i-Lumen Scientific Inc, a developer of non-invasive, bioelectric stimulation therapy innovations in ophthalmology for the treatment of intermediate to advanced dry age-related macular degeneration (AMD), announced on Tuesday that it has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to initiate enrolment in the United States 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.

i-Lumen says that 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 enrol 120 participants across all sites, with US enrolment anticipated to begin in late April 2026.

The i-SIGHT2 Study is expected to provide 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 commercialisation in the US and in international markets.