SEATTLE, Oct. 1, 2019 /PRNewswire/ — LumiThera Inc., a commercial stage medical device company delivering photobiomodulation (PBM) treatment for ocular disorders and disease, today announced it has begun enrolling patients in a multi-center United States clinical study in dry Age-Related Macular Degeneration (AMD) patients.
The randomized, multi-center study called LIGHTSITE III enrolled and treated the first patient at Cumberland Valley Retina in Hagerstown, Maryland. The United States study is being conducted in leading retinal centers throughout the United States. The study will enroll approximately 100 patients suffering from dry AMD and treat them over the course of two years. In addition to demonstrating safety, key efficacy endpoints include visual acuity, contrast sensitivity and reduction of drusen deposits.
In February, the company announced that the National Institute of Health and the division of the National Eye Institute was providing a $2.5M grant to partially support the U.S. study.
“This is an exciting opportunity to establish a potential new treatment for dry AMD patients” remarked Allen Hu, M.D. (Principal Investigator, Cumberland Valley Retina Consultants). “The previous work with PBM has been very promising. Our center has been involved in many drug studies with the wet form of AMD, but this study critically provides an important medical device treatment for the majority of patients with intermediate dry AMD and limited options.”
LumiThera has already obtained a CE mark authorization to commercialize the Valeda™ Light Delivery System in the European Economic Area for the treatment of dry AMD. The separate LIGHTSITE II study is an ongoing post-marketing study with top retinal centers in key European countries and was initiated earlier in the year.
“The LIGHTSITE III study has engaged eight top U.S. retinal centers to evaluate the Valeda,” stated Eleonora Lad, M.D., Ph.D. (Principal Investigator, Duke University). “We are now actively screening patients and will be measuring multiple vision outcome measures. The Duke Imaging Center with Dr. Glenn Jaffe will also be evaluating retina images for all study centers involved to determine if we are improving the health of the eye during the course of the trial. This is a major study that will establish a novel treatment for these elderly patients and could have a big impact on their quality of life.”
“We have two multi-center trials currently underway, one in Europe and one in the U.S.,” stated Clark Tedford, Ph.D., President and CEO. The data from these trials will be used to further support our commercialization efforts and global regulatory submissions. We have enlisted top private retinal and University centers in the U.S. for the LIGHTSITE III trial and if successful, the study would allow an important treatment choice in the prevention of vision loss for patients here.”
About LumiThera Inc.
LumiThera is a commercial-stage medical device company focused on treating people affected by ocular disorders and diseases including dry AMD, a leading cause of blindness in adults over 65. The company is a leader in the use of PBM for treatment of acute and chronic ocular diseases and disorders. The company is developing the office-based Valeda Light Delivery System to be used by eye care specialists as medical treatments.
The Valeda Light Delivery System has been granted authorization to use the CE Mark by an EU Notified Body as required for commercial use in the European Economic Area only. Valeda is not approved for use by the Food & Drug Administration (FDA) in the USA.
“Fantastic day. Has to be one of the best seminar / study days I have been on in 38 years of nursing. Consolidated some of my knowledge whilst giving me more to replace. Dealt with all of the concerns I had regarding PBM and use of lasers in general. A great bunch of people as well. Thank you for a great day.”
David Brown had pain in both shoulders that required shoulder replacement surgery. After a series of photobiomodulation treatments 5 years ago at HOPE Laser Institute, David has continued to have relief from pain and able to function thus has avoided the need to undergo surgery.
Craig Hackman suffered with chronic back and knee pain most of his life as was into sports, dancing, acting and singing. Overuse through the years had lead to his issues. By going to HOPE Laser Institute for photobiomodulation treatment, he is now pain free in those areas where he hadn’t been pain free for years. Craig now has full range of motion, no pain and not needing to take pain pills which he had been using for the last 10 years.