LumiThera today announced topline interim results from the Lightsite 1 trial of its LT-300 photobiomodulation device designed to treat dry age-related macular degeneration, touting statistically significant vision benefits maintained to 3 months.
Data came from the 30-patient pilot study of the device, funded by a Small Business Innovation Research grant from the National Institute of Health and National Eye Institute. The trial is slated to follow patients undergoing photobiomodulation therapies for up to 1 year.
“We have examined the interim data from the Lightsite I study for up to the first 3 months following treatment with a multi-wavelength PBM therapy and results have demonstrated statistically significant vision benefits in dry AMD patients that were maintained for the 3 month interval. The PBM treatment was most beneficial in AMD patients with better vision reaching statistically significant benefits in both visual acuity and contrast sensitivity,” co-principal investigator Dr. Samuel Markowitz of the University of Toronto said in a prepared statement.
“LumiThera has demonstrated intriguing early data in this prospective, sham controlled, double-masked pilot clinical dry AMD study. The results show PBM using the LT-300 device can improve vision for dry AMD patients and could be an important option for these patients to counteract the degradation in vision that this disabling disease brings,” co-principal investigator Dr. Robert Devenyi of the University of Toronto said in a press release.
LumiThera said the trial has reached full enrollment with a targeted completion date next year, and that patients will undergo a second round of treatment at 6 months.
“These early clinical results allow us to better understand the dry AMD patient response and provides further refinement opportunities in the design of the upcoming multi-center clinical trials expected to start in Europe in 2018,” prez & CEO Clark Tedford said in a prepared release.
Last month, Lumithera said it raised $5.5 million in a Series B round of financing to support the development of its LT-300 device.