGTON, Minn., July 21, 2026 /PRNewswire/ -- i-Lumen Scientific, Inc., a clinical-stage medical technology company developing bioelectric therapies for retinal disease, today announced the first U.S. patient has been randomized in the i-SIGHT2 pivotal study evaluating the i-Lumen AMD System in patients with intermediate to advanced dry age-related macular degeneration (AMD).
The first U.S. i-SIGHT2 study randomization occurred at Texas Retina Associates, Fort Worth, TX, one of the nation's leading retina practices. The milestone follows the initiation of the pivotal study in the United Kingdom and represents an important step in advancing i-Lumen's global clinical program.
i-SIGHT2 is a randomized, sham-controlled study designed to evaluate the safety and effectiveness of the i-Lumen AMD System, an investigational device that delivers a noninvasive, office-based bioelectric therapy intended to improve retinal electrophysiology and visual function in patients with vision loss due to intermediate to advanced dry AMD. The therapy delivers low-level microcurrent stimulation through the eyelid to boost the transepithelial potential, repolarizing the retinal pigment epithelium (RPE) cells to improve photoreceptor cell function.
"Randomizing the first U.S. patient in i-SIGHT2 is an important milestone for i-Lumen and for the broader effort to develop meaningful new treatment options for patients with dry AMD," said John VeLure, CEO and President at i-Lumen Scientific. "We are grateful to Texas Retina Associates for their continued partnership and participation in both the i-SIGHT feasibility study that was completed last year and the i-SIGHT2 pivotal study. The i-SIGHT2 pivotal trial is designed to evaluate the benefits of bioelectric therapy in restoring retinal electrophysiology and signaling to improve visual outcomes in a patient population with significant unmet need."
AMD is a leading cause of vision loss worldwide in adults over age 50, affecting more than 230 million people globally, with prevalence expected to rise significantly over the next decade. More than 60% of these patients have intermediate AMD, a stage marked by progressive central vision loss and limited treatment options before the disease advances further.
AMD results in vision loss due to the dysfunction of the retinal pigment epithelium (RPE) and other retinal cells within the macula-the part of the retina that is responsible for central vision. In the intermediate to advanced dry stages, central vision becomes distorted and progression of the disease leads to significant vision loss, making daily activities difficult, such as reading, driving and face recognition.
The i-SIGHT2 study builds on findings from i-Lumen's prior i-SIGHT feasibility study, which evaluated bioelectric stimulation in patients with vision loss due to intermediate to advanced dry AMD. In that study, treated eyes demonstrated improvements in visual function, retinal electrophysiology, and structural biomarkers associated with photoreceptor health, supporting continued evaluation in a larger pivotal trial.
The i-Lumen AMD System is an investigational medical device and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for commercial use.
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. The proposed mechanism boosts transepithelial potential, repolarizing the retinal pigment epithelium (RPE) to improve retinal homeostasis, photoreceptor function, and visual acuity. 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 bioelectric stimulation to restore retinal function, 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
View original content to download multimedia:https://www.prnewswire.co.uk/news-releases/i-lumen-scientific-announces-first-us-patient-randomized-in-i-sight2-pivotal-study-evaluating-noninvasive-bioelectric-therapy-for-intermediate-to-advanced-dry-amd-302830842.html
