Espansione Group receives CE Mark approval for eye-light® photobiomodulation device

The clearance applies to treatment indications for age-related macular degeneration, blepharitis, chalazion, demodex blepharitis, ocular rosacea and post-blepharoplasty complications. Image credit: ©PR ART – stock.adobe.com

Italy-based medical technology company Espansione Group announced that its flagship photobiomodulation device, eye-light®, has received CE mark approval in the EU. The clearance applies to indications for age-related macular degeneration (AMD), along with a breadth of corneal conditions, including blepharitis, chalazion, demodex blepharitis, ocular rosacea and post-blepharoplasty complications.¹ This approval expands the device's uses beyond the existing therapeutic applications for dry eye disease.

In a news release, Espansione Group provided greater detail on the applications of the eye-light device. The device’s CE mark approval follows last month’s publication of initial results from the LightWave I clinical trial for AMD, presented at the Association for Research in Vision and Ophthalmology (ARVO) meeting and published in the ARVO journal. The new clearance expands upon the existing portfolio of indications for non-invasive ocular disease management.

Giuseppe Giannaccare, MD, PhD, FEBOphth, FWCRS, who is a professor of ophthalmology, chairman of the eye clinic and the director of the ophthalmology residency programme at the University of Cagliari, Italy, said a robust body of research supports the certification. He told Ophthalmology Times Europe, "The recent CE mark extension in new ocular fields, from the anterior to the poster segment of the eye, opens up new fascinating perspectives. Among all new indications, dry AMD represents the most interesting one, due to the social impact related to the epidemiological numbers and the lack of established treatments." He also addressed the additional data on AMD that will emerge in the coming months. "Preliminary results from a pilot study on patients with dry AMD showed impressive short-term results and we hope to enroll soon further patients to provide more robust body of evidence," Prof Giannaccare said.

Francesco Carones, MD, PCEO, FWCRS, who leads ADVALIA Vision in Milan, Italy, also spoke to the impact of the new approval. "Ocular surface disorders are becoming a major social problem, with great repercussions on the operation and efficiency, including working, of those suffering from it," he explained. Noninvasive therapeutics are vital for both improving the symptoms of ocular surface disease, and to help resolve postoperative symptoms after cataract and refractive surgery. Dr Carones also said, "The photobiomodulation for the treatment of the pathologies of the macula, so far practically untreatable, also allows to open a hope for all patients who until recently suffered the degeneration of the macula without being able to remedy, or brake evolution."

Last fall, Espansione Group released data from a study showing Light Modulation® Low-Level Light Therapy (LMLLLT) with eye-light as applied for dry eye disease, as well as preliminary results from LightWave I, the randomised controlled investigation of LMLLLT technology for dry AMD. In the case of dry eye disease², the research published in the British Journal of Ophthalmology indicated that prophylactic low-level light therapy could be implemented into a cataract surgery workflow to avoid development of iatrogenic DED.

Meanwhile, case studies from the LightWave I study showed that patients with AMD experienced significant visual gains following LMLLLT treatments.³ In the first case study, a 55-year-old male patient diagnosed with non-neovascular AMD observed improvement from 25 to 60 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and therapeutic effects at the cellular level. In the second case study, the patient was a 68-year-old female. At baseline, her best-corrected visual acuity was quantified at 50 letters on the ETDRS chart. Following treatment, she was reevaluated and a best-corrected visual acuity manifested an enhancement to 55 ETDRS letters and a complete resolution of certain soft drusen was observed.

In the release, Espansione Group indicated that additional regulatory approvals have been obtained which will enable the company to selectively transfer clearance to countries in the APAC, EMEA and LATAM regions. More information on treatment availability in those markets is forthcoming.¹

References

1. Espansione Group. eye-light® Device is Granted CE (MDR) Mark for Treatment of Dry AMD and Extended Anterior Segment Pathologies Unlocking New Horizons with Photobiomodulation. News release. Published 3 June, 2024.

2. Hayes H. Espansione Group shares new data from study on patients with surgery-induced dry eye. Ophthalmology Times Europe. Published 1 November, 2023. Accessed 3 June, 2024. https://europe.ophthalmologytimes.com/view/espansione-group-shares-new-data-from-study-on-patients-with-surgery-induced-dry-eye

3. Crago S. Espansione Group shares preliminary results from LightWave I, a multicentric, randomized controlled investigation of LM LLLT technology for dry AMD. Modern Retina. Published 5 October, 2023. Accessed 3 June, 2024. https://www.modernretina.com/view/espansione-group-shares-preliminary-results-from-lightwave-i-a-multicentric-randomized-controlled-investigation-of-lm-lllt-technology-for-dry-amd