LumiThera announced 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 diabetic retinopathy (DR) and diabetic macular edema (DME). The Photobiomodulation Reduction In Macular Edema (PRIME) 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 6 months. In 2018, LumiThera obtained a CE mark to commercialize the Valeda Light Delivery System in Europe for the treatment of dry AMD.
“Diabetic retinopathy is the leading cause of blindness worldwide,” 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. “We will be evaluating if PBM can provide an early treatment for DR and reduce macular edema. If successful, PBM could delay or reduce the need for intravitreal pharmacotherapy with currently approved Anti-VEGF medications or replace invasive laser surgery.”
“The PRIME study expands LumiThera’s global efforts to bring forward PBM treatments for debilitating eye diseases that can result in loss of vision,” David Boyer, MD, Retina-Vitreous Associates Medical Group, Los Angeles, said in a company news release. “The PRIME study in DME patients would create a novel treatment option for DME patients and expand the Valeda use into a 2nd major therapeutic market.”
“The NIH clinical grant is substantial in providing over $1.5M in funding to develop a PBM therapy for diabetic patients in the U.S.,” stated Clark Tedford, PhD, President and CEO. “We are pleased 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.”
The Coordinating Center for the PRIME Study will be at the Byers Eye Institute at Stanford. The Ocular Imaging Research and Reading Center (OIRRC, Sunnyvale, CA) will serve as the Reading Center for the study.