i-Lumen Scientific enrolls first U.S. patient in dry AMD pivotal trial

i-Lumen Scientific has randomized the first U.S. patient in its i-SIGHT2 pivotal study of the i-Lumen AMD System, a noninvasive bioelectric therapy for intermediate to advanced dry age-related macular degeneration. The milestone expands the company’s clinical program beyond the United Kingdom as it tests whether the investigational device can improve retinal function and vision.

Why it matters: - Dry age-related macular degeneration is a leading cause of vision loss in adults over 50. - The condition affects more than 230 million people worldwide. - More than 60% of AMD patients have the intermediate stage, where treatment options are limited before the disease worsens. - The i-SIGHT2 trial is designed to test whether bioelectric therapy can improve retinal function and visual outcomes in a patient group with significant unmet need.

What happened: - i-Lumen Scientific said the first U.S. patient was randomized in the i-SIGHT2 pivotal study. - The randomization took place at Texas Retina Associates in Fort Worth, Texas. - Texas Retina Associates is one of the nation’s leading retina practices, according to i-Lumen Scientific. - The U.S. milestone follows the start of the pivotal study in the United Kingdom. - i-Lumen Scientific is a clinical-stage medical technology company developing bioelectric therapies for retinal disease.

The details: - i-SIGHT2 is a randomized, sham-controlled study evaluating the safety and effectiveness of the i-Lumen AMD System. - The device is investigational and is intended for patients with vision loss due to intermediate to advanced dry AMD. - The therapy delivers low-level microcurrent stimulation through the eyelid. - The stated goal is to boost transepithelial potential and repolarize retinal pigment epithelium cells. - The company says the mechanism is designed to improve photoreceptor cell function. - The i-Lumen AMD System is intended to improve retinal electrophysiology and visual function. - In the prior i-SIGHT feasibility study, treated eyes showed improvements in visual function, retinal electrophysiology and structural biomarkers associated with photoreceptor health. - i-Lumen Scientific said those findings supported a larger pivotal trial. - The i-Lumen AMD System has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for commercial use.

Between the lines: - The first U.S. randomization signals that i-Lumen Scientific is moving from feasibility work into a broader test of its lead therapy. - The trial’s sham control and pivotal design suggest the company is trying to generate data that could matter for future regulatory review. - The company is positioning bioelectric stimulation as a potential option for a disease stage with few established treatments. - Vision loss from AMD can distort central vision and make reading, driving and face recognition difficult.

What's next: - i-SIGHT2 will continue enrolling and evaluating patients in the U.S. and the U.K. - The study will assess safety and effectiveness outcomes for the investigational system. - i-Lumen Scientific said the trial is intended to further test whether bioelectric therapy can restore retinal electrophysiology and signaling. - Any path to commercial use remains dependent on additional clinical and regulatory steps.

The bottom line: - i-Lumen Scientific has reached an early but important U.S. milestone for its lead dry AMD program, and the next phase is proving the therapy works in a larger pivotal study.