LumiThera announced topline interim results from the LIGHTSITE 1 trial for treatment of dry age-related macular degeneration (AMD) trial utilizing its LT-300 device. The 30-subject pilot study funded from a Small Business Innovation Research (SBIR) grant awarded to the company from the National Institute of Health and the National Eye Institute is testing each subject's vision and examining disease pathology in the eye, following PBM treatments for up to 1 year.
"We have examined the interim data from the LIGHTSITE 1 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," Samuel Markowitz, MD, Co-Principal Investigator, Department of Ophthalmology and Vision Sciences, University of Toronto, said in a company news release. "The PBM treatment was most beneficial in AMD patients with better vision reaching statistically significant benefits in both visual acuity and contrast sensitivity (P<0.05)."
"We are encouraged by these interim clinical results which are consistent with outcomes we have seen previously," Clark Tedford, PhD, LumiThera President and CEO, said in the news release. "The LIGHTSITE 1 clinical trial is fully enrolled and targeted to complete in 2018. Patients will undergo a second series of treatments at the 6-month time point. These early clinical results allow us to better understand the dry AMD patient response and provide
s further refinement opportunities in the design of the upcoming multicenter clinical trials expected to start in Europe in 2018."
"LumiThera has demonstrated intriguing early data in this prospective, sham controlled, double-masked pilot clinical dry AMD study," Robert Devenyi, MD, Co-Principal Investigator, Ophthalmologist-in-Chief and Director of Retinal Services, UHN, University of Toronto, said in the news release. "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."
The LIGHTSITE 1 data will be presented at the 2017 American Academy of Ophthalmology Conference in New Orleans on November 12th. Visit the company's website at www.lumithera.com.