BLOOMINGTON, Minn., March 31, 2026 /PRNewswire/ — i-Lumen Scientific, Inc., a leader in energy-based innovations for ophthalmology, and its non-invasive bioelectric stimulation therapy for the treatment of intermediate to advanced dry age-related macular degeneration (AMD) today announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) to initiate enrollment in the U.S. in the i-SIGHT2 Pivotal Study. The study is evaluating the effect of i-Lumen’s AMD therapy on visual acuity in patients with vision loss due to intermediate to advanced dry AMD.

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.