Bioelectric Therapy Enters Pivotal Trial for Dry AMD, suggests study

A pivotal trial is underway evaluating i-Lumen AMD, a noninvasive, office-based bioelectric therapy for intermediate to advanced dry age-related macular degeneration (AMD). The treatment uses low-level microcurrent stimulation applied to the eyelid and is being investigated for its potential to slow or improve disease progression. Further clinical data are needed to establish its safety and effectiveness.

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.