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 ValedaÔ 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.”