i-Lumen Scientific Advances in Treatment for Dry AMD with FDA Approval to Commence U.S. Enrollment

i-Lumen Scientific Gains FDA Approval for i-SIGHT2 Clinical Trial in the U.S.

i-Lumen Scientific, Inc., renowned for its groundbreaking innovations in ophthalmology, has reached a pivotal point in its endeavor to revolutionize treatment options for patients suffering from intermediate to advanced dry age-related macular degeneration (AMD). Recently, the Food and Drug Administration (FDA) granted the company an Investigational Device Exemption (IDE) to kick-start enrollment for U.S. participants in the i-SIGHT2 pivotal study. This milestone opens the door for advanced therapies that may greatly enhance the visual experience for individuals grappling with vision loss due to dry AMD.

The i-SIGHT2 study aims to scrutinize the efficacy of i-Lumen's non-invasive bioelectric stimulation therapy on improving visual acuity among patients affected by this debilitating condition. As it stands, the trial is already in motion with active enrollment processes taking place in the United Kingdom, Australia, and New Zealand. A total of 120 participants are expected across all sites, with the U.S. enrollment slated to commence in late April 2026.

John VeLure, CEO of i-Lumen Scientific, expressed enthusiasm considering the implications of the FDA's approval: "With the i-SIGHT2 study already enrolling participants globally, receiving IDE approval signifies a major advancement in expanding this crucial trial to the United States, where a significant number of patients reside."

In the United Kingdom, a pivotal step was also completed with the first participant being randomized and successfully treated at London North West University Healthcare NHS Trust, under the careful supervision of Ms. Christiana Dinah, Director of Research and Innovation. Dinah remarked, "AMD patients with vision impairment often face limited treatment options. i-Lumen's approach, characterized by its non-invasive nature, presents a compelling avenue for research in this field."

AMD is a leading contributor to vision loss worldwide, particularly affecting individuals over the age of 50. Presently, over 230 million people worldwide live with AMD, and projected estimates suggest an alarming rise in this number over the coming decade. Those grappling with intermediate to advanced forms of dry AMD typically experience a progressive decline in central vision and face substantial challenges in their daily lives, such as reading, driving, and even recognizing faces.

This degeneration is chiefly attributed to the malfunctioning of specific retinal cells within the macula—the key area of the retina responsible for central vision. In advanced cases of dry AMD, patients confront distorted central vision as the disease advances, ultimately leading to severe visual impairment.

The intricate workings of the retina’s electrophysiology can be significantly disrupted by AMD, resulting in the deterioration of both photoreceptors and the retinal pigment epithelium (RPE)—the essential cell layer that sustains photoreceptor health and overall retinal function. i-Lumen's innovative bioelectric stimulation therapy leverages proprietary microcurrent stimulation aimed at enhancing RPE functionality and the retina's electrophysiological balance.

Professor Timothy Jackson, the global principal investigator for the i-SIGHT2 study based at King's College Hospital in London, conveyed optimism regarding the study's implications: "Bioelectric stimulation therapy presents a unique approach to combat RPE dysfunction associated with intermediate to advanced dry AMD. The initiation of U.S. enrollment elevates the study's global reach and scientific validity, and I eagerly await the findings."

The i-SIGHT2 Study is poised to supply critical insights about the impact of i-Lumen's AMD therapy on visual acuity among patients suffering from intermediate to advanced dry AMD. Should the research yield significant improvements in visual capacity while maintaining a safe profile, it could pave the way for regulatory submissions that may enable commercial availability in both U.S. and international markets.

As scientists and practitioners follow the trial's progression, the hope for innovative, effective treatment solutions for AMD patients is steadily rising.

Media Contact

Geoff Bremner
Investor Relations
i-Lumen Scientific, Inc.
Phone: +1 (833) 938-2020
Email: [email protected]

About i-Lumen Scientific, Inc.

Founded at the forefront of biomedical innovation, i-Lumen Scientific, Inc. specializes in non-invasive therapies utilizing bioelectric stimulation aimed at treating intermediate to advanced dry age-related macular degeneration (AMD). Their patented i-Lumen AMD™ System targets retinal stimulation to enhance RPE functionality and promote photoreceptor health, ultimately seeking to improve visual acuity and retinal electroactivity for millions suffering from dry AMD. The i-Lumen AMD System represents an innovative, office-based treatment option for those in dire need, currently under clinical evaluation in the i-SIGHT2 Study. For more information, visit www.i-lumen.com.