BLOOMINGTON, Minn., USA, March 31, 2026
i-Lumen Scientific has received FDA Investigational Device Exemption (IDE) approval to initiate U.S. enrollment in its i-SIGHT2 pivotal clinical study, marking a major milestone in the development of a non-invasive bioelectric stimulation therapy for dry age-related macular degeneration (AMD). The approval enables expansion of the global trial into the United States, strengthening the study’s clinical and regulatory significance as it evaluates improvements in visual acuity in patients with intermediate to advanced dry AMD.
FDA IDE Approval Expands Global Clinical Trial
The FDA IDE approval allows i-Lumen to begin patient enrollment in the United States, adding to ongoing recruitment efforts across the United Kingdom, Australia, and New Zealand. The i-SIGHT2 study is expected to enroll approximately 120 participants globally, making it a significant multi-center clinical trial designed to generate robust data on the therapy’s effectiveness and safety.
The study has already achieved an important milestone with the first patient successfully treated in the United Kingdom, demonstrating operational readiness and early clinical progress. The inclusion of U.S. sites is expected to enhance data diversity, regulatory alignment, and scientific rigor, which are critical for future regulatory submissions and commercialization strategies.
Innovative Bioelectric Therapy Targets AMD Pathology
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i-Lumen’s investigational therapy is based on bioelectric microcurrent stimulation designed to improve retinal function, specifically targeting the retinal pigment epithelium (RPE) and photoreceptor cells. By enhancing retinal electrophysiology, the therapy aims to restore visual function and slow disease progression in patients suffering from dry AMD, a condition with limited treatment options.
Dry AMD is a leading cause of vision loss globally, affecting over 230 million people worldwide, particularly individuals over the age of 50. The disease leads to progressive central vision loss, significantly impacting daily activities such as reading, driving, and facial recognition. The non-invasive nature of i-Lumen’s approach offers a potential breakthrough in ophthalmology, as it provides an office-based treatment alternative without the need for surgical intervention.
Clinical and Regulatory Implications for Future Approval
The i-SIGHT2 study is designed to evaluate whether the therapy can deliver meaningful improvements in visual acuity while maintaining an acceptable safety profile, which are key requirements for regulatory approval. Positive results from the trial could support future submissions to the FDA and other global regulatory authorities, paving the way for commercialization.
The expansion into the U.S. market is particularly significant, as it represents one of the largest patient populations affected by dry AMD, and provides an opportunity to generate data aligned with FDA regulatory expectations. The study also benefits from collaboration with leading clinical investigators, further enhancing its credibility and scientific value.
A Promising Step in AMD Treatment Innovation
The FDA IDE approval for the i-SIGHT2 study marks a critical advancement in the clinical development of non-invasive therapies for dry AMD, highlighting the growing role of device-based innovations in addressing unmet medical needs. As enrollment progresses across global sites, the study is expected to deliver valuable insights into the efficacy, safety, and clinical potential of bioelectric stimulation therapy in ophthalmology.
Source: i-Lumen Scientific press release
