i-Lumen Scientific Achieves FDA Approval to Begin U.S. Enrollment in Pivotal i-SIGHT2 Clinical Study Targeting Dry AMD

i-Lumen Scientific Makes Major Leap in AMD Treatment

In a groundbreaking development for the field of ophthalmology, i-Lumen Scientific, Inc. has secured FDA approval to initiate enrollment in the United States for its i-SIGHT2 pivotal clinical study. This trial focuses on a non-invasive bioelectric stimulation therapy targeting intermediate to advanced dry age-related macular degeneration (AMD), a leading cause of vision loss worldwide.

Understanding Dry AMD

Dry AMD is a progressive eye disorder that predominantly affects individuals aged over 50. More than 230 million people globally grapple with this condition, and the prevalence is projected to surge over the next decade. This condition leads to a slow but steady deterioration of the macula, a critical area of the retina responsible for central vision. Patients in the intermediate to advanced stages of dry AMD often experience significant visual impairment, complicating daily activities such as reading or driving. With limited treatment options available, many patients find themselves with few promising alternatives.

The i-SIGHT2 Clinical Study

The i-SIGHT2 clinical study has been actively enrolling participants across various international sites, including the United Kingdom, Australia, and New Zealand, prior to its expansion into the United States. The FDA's Investigational Device Exemption (IDE) approval represents a crucial milestone not only for i-Lumen Scientific but also for the AMD community, as it opens avenues for new treatments that could significantly enhance the quality of life for patients.

The study aims to include 120 participants, with U.S. enrollment slated to kick off in late April 2026. John VeLure, CEO of i-Lumen Scientific, emphasized the importance of this expansion, stating that the U.S. hosts one of the largest segments of patients afflicted by the condition.

The non-invasive nature of i-Lumen's therapy, which operates through microcurrent stimulation, is notable for offering an accessible treatment option for many users. This therapy aims to restore the health of photoreceptors and the retinal pigment epithelium (RPE), thus enhancing overall retinal function and potentially improving visual acuity.

WHO and Research Community's Perspective

In line with the FDA's approval, the first participant in the i-SIGHT2 study has successfully been randomized and treated in the UK at London North West University Healthcare NHS Trust. Ms. Christiana Dinah, Director of Research and Innovation, expressed her enthusiasm for this study, noting the compelling need for innovative solutions in a population with limited options.

Professor Timothy Jackson, Global Principal Investigator at King's College Hospital, London, remarked, "Bioelectric stimulation therapy presents a novel mechanism to address RPE dysfunction in advanced dry AMD. The expansion into the U.S. signals a strengthened global collaboration aimed at rigorously assessing this new therapy's effectiveness.”

Implications for Future Treatment

The i-SIGHT2 study will provide valuable evidence on whether i-Lumen's non-invasive therapy can result in meaningful improvements in visual function for patients suffering from intermediate to advanced dry AMD. Demonstrating a positive shift in visual acuity coupled with an established safety profile could pave the way for regulatory submission for commercialization within the U.S. and abroad.

As this trial progresses, both investigators and clinicians remain keenly interested in monitoring advancements across all sites, as they hold the potential to change the landscape of treatment options available for millions facing the daunting challenges posed by AMD.

For more information about this innovative therapy and updates on the clinical trial, visit i-Lumen Scientific.