The eye-light device, distributed in Australia by Ophthalmopro, has been granted CE medical device classification approval for the treatment of dry age-related macular degeneration (AMD) and an extended range of anterior segment conditions.
The clearance expands the device’s uses beyond the existing therapeutic applications for dry eye disease, applying to indications for AMD, along with an array of corneal conditions, including blepharitis, chalazion, demodex blepharitis, ocular rosacea and post-blepharoplasty complications (i.e., ptosis and ectropion).1
The announcement from manufacturer Espansione Group comes shortly after the publication of the first results from the LightWave I clinical trial in May 2024, which focussed on AREDS 2 and 3 age-related macular degeneration (Dry), by the Association for Research in Vision and Ophthalmology (ARVO).
Espansione Group initially obtained clearance of the eye-light photobiomodulation device in ophthalmology almost a decade ago. In a media release the company said “the clearance marks a potential breakthrough in how the workflow of dry AMD patients is currently managed and opens new opportunities to investigate the effectiveness of photobiomodulation on retinal conditions”.
“In addition to EU27 countries, additional clearances have been obtained and will enable the Group to selectively transfer this clearance to other key countries in EMEA (Europe, Middle East, and Africa), LATAM (Latin America), and APAC (Asia Pacific), making these breakthrough treatment protocols available to a wide number of patient populations.”
Reference
- 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.
