i-Lumen Scientific has randomised the first U.S. patient in the i-SIGHT2 pivotal study of its i-Lumen AMD System for intermediate to advanced dry age-related macular degeneration.

The first U.S. randomisation took place at Texas Retina Associates in Fort Worth. The milestone follows initiation of the pivotal study in the United Kingdom and expands the company’s global clinical programme.

The i-SIGHT2 study is a randomised, sham-controlled trial evaluating the safety and effectiveness of the i-Lumen AMD System. The investigational device delivers 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. It is designed to boost the transepithelial potential and repolarise retinal pigment epithelium cells, supporting photoreceptor cell function.

This is relevant because dry AMD remains a major cause of progressive vision loss in older adults. The company noted that AMD affects more than 230 million people globally, with more than 60 per cent of patients in the intermediate stage, where treatment options remain limited before progression to more advanced disease.

The i-SIGHT2 pivotal trial will assess whether noninvasive bioelectric therapy can improve visual outcomes in a patient group with substantial unmet need. The study builds on earlier feasibility work and brings the system into a broader pivotal evaluation across international clinical sites.