Espansione Group shares preliminary results from LightWave I, a multicentric, randomized controlled investigation of LM LLLT technology for dry AMD

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Case 1 highlights the potential for this treatment for patients with dry AMD with noted letter gains

The image depicts LM LLLT technology from Espansione Group. Image courtesy of Espansione Group.

The clinical trial deployed Light Modulation® Low-Level Light Therapy (LM® LLLT) via the eye-light® system. Image courtesy of Espansione Group.

Espansione Group has released preliminary results1 from LightWave I, a multicentric, randomised controlled investigation which used the company’s patented photobiomodulation (PBM) technology to treat dry age-related macular degeneration (AMD).

In the press release1, Claudio Iovino, MD, one of the nine investigators involved in the study, noted the importance of understanding this condition’s impact and slowing the progression of AMD for patients. He said, “Age-related macular degeneration (AMD) is characterised by three stages: early, intermediate, and late (dry and wet). This relatively common retinal disorder progresses very slowly in some people and faster in others. Nevertheless, if a patient is affected by early-stage AMD, they may not even notice any visual loss for a long time before complications occur. LightWave I is an ongoing multicentric clinical trial focusing on patients with grade two and three AMD, according to the AREDS classification, treated with photobiomodulation. The real goal of the study is to provide a treatment able to significantly slow down the progression to the advanced stages of the disease. The results of the study, starting with these case reports, may shed a new light on the management of AMD, with positive repercussion also on the healthcare system and its related economics.”

Like Iovino, Enrico Borrelli, MD, stated that the research must continue to develop new solutions to conditions such as AMD because of the impact on visual acuity, and thus daily life. He said, “[…] the transition from early or intermediate age-related macular degeneration (AMD) to late-stage AMD, whether it's dry or neovascular, consistently leads to a substantial decline in visual acuity. Numerous risk factors, such as drusen volume, have been linked to this progression. Consequently, it becomes imperative to develop novel treatments targeted at mitigating this advancement and modifying these risk factors.”1

As a result of the LightWave I study, Espansione is sharing two cases1 where Light Modulation® Low-Level Light Therapy (LM®LLLT) with eye-light® was applied. The first case was that of a 68-year-old female patient with AMD. The second case is that of a 55-year-old male patient diagnosed with non-neovascular AMD observed a staggering rise in visual acuity from 25 to 60 ETDRS letters, accompanied by therapeutic effects at the cellular level.

In the first case, the patient was a 68-year-old female who was diagnosed with AMD classified under the age-related eye disease study (AREDS) category three. At baseline, the her best-corrected visual acuity was quantified at 50 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. She underwent a treatment protocol of bi-weekly session over a 4-week duration with the PBM employing LM® LLLT via the eye-light® system.

Following a one-month interlude post the culmination of the therapy, she was reevaluated and a best-corrected visual acuity manifested an enhancement to 55 ETDRS letters. Additionally, a complete resolution of certain soft drusen was observed.

In the study released1 on Espansione’s website, Prof Giuseppe Giannaccare from the University of Cagliari, another investigator involved in LightWave I, said the following: “Low-level light therapy is a groundbreaking technology able to cure different eye diseases by acting at the root of the cellular dysregulation. From the first successful studies in the setting of ocular rosacea, MGD and other ocular surface diseases, this technology has been translated to the back of the eye where the perspective of halting the progression of dry age-related macular degeneration opens up a new fascinating scenario.”

Along with the investigators of the study, Matteo Corbellino, chief marketing and innovation officer at Espansione Group, commented on the Lightwave I results, saying, "These breakthroughs encapsulate what Espansione stands for, and our unyielding commitment to evidence-based progress. We're excited to be at the forefront of this industry-wide journey to redefine AMD treatment, and look forward to releasing more robust evidence of LM® LLLT’s ability to change people’s lives soon enough.”1

Further information, including the second case from this study, can be found at https://espansionegroup.it/newsroom/lightwave-i-casereport/.

Reference:
  1. LightWave I: Case Reports from a Disruptive Multi-centric Clinical Trial Employing LM® LLLT (PBM) Technology in Dry AMD. Espansione Group. October 5, 2023. Accessed October 5, 2023. https://espansionegroup.it/newsroom/lightwave-i-casereport/
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