London North West University Healthcare NHS Trust

i-Lumen Scientific Receives FDA IDE Approval to Expand Bioelectric Stimulation Trial for Dry AMD to U.S.

- i-Lumen Scientific received FDA Investigational Device Exemption approval to initiate U.S. enrollment in the i-SIGHT2 pivotal study evaluating bioelectric stimulation therapy for intermediate to advanced dry AMD. - The global trial will enroll 120 participants across multiple countries, with the first patient already treated in the United Kingdom and U.S. enrollment expected to begin in late April 2026. - The non-invasive therapy uses proprietary microcurrent stimulation delivered via electrodes to improve retinal pigment epithelium function and address underlying dry AMD pathology. - Previous feasibility data showed over 50% of treated patients achieved ≥2 lines of visual acuity improvement at 3 months, supporting advancement to this pivotal trial.