i-Lumen Scientific enrolls first US patient in i-SIGHT2 pivotal trial of i-Lumen AMD System

i-Lumen Scientific, Inc announced that the first US patient has been randomly assigned in the i-SIGHT2 pivotal study (NCT06662162) evaluating the i-Lumen AMD System in patients with intermediate to advanced dry age-related macular degeneration (AMD). According to a news release, the company is a clinical-stage medical technology company developing bioelectric therapies for retinal disease.

The first US randomization occurred at Texas Retina Associates in Fort Worth, Texas. The milestone follows the initiation of the pivotal study in the UK and represents a step toward 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 delivering a noninvasive, office-based bioelectric therapy. The therapy is intended to improve retinal electrophysiology and visual function in patients with vision loss from intermediate- to advanced-stage dry AMD. It delivers low-level microcurrent stimulation through the eyelid to increase transepithelial potential, repolarizing retinal pigment epithelium (RPE) cells and improving photoreceptor cell function. The study builds on findings from the prior i-SIGHT feasibility study, which evaluated bioelectric stimulation in the same patient population. In the feasibility study, treated eyes showed improvements in visual function, retinal electrophysiology, and structural biomarkers of photoreceptor health, according to the announcement.¹

What i-SIGHT feasibility findings mean for the i-Lumen AMD System pivotal program

The feasibility study results supported continued evaluation in a larger pivotal trial. AMD affects more than 230 million people globally over the age of 50 years, with prevalence expected to rise over the next decade, according to the company. More than 60% of these patients have intermediate AMD, a stage marked by progressive central vision loss and limited treatment options before further disease advancement. The i-Lumen AMD System is an investigational medical device and has not been approved by the US Food and Drug Administration or any other regulatory authority for commercial use.

“[Randomly assigning] the first US 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, in the release.¹ “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.”

The i-Lumen AMD System is investigational and is not available for clinical use. The therapy is described as noninvasive and office-based. Optometrists monitoring these patients may encounter the device in the context of ongoing pivotal trial enrollment.¹

Reference

1. i-Lumen Scientific announces first US patient randomized in i-SIGHT2 pivotal study evaluating noninvasive bioelectric therapy for intermediate to advanced dry AMD. News release. i-Lumen Scientific, Inc. July 21, 2026. Accessed July 21, 2026. https://www.prnewswire.com/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-302830823.html