IDE approval by the FDA marks a significant milestone in the global expansion of the i-SIGHT2 study, which is already actively enrolling and treating study participants in the United Kingdom, Australia, and New Zealand. The study will enroll 120 participants across all sites, with U.S. enrollment anticipated to begin in late April 2026.
"With the i-SIGHT2 study already enrolling study participants across multiple international sites, receiving IDE approval from the FDA to expand into the United States. represents an important step forward," said John VeLure, Chief Executive Officer of i-Lumen Scientific, Inc. "The U.S. represents one of the largest populations of patients with intermediate to advanced dry AMD, and conducting the study reflects our commitment to providing physicians and patients with a non-invasive, office-based therapeutic approach. We look forward to initiating U.S. enrollment."
The study has also reached an important operational milestone with the first participant successfully randomized and treated in the United Kingdom at London North West University Healthcare NHS Trust under the leadership of Ms. Christiana Dinah, Director of Research and Innovation. "This population of AMD patients with vision loss has very limited options, and the non-invasive nature of i-Lumen's approach makes it a particularly compelling area of investigation," said Dinah. "We are pleased that London North West is the first site in the United Kingdom to treat a participant in the i-SIGHT2 study."
AMD is a leading cause of vision loss worldwide in adults over the age of 50, affecting more than 230 million people globally, with prevalence expected to rise significantly over the next 10 years. Patients with intermediate to advanced dry AMD experience progressive central vision loss and have limited treatment options.
AMD results in vision loss due to the dysfunction of various retinal cells within the macula-the part of the retina that allows central vision. In the intermediate to advanced dry stages, central vision becomes distorted and disease progression leads to significant vision loss, making daily activities difficult, such as reading, driving and face recognition.
The retina has a complex electrophysiology which is affected by AMD and causes dysfunction of both photoreceptors-cells which process light to generate sight-and the retinal pigment epithelium (RPE)-a critical cell layer responsible for maintaining photoreceptor health and retinal function. i-Lumen's bioelectric stimulation therapy uses proprietary microcurrent stimulation to help improve RPE function and the electrophysiology of the retina.
"Bioelectric stimulation therapy offers a genuinely novel mechanism to address RPE dysfunction in intermediate to advanced dry AMD, and the i-SIGHT2 study is an important next step in evaluating its effectiveness," said Professor Timothy Jackson, Global Principal Investigator for the i-SIGHT2 study at King's College Hospital, London. "Expanding enrollment to the U.S. further strengthens the study's global reach and scientific rigor, and I look forward to the results of this study."
The i-SIGHT2 Study will provide important evidence regarding the effect of the i-Lumen AMD therapy on visual acuity for intermediate to advanced dry AMD patients with vision loss. If the study demonstrates a meaningful change in visual function, with an acceptable safety profile, it could support regulatory submission for commercialization in the U.S. and international markets. For now, investigators and clinicians will be watching closely as the trial advances enrollment across all sites.
Media Contact: Geoff Bremner Investor Relations i-Lumen Scientific, Inc. Phone: +1 (833) 938-2020 Email: pr@i-lumen.com
About i-Lumen Scientific, Inc.
i-Lumen Scientific is a leader in non-invasive, bioelectric stimulation therapy innovations in Ophthalmology for the treatment of intermediate to advanced dry age-related macular degeneration (AMD). The i-Lumen AMD System delivers stimulation to the retina designed to support the transepithelial potential (TEP) to improve RPE function and promote photoreceptor health, with the aim of improving retinal electrophysiology and visual acuity.
The i-Lumen AMD System is designed to address the underlying pathology of dry AMD and represents a novel office-based, non-invasive treatment option for millions of patients with dry AMD. The system is currently being clinically evaluated in the i-SIGHT2 Study.
Learn more at www.i-lumen.com
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