i-Lumen Scientific receives FDA approval of IDE to initiate U.S. enrollment in i-SIGHT2 clinical study for dry AMD
IDE approval by the FDA expands global trial to the United States as first study participant is treated in the United Kingdom
21 Apr 2026
i-Lumen Scientific, Inc. has 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 age-related macular degeneration (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.
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."
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.