Groundbreaking i-SIGHT2 Study Introduces Noninvasive Therapy for AMD Patients in the U.S.

i-Lumen Scientific Launches Pivotal Study in the U.S.

i-Lumen Scientific, a pioneering company in medical technology focusing on bioelectric therapies for retinal diseases, has announced a pivotal milestone in the fight against age-related macular degeneration (AMD). The first U.S. patient has been randomized in the i-SIGHT2 clinical trial, which evaluates the innovative i-Lumen AMD System designed for patients suffering from intermediate to advanced dry AMD.

The first study was conducted at Texas Retina Associates in Fort Worth, Texas—recognized as one of the nation’s foremost retina practices. This significant event follows the initiation of the pivotal study in the United Kingdom, thereby expanding i-Lumen's global clinical endeavors.

The i-SIGHT2 Study Overview

The i-SIGHT2 study is a randomized and sham-controlled trial aiming to assess the safety and efficacy of the i-Lumen AMD System—a noninvasive device designed for outpatient use. This system utilizes bioelectric therapy to enhance retinal electrophysiology and visual capabilities in patients experiencing vision loss due to advanced stages of dry AMD. The specific mechanism of the therapy involves low-level microcurrent stimulation delivered through the eyelid, which helps boost the transepithelial potential of the retinal pigment epithelium (RPE) cells, ultimately improving their function and the function of surrounding photoreceptor cells.

According to John VeLure, CEO of i-Lumen Scientific, “The randomization of the first U.S. patient in the i-SIGHT2 trial marks a significant advancement in our ongoing effort to provide new and effective treatment alternatives for those suffering from dry AMD.” He also expressed gratitude towards Texas Retina Associates for their continuous support during both the i-SIGHT feasibility study—completed the previous year—and the ongoing i-SIGHT2 trial.

The Urgency of Tackling AMD

AMD stands as one of the leading causes of severe vision impairment in adults over the age of 50, affecting approximately 230 million individuals globally. Strikingly, the number of patients afflicted with AMD is anticipated to surge in the next decade. An estimated 60% of these individuals are diagnosed with intermediate AMD, characterized by progressive central vision loss and limited treatment options as the condition advances.

The effects of AMD are particularly devastating, as the condition leads to functional impairments in the retinal pigment epithelium (RPE) and adjacent retinal cells located in the macula—the section of the retina responsible for focusing on central vision. As the disease progresses into its intermediate and advanced phases, patients often experience distortion in their central vision, which can significantly disrupt daily activities, including reading and driving.

Building on Prior Research

The i-SIGHT2 study is built upon the insights gained from i-Lumen's previous feasibility study, which explored the effects of bioelectric stimulation in patients grappling with vision loss caused by dry AMD. Results from that initial study showcased improvements in visual function and retinal health markers, thereby reinforcing the need for further investigation through a larger pivotal trial.

It is essential to note that the i-Lumen AMD System remains an investigational medical device and has yet to receive approval from the U.S. Food and Drug Administration (FDA) or other regulatory bodies for commercial utilization.

About i-Lumen Scientific

Founded to tackle cellular dysfunction related to retinal diseases, i-Lumen Scientific, Inc. is at the forefront of developing bioelectric therapies, harnessing bioelectric stimulation to revive retinal function and propose innovative treatment solutions for patients facing vision-threatening conditions, starting with age-related macular degeneration.

These forward-looking statements indicate an essential progression in AMD treatment technologies, revealing a hopeful future for countless patients on the verge of debilitating vision loss. As clinical trials continue, the medical community remains optimistic about the potential benefits of bioelectric therapy and its role in restoring sight to those who need it most.