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 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 most common diabetic eye disease and a leading cause of blindness in American adults.  It is caused by damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina). At first, DR may cause no symptoms or only mild vision problems, but eventually, it can lead to blindness. Diabetic retinopathy can develop in anyone who has type 1 or type 2 diabetes. The longer a patient has diabetes and the less controlled their blood sugar is, the more likely they are to develop this eye complication. Sometimes the central part of the retina (macula) begins to swell (macular edema), a condition called DME that requires treatment.

“Diabetic retinopathy is the leading cause of blindness worldwide,” 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. “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,” stated David Boyer, M.D., Retina-Vitreous Associates Medical Group, Los Angeles, CA. “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, Ph.D., 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.”

“We are very excited to be part of the PRIME multicenter DME pilot trial,” remarked Victor Gonzalez, M.D., Valley Retina Institute, McAllen, Texas. “The U.S. centers and investigators participating in this trial are very well experienced in the treatment of DME and this clinical trial will evaluate a variety of vision and imaging outcomes including Ocumet’s mitochondrial and Diopsys’ electroretinogram (ERG) functional measures with PBM and set the foundation for expanded use of Valeda in Diabetic Retinopathy and Macular Edema.”

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.

Source: Company Press Release