#USA #Bloomington #Retinal Disease #Bioelectric Therapy #i-Lumen AMD

i-Lumen's i-SIGHT Feasibility Study: A Breakthrough in AMD Treatment

On November 10, 2026, i-Lumen Scientific, Inc., a pioneer in medical technology focused on bioelectric therapies, presented the notable results of the i-SIGHT feasibility study during the Clinical Trials at the Summit Retina Meeting. This randomized, sham-controlled trial aimed to assess the efficacy and safety of the i-Lumen AMD System in patients suffering from intermediate to advanced nonexudative age-related macular degeneration (AMD).

Overview of the Study

The i-SIGHT study involved 30 participants across ten retina centers in the United States, targeting individuals experiencing vision loss due to AMD. Each participant underwent an initial five-day treatment regimen followed by two additional treatment sessions during months one and two. The study tracked various metrics, including safety, visual function, retinal electrophysiology, and structural biomarkers, extending to a 12-month follow-up period.

The i-Lumen AMD System is still under investigation; it is designed to deliver non-invasive bioelectric therapy through low-level microcurrent stimulation via the eyelid. This innovative approach seeks to stimulate retinal bioelectrical signaling, potentially restoring the transepithelial electrical potential (TEP) of the retinal pigment epithelium (RPE), which is critical for maintaining retinal health and photoreceptor performance.

Key Findings and Results

Dr. Sophie J. Bakri, a prominent figure in ophthalmology at Mayo Clinic, shared the study's findings, which indicate:

• - The active study eyes exhibited a mean improvement of +9.62 ETDRS letters after three months, showing substantial enhancements in visual acuity.
• - Further exploratory analyses revealed that the treated eyes had significant advantages over untreated fellow eyes and sham-treated eyes, suggesting that the therapy indeed has a positive effect.
• - Notably, over 50% of participants achieved a ≥10-letter improvement in best-corrected visual acuity at one or more follow-ups within months 2 to 12.
• - Additionally, multifocal electroretinography (mfERG) data indicated improvements in photoreceptor response times correlated with better visual outcomes.
• - Optical coherence tomography (OCT) assessments showed enhanced ellipsoid zone integrity during treatment, with improvements sustained up to three months.
• - Importantly, no unexpected adverse events associated with the device were reported, ensuring the safety of participants.

These results, while preliminary and not designed to establish definitive efficacy, show promising signs that retinal bioelectric stimulation could positively influence visual function in individuals with AMD. Dr. Bakri noted the need for larger, controlled clinical trials to validate these initial findings.

The Significance of AMD Treatment Advances

AMD remains a significant contributor to irreversible vision loss globally. Current treatment options have advanced for geographic atrophy; however, there is still a profound need for effective therapies that can help patients earlier in the disease process.

John VeLure, CEO of i-Lumen Scientific, expressed optimism about the data, emphasizing its importance in pursuing new treatment pathways for AMD patients. He stated, "The i-SIGHT findings contribute to a growing body of evidence supporting bioelectric stimulation as a novel therapeutic approach for these patients."

Following the encouraging results, i-Lumen has initiated a larger pivotal trial, the i-SIGHT2 Study, which is already enrolling participants in both the United States and the United Kingdom.

About i-Lumen Scientific

Founded to develop bioelectric therapies targeting retinal disease, i-Lumen Scientific, Inc. aims to address cellular dysfunction via microcurrent stimulation. This innovative approach seeks to restore the physiological electrical signaling within the retina, offering hope for improving the lives of individuals battling vision-threatening diseases, starting with AMD.

In conclusion, the i-SIGHT feasibility study represents a pivotal point in the quest for advanced treatment options for AMD, illuminating potential avenues for enhancing visual outcomes for patients dealing with this challenging condition.