SEATTLE, May 1, 2018 /PRNewswire/ — LumiThera Inc., a clinical stage medical device company focused on developing non-invasive Photobiomodulation (PBM) therapies for ocular disorders and disease, presented topline final results from the LIGHTSITE I clinical trial for the treatment of dry age-related macular degeneration (AMD) utilizing its LT-300 Light Delivery System.
The LIGHTSITE I data was presented at the 2018 Association for Research in Vision and Ophthalmology (ARVO) annual conference by Marion Munk, MD, PhD, Department of Ophthalmology/Bern Photographic Reading Center and Managing Director, Bern Photographic Reading Center, University Hospital Bern. Dr. Munk was part of the investigator team.
“LumiThera PBM treatment demonstrated reductions in central drusen volume over the course of the one-year study versus the sham treatment with statistical significance at one year, (p = 0.05). Drusen is the hallmark pathology of dry AMD and is an important proinflammatory mediator and marker for disease progression,” says Dr. Munk.
“Results from the LIGHTSITE I study following treatment with a multi-wavelength PBM treatment demonstrated clinical improvements in vision outcome measures providing a strong foundation for initial therapy as well as the need for follow-up maintenance therapy,” stated Samuel Markowitz, M.D., Co-Principal Investigator, Department of Ophthalmology and Vision Sciences, University of Toronto. “The PBM therapy was most beneficial in dry AMD patients immediately following the completion of the treatment sessions. Contrast sensitivity or detailed vision was significantly improved throughout the year. Retreatments at a 6 month interval were performed to maintain clinical benefits.”
“We are excited by the completion of the LIGHTSITE I trial and seeing the benefits in both clinical outcomes and drusen pathology,” stated Clark Tedford, Ph.D., LumiThera President and CEO. “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. The current trial results will be used to refine the upcoming multi-center clinical trials expected to start initially in Europe.”
“LumiThera’s LIGHTSITE I data is the first prospective, sham controlled, double-masked, pilot clinical dry AMD study with PBM,” 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 Visual Acuity and Contrast Sensitivity as vision endpoints for dry AMD patients to counteract the degradation in vision that this disabling disease brings.”
The 30-subject pilot study was partially funded from a Small Business Innovation Research (SBIR) grant awarded to the Company from the National Institute of Health and the National Eye Institute. The trial tested each subject’s vision and examined disease pathology in the eye, following PBM treatments for up to one year.
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 for treatment of acute and chronic ocular diseases and disorders. The Company is developing the office-based LT-300 Light Delivery System 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.
2018 LumiThera Inc., All rights reserved.
SOURCE LumiThera Inc.