Key Takeaways

  • The first US patient has been randomized in the sham-controlled i-SIGHT2 pivotal trial evaluating the investigational i-Lumen AMD System for intermediate to advanced dry AMD
  • The office-based therapy delivers low-level microcurrent stimulation through the eyelid with the goal of restoring retinal electrophysiology and improving visual function

i-Lumen Scientific announced that the first US patient has been randomized in the i-SIGHT2 pivotal clinical trial evaluating the investigational i-Lumen AMD System for patients with intermediate to advanced dry age-related macular degeneration (AMD).

The first US randomization took place at Texas Retina Associates in Fort Worth, Texas, following the study's earlier launch in the United Kingdom. According to the company, the milestone marks the expansion of its global clinical development program for the investigational device.

The i-SIGHT2 trial is a randomized, sham-controlled study designed to evaluate the safety and effectiveness of the i-Lumen AMD System, a noninvasive, office-based bioelectric therapy intended to improve retinal electrophysiology and visual function in patients with vision loss caused by intermediate to advanced dry AMD.

The investigational therapy delivers low-level microcurrent stimulation through the eyelid to increase the transepithelial potential and repolarize retinal pigment epithelium (RPE) cells. The company said the approach is intended to improve photoreceptor cell function by restoring retinal electrophysiologic signaling.

"Randomizing 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 of 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."

Mr. VeLure added that the pivotal trial is designed to evaluate whether bioelectric therapy can restore retinal electrophysiology and signaling to improve visual outcomes in a patient population with significant unmet need.

The pivotal study builds on results from the company's earlier i-SIGHT feasibility study, in which treated eyes demonstrated improvements in visual function, retinal electrophysiology, and structural biomarkers associated with photoreceptor health. Those findings supported advancement to the larger pivotal trial.