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Espansione Group’s eye-light® Expands Its Horizons: New CE (MDR) Mark for Corneal and Retinal Care

Espansione Group (Zona Artigianale Funo BO, Italy), a leader in medtech innovation in ophthalmology, announced today a major milestone for its photobiomodulation (PBM) device, eye-light®. Known in the ophthalmology community as a novel treatment for dry eye disease (DED), eye-light has now received the CE (MDR) Mark for a broad range of ocular conditions, including dry age-related macular degeneration (AMD). This marks a new chapter in non-invasive eye care, with the potential to transform the lives of millions worldwide.

“Espansione has been the first player to develop and obtain clearance of a photobiomodulation device in ophthalmology, almost a decade ago, revolutionizing dry eye treatment,” said Alessandro Fier, CEO of Espansione Group, in a news release. “These new clearances enable us to offer an unmatched portfolio of effective treatments on our tech platforms to European eye care professionals.”1

With this new CE approval, eye-light can now be used to treat a variety of conditions, expanding its utility from the front to the back of the eye. Here’s a rundown of the newly approved conditions:

  • Anterior Segment: chalazion, blepharitis, demodex and demodex blepharitis, rosacea and ocular rosacea, and post-blepharoplasty complications (ptosis & ectropion)
  • Posterior Segment: age-related macular degeneration

To explore the clinical implications of this advancement, we spoke with two experts: Professor Giuseppe Giannaccare, a PBM specialist collaborating closely with Espansione, and Dr. Chris Lim, an anterior segment specialist using the eye-light device for ocular surface conditions.

Espansione Group’s eye-light® Expands Its Horizons: New CE (MDR) Mark for Corneal and Retinal Care

The good news

eye-light’s proven effectiveness in treating dry eyes and meibomian gland dysfunction has paved the way for exploring the benefits of its technology in other ocular conditions. 

Besides DED and meibomian gland dysfunction, Dr. Lim has utilized eye-light to treat chalazion, styes and demodex blepharitis. “Many of our patients have experienced improvements in clinical parameters following treatment,” he reported. 

“We also found it useful as treatment for pediatric patients with poorly controlled blepharokeratoconjunctivitis,” added Dr. Lim. “This has been offered to a limited number of patients and the results have been encouraging.”

For patients suffering from dry AMD, a leading cause of severe vision loss, the CE Mark isn’t just a regulatory win, it’s a beacon of hope.2,3 The clearance signifies a potential breakthrough in managing the workflow in treating dry AMD patients and opens new opportunities to further evaluate the effectiveness of photobiomodulation on retinal conditions, according to the company.

“About a year ago, we started using photobiomodulation in patients with dry age-related macular degeneration,” said Prof. Giannaccare. “Preliminary analysis of the first cycle of treatment showed significant improvements in drusen reduction and visual acuity, which we hope to publish soon.”

An Espansione news release presenting LightWave 1 case studies highlighted the potential of PBM in managing this debilitating condition. One patient with AREDS Category 3 AMD experienced an improvement in visual acuity from 50 to 55 ETDRS letters after treatment. Another patient with non-neovascular AMD saw a remarkable increase in visual acuity from 25 to 60 ETDRS letters, along with significant therapeutic effects at the cellular level.4

The success of eye-light treatment for various ocular conditions and dry AMD can be attributed to its state-of-the-art technology.

Cutting-edge tech

eye-light leverages a light-based PBM known as Light Modulation® Low-level Light Therapy (LM® LLLT) which uses specific wavelengths of light to stimulate cellular activity, reduce inflammation and promote healing.

“The mechanism of action is currently not fully understood,” said Prof. Giannaccare. “But the main proposed hypothesis is that photobiomodulation promotes ATP and other mechanisms that can stimulate and replicate cells.” 

LM LLLT is a sophisticated evolution of a NASA-developed patent that originally used invasive lasers. By enhancing this concept with medical-grade LEDs and advanced software control, Espansione has successfully adapted it for ophthalmology use, without causing side effects or pain.5

“Some patients have found it rather bright initially but most get used to it, with some remarking that it feels like they’re in a spa.” said Dr. Lim. “We’ve only had one patient out of hundreds who could not tolerate the brightness. Having said that, we’ve treated patients as young as four years of age who had no trouble with the mask.”

Another advantage of eye-light, compared to other PBM devices, is that it treats both eyes at the same time. “You don’t need to treat one eye, then move and treat the other eye,” said Prof. Giannaccare.

eye-light is also user-friendly, requiring minimal effort from medical professionals. “With other devices, you have to stay in front of the device and center the device in front of the eye,” Prof. Giannaccare noted. “With eye-light, you can put the mask on and leave the patient alone in the room during treatment.”

 “The advantages of this treatment is that the device is safe, pain-free, affords minimal downtime for patients, effects are independent of the operator, and is a relatively short procedure,” summarized Dr. Lim.

Given its cutting-edge technology, proven efficacy and new CE (MDR) Mark, what lies on the horizon for eye-light?

Looking ahead

When asked about the future of eye-light, Prof. Giannaccare expressed optimism. “We have produced a lot of evidence-based material on the benefits of photobiomodulation, but there’s still so much to investigate with this technology in the ocular field,” he remarked. “There are potentially no limits to application.”

“We are about to publish a case report involving a patient with serious retinal detachment that was successfully treated with biomodulation,” shared Prof. Giannaccare. “So it can help with all sorts of retinal diseases, not only dry age-related macular degeneration.”

Expanding on the potential applications, Prof. Giannaccare added, “And there are other areas of interest for photobiomodulation treatment, like myopia and glaucoma, where there is no robust data as of yet.”

Dr. Lim echoed the need for future research, “We need to better understand the exact underlying mechanism of action that underpins photobiomodulation and document its effects at the cellular and molecular level.”

“There also needs to be optimization of treatment regimes based on this knowledge, as a wide range of regimens are currently used in reported studies. This may have contributed to the heterogenous outcomes achieved for certain conditions.” Dr. Lim added.

As eye-light opens new doors for treating both anterior and posterior eye conditions, the future of ophthalmic care looks incredibly promising. For practitioners seeking to integrate advanced, non-invasive treatments, eye-light stands out as a leading innovation in the field.

References

  1. Espansione Group, “eye-light® Device is Granted CE (MDR) Mark for Treatment of Dry AMD and Extended Anterior Segment Pathologies,” news release, June 3, 2024.
  2. Ayoub T, Patel N. Age-related macular degeneration. J R Soc Med. 2009;102(2):56-61.
  3. Cabral de Guimaraes TA, Daich Varela M, Georgiou M, et al. Treatments for dry age-related macular degeneration: therapeutic avenues, clinical trials and future directions. Br J Ophthalmol. 2022;106(3):297-304.
  4. Espansione Group, “LightWave I Case Reports from a Disruptive  Multi-centric Clinical Trial Employing LM® LLLT (PBM) Technology in Dry AMD,” news release, October 5, 2024. Available at: https://espansionegroup.it/newsroom/lightwave-i-casereport/. Accessed on June 2, 2024.
  5. Cannas C, Pintus B, Corgiolu L, et al. Current applications and future perspectives of photobiomodulation in ocular diseases: A narrative review.” Appl Sci. 2024;14(6):2623.

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