LumiThera announced that it is a recipient of a small business innovative research (SBIR) phase 2 grant from the National Institute of Health (NIH) and the division of the National Eye Institute (NEI). The grant supports a prospective, randomized, multicenter human clinical trial in U.S. subjects diagnosed with dry age-related macular degeneration (AMD.)
The LIGHTSITE 3 trial, which is subject to FDA Investigational Device Exemption (IDE) approval, will test vision and examine disease pathology in the eye following PBM treatments using the company’s Valeda Light Delivery System. Subjects will be followed for up to 2 years. In 2018, LumiThera obtained a CE mark to commercialize the Valeda Light Delivery System in Europe for the treatment of dry AMD. A companion post-marketing study (LIGHTSITE 2) is being readied for Europe.
“Dry AMD is one of the largest unmet medical needs in medicine and its prevalence is increasing as we live longer,” Quan Dong Nguyen, MD, MSc, and Diana V. Do, MD, both professors of ophthalmology at the Byers Eye Institute, Stanford University School of Medicine, said in a company news release. “In ophthalmology, currently, we have no therapies that can be offered to these patients. Both of us and many of our colleagues at Stanford, in the US, and throughout the world recognize the potential that PBM could provide as an early treatment for dry AMD, and if so, can bring significant benefits to millions of patients globally.”
“The LIGHTSITE 2 and 3 trials are part of LumiThera’s global efforts to bring forward a treatment for a debilitating eye disease that results in central loss of vision,” David Boyer, MD, Retina-Vitreous Associates Medical Group, Los Angeles, said in the news release. “The planned European and US trials would create a novel treatment option for dry AMD patients, who currently have limited choices.”
“The NIH clinical grant is substantial in providing over $2.5M in funding to develop a PBM therapy for dry AMD patients in the U.S.,” stated Clark Tedford, PhD, President and CEO. “We are excited to have the NIH/NEI partially support the further development endeavors of LumiThera, and the grant is a significant step in the validation of the PBM technology and its potential in treating chronic eye disease.”
“We are very excited to be part of the LIGHTSITE US multicenter trial,” said Richard Rosen, MD, New York Eye and Ear Infirmary of Mount Sinai. “Several major U.S. centers are participating in this trial, which should help substantiate the clinical benefits of this therapy, reported to date. This trial will measure a variety of clinical and pathological outcomes and establish the long-term benefits of PBM for dry AMD patients.”