LumiThera said that the LIGHTSITE I clinical trial for the treatment of dry age-related macular degeneration (AMD) using its LT-300 Light Delivery System has demonstrated better results.
The LT-300 Light Delivery System is being developed by the US-based clinical stage medical device company for the treatment of sight threatening, acute and chronic ocular disease by a using non-invasive photobiomodulation (PBM) therapy.
LIGHTSITE I is a 30-subject prospective, randomized, double masked, pilot study that evaluated each patient’s vision and studied disease pathology in the eye, after subjecting them to PBM treatments for up to one year.
In the study, the PBM treatment using the LT-300 device was shown to significantly reduce the central drusen volume during the course of the one-year study in comparison to sham, after one year of treatment.
Drusen is the major pathology of dry AMD and is considered to be a key proinflammatory mediator and marker for disease progression, said Marion Munk, who was part of the investigator team of LIGHTSITE I.
Further, contrast sensitivity or detailed vision was improved significantly throughout the year while retreatments at a six-month interval were carried out to sustain clinical benefits, said Samuel Markowitz, the co-principal investigator of the trial.
LumiThera president and CEO Clark Tedford said: “The LT-300 Light Delivery System performance was excellent throughout the clinical trial and patients provided positive feedback from their PBM treatment experience over the course of a year.
“This foundational data will accelerate our learning to develop options to treat complicated degenerative eye disease, where patient options are limited. The results demonstrate that the therapy is both a safe and effective treatment for early stage dry AMD patients.”
LumiThera plans to use the current trial results of LIGHTSITE I to refine its forthcoming multi-center clinical trials which are likely to begin initially in Europe.
LIGHTSITE I was partially sponsored by a Small Business Innovation Research (SBIR) grant given to LumiThera by the National Institute of Health and the National Eye Institute in the US.