Photobiomodulation device firm, LumiThera, has announced the launch of a new clinical registry study designed to collect safety and efficacy data from patients living with dry age-related macular degeneration (AMD) treated with light-based therapy.
Related: Endovascular Engineering secures IDE for pivotal Helo thrombectomy trial
Dubbed the EUROLIGHT study, the trial will aim to collect outcome data from between 500 and 1000 patients at sites throughout the continent, who had previously undergone photobiomodulation therapy. It will also examine efficacy outcomes such as best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) imaging data taken from each subject. Specifically examining patients treated with the Valeda Light Delivery System.
It comes off the back of another series of trials run by LumiThera, known as the LIGHTSITE studies, the second of which LIGHTSIDE II (NCT03878420) enrolled 44 non-exudative AMD subjects, and was able to see a statistically significant improvement in BCVA at 9 months.
Oygunn Uthiem, trial investigator at the Norwegian Dry Eye Clinic where part of the trial is set to take place, said: “We are thrilled to be part of the EUROLIGHT study. We have treated over 350 patients in the last four years and have seen the real-world benefits of Valeda treatments in our patients.
Shortly after the LIGHTSIDE III trial (NCT04065490) was able to demonstrate positive efficacy and safety results in 100 subjects with dry AMD.
“We have started to upload data into the registry database and have obtained over 70 informed consents from patients who want to be part of the study. Our patients have strictly followed the clinical trial protocols and been tested every 4-6 months, some for up to four years.”
In January LumiThera submitted a de novo request to reclassify its Valeda light delivery system as a Class II device in the United States following feedback from the US Food and Drug Administration. The device was previously marketed in the US as treatment for AMD, but was advised its best path to market was to seek reclassification.
Currently, LumiThera’s Valeda Light Delivery System is marketed in Europe and across Central and South America for the indication of AMD, with it being available in Europe for other indications such as Diabetic Macular Edema and Diabetic Retinopathy.
Clark Tedford, CEO of LumiThera, added: “We have seen recent publications from the real-world setting that mirror our RCT trial results and we have several years of experience with Valeda treatments in the EU.”
LumiThera is not the only company working on bringing photobiomodulation devices to market, In May of 2023 Health Canada approved Vielight’s device to boost the recovery of Covid-19 patients.
