LIGHTSITE IIIB: Clinical Evaluation of Photobiomodulation (PBM) in dry AMD Patients

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ABSTRACT As the population continues to age, degenerative ocular diseases become increasingly common and create tremendous burden on the health care system. Age-related macular degeneration (AMD) is a progressive ocular disease that causes visual impairment and blindness in its most advanced form and is characterized by loss of function and cell death in the macula, a central and critical part of the retina. Approximately 11 million individuals are affected with AMD in the United States alone, with a global prevalence of 170 million. AMD is the leading cause of visual disability in the developed world and the third leading cause globally. AMD occurs in two forms: dry and wet AMD. Approximately 85-90% of AMD patients have the “dry” form of the disease. Photobiomodulation (PBM) is a low-level light therapy used to induce beneficial cellular processes resulting in significant clinical outcomes, including tissue repair, tissue regeneration and anti- inflammatory effects. At the cellular level, the mechanisms of PBM are ascribed to activation of mitochondrial respiratory chain components resulting in stabilization of metabolic function. LumiThera, Inc. has developed the Valeda® Light Delivery System which delivers multiwavelength PBM for ocular indications. Multiple studies with Valeda now demonstrated improvements in quality of life, clinical, and anatomical outcomes in dry AMD patients. Topline data from the pivotal LIGHTSITE III study (148 eyes; 24-month study design) has met the primary efficacy endpoint demonstrating a statistically significant benefit between PBM and Sham treatment groups, p = 0.003. In addition, a mean 5.5 letter change increase from baseline in visual acuity was seen in the PBM treatment group, P < 0.0001. The current SBIR phase IIB application is to extend the findings from previous SBIR phase I and II studies (SBIR 1R43EY025508-01 and SBIR 1R43EY025508-03) to conduct an open-label, prospective, multi-center extension study in patients that are exiting the main LIGHTSITE III study. The extension will continue to assess the long-term PBM impact on disease progression, safety, and efficacy in subjects with dry AMD (LIGHTSITE IIIB) using Valeda. The study will also be able to compare and establish PBM benefits of early treatment versus delayed treatment by allowing extended PBM treatment for 3 years or starting PBM treatment after 2 years of sham treatment. Specific Aims will establish the magnitude of clinical and anatomical outcome benefits in a longitudinal magnitude for the first time. The grant supports a novel non-invasive, non- pharmaceutical, cost-effective therapy for Dry AMD.