SEATTLE, November 7, 2017 /PRNewswire/ — LumiThera Inc., a clinical stage medical device company focused on developing non-invasive photobiomodulation (PBM) therapies for ocular disorders and disease, today announced topline interim results from the LIGHTSITE I 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 one 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,” stated Samuel Markowitz, M.D., Co-Principal Investigator, Department of Ophthalmology and Vision Sciences, University of Toronto. “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,” stated Clark Tedford, Ph.D., LumiThera President and CEO. “The LIGHTSITE I 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 provides further refinement opportunities in the design of the upcoming multi-center 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,” says Dr. Robert Devenyi, Co-Principal Investigator, Ophthalmologist-in-Chief and Director of Retinal Services, UHN, University of Toronto. “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 I 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
About LumiThera Inc.
LumiThera is a clinical-stage medical device company focused on treating people affected by ocular disorders and diseases including dry age-related macular degeneration, a leading cause of blindness in adults over 65. The Company is a leader in the use of photobiomodulation using non-invasive light emitting diodes (“LED”) for treatment of acute and chronic ocular diseases and disorders. The Company is developing the LED office-based LT-300 instrument to be used by ophthalmologists and other eye specialists as non-invasive medical treatments.
The LT-300 is not yet approved for use by the Food & Drug Administration (FDA) in the USA. The device has not yet been granted a CE Mark by a Notified Body for commercial use outside of the USA.
2017 LumiThera Inc., All rights reserved.