Espansione_Clinical Trial for Dry AMD 02

Espansione Announces Six-Month Results from the Lightwave I Clinical Trial for Dry AMD Patients

Espansione Group (Argelato, Italy), a provider of photobiomodulation (PBM) medtech solutions for ophthalmology, has announced the six-month safety, tolerability and short-term efficacy results from their LightWave I clinical trial, which explored the impact of Light Modulation® low-level light therapy (LM® LLLT) on patients with dry age-related macular degeneration (dAMD). 

The results, published in the September issue of Springer’s Ophthalmology and Therapy, underline the safety, tolerability, and efficacy of Espansione’s LM LLLT on the Eye-light® PBM device. The study included 152 eyes from 76 patients and revealed improvements in both best-corrected visual acuity (BCVA) and drusen volume reduction, making it a potential game-changer for dAMD management.

All patients in the study showed high compliance with treatment protocols, and only mild ocular adverse events were reported by one-fifth of the patients in the PBM-treated group. This reinforces the therapy’s non-invasive nature and patient-friendliness.1

Best corrected visual acuity (BCVA) improvements were statistically significant, with 20.3% of PBM-treated patients achieving a gain of five or more letters post-treatment, compared to 8.9% in the sham group (p=0.043). In addition, drusen volume reductions were significantly greater in the PBM-treated group compared to the sham group (p=0.013). These results highlight PBM’s potential to not only stabilize but also enhance visual function in patients with dAMD.1

Given the growing global challenge of managing AMD, these results could herald a new era in the treatment of early and intermediate stages of the disease. The ability to reduce drusen, a key marker of dAMD progression, and improve visual outcomes without invasive procedures may provide an invaluable option for clinicians.

“The LightWave I trial represents a major milestone deepening our understanding of light therapy’s impact in the management of degenerative retinal conditions such as dry AMD,” noted lead investigator Prof. Enrico Borrelli (Italy) in a news release.

As Espansione continues with the LightWave I multicenter research effort, the ophthalmic community eagerly anticipates more long-term results with photobiomodulation, hoping that it can offer patients a durable, non-invasive solution to slow dAMD disease progression and improve patients’ quality of life.

Reference

  1. Borrelli E, Coco G, Pellegrini M, et al. Safety, tolerability and short-term efficacy of low-level light therapy for dry age-related macular degeneration. Ophthal Ther. 13 September 2024. Epub ahead of print. Available at: https://link.springer.com/article/10.1007/s40123-024-01030-w. Accessed on 21 September 2024.
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