LumiThera Inc., a commercial stage medical device company creating a photobiomodulation (PBM) treatment for ocular disorders and disease, today announced it is a recipient of a small business innovative research (SBIR) phase II grant from the National Institute of Health (NIH) and the division of the National Eye Institute (NEI).

The phase II grant supports a prospective, randomized, multi-center human clinical trial in U.S. subjects diagnosed with dry age-related macular degeneration (dry AMD.)  The LIGHTSITE III 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 two 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 II) 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,” commented Quan Dong Nguyen, M.D., M.Sc. and Diana V. Do, M.D., both professors of ophthalmology at the Byers Eye Institute, Stanford University School of Medicine. “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 II and III 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,” stated David Boyer, MD., Retina-Vitreous Associates Medical Group, Los Angeles, CA. “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, Ph.D., 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 U.S. multicenter trial.” remarked Richard Rosen, M.D., 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.”

About LumiThera Inc.

LumiThera is a commercial-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 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 Union only. Valeda™ is not approved for use by the Food & Drug Administration (FDA) in the USA.