LumiThera Announces US LIGHTSITE III Clinical Trial Meets Primary Efficacy Endpoint in Improving Vision in Dry Age-Related Macular Degeneration Subjects

SEATTLE, March 22, 2022 /PRNewswire/ -- LumiThera Inc., a commercial stage medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced positive findings in its LIGHTSITE III, multi-center clinical trial in non-neovascular (dry) Age-Related Macular Degeneration (AMD) subjects treated with the Valeda^® Light Delivery System.

The LIGHTSITE III, a prospective, double-masked, randomized, multi-center clinical trial, was conducted at ten leading US retinal centers. The objective was to treat dry AMD subjects with PBM every four months for a duration of 24 months. The primary efficacy endpoint, best corrected visual acuity (BCVA) was evaluated at 13 months, and if statistically significant, (p < 0.025) the complete 13-month efficacy and safety endpoints would be unmasked. The study will continue to treat and follow subjects for safety for a total 24 months. One hundred subjects were enrolled in a 2:1 ratio of PBM to sham in the treatment groups. The mean age was 75 years and mean dry AMD duration was 4.9 years before enrollment in the study. 

The analysis included 91 eyes in the PBM treatment group and 54 eyes in the sham-treatment group in the modified intent to treat population with at least 1 post-treatment visit and disease consistent with intermediate dry AMD. The results demonstrated statistically significant improvement in the primary endpoint in BCVA at 13 months in the PBM treatment group over the sham-treatment group (p < 0.003). In addition, a sustained, mean increase in ETDRS letter score of 5.5 letters from baseline was seen at the 13-month timepoint in the PBM-treated subjects BCVA (p < 0.0001).

"Previously, LIGHTSITE II European trial results demonstrated similar sustained improvements of visual benefits with PBM treatments at this interval out to 9 months," stated René Rückert, MD, MBA, Chief Medical Officer, LumiThera. "We have been treating dry AMD patients for multiple years in Europe now with many US patients traveling to EU and UK sites to access treatment.   The mean 5.5 letter improvement was outstanding considering the earlier stage of disease in these patients. We are excited to potentially offer this to US patients in the near future."

"These early results from the LIGHTSITE III trial are indeed very encouraging," said Diana V. Do, MD and Quan Dong Nguyen, MD, MSc, both are professors of ophthalmology and members of the Retina Division at the Byers Eye Institute at Stanford University, which is one of the clinical sites for the LIGHTSITE trial. "We are in urgent need of therapy for our patients with dry AMD, especially if the treatment is non-invasive such as the Valeda Light Delivery System.  Photobiomodulation has the potential to be an exciting treatment option for dry AMD patients."

"The trial results suggest a very strong clinical outcome signal. As the full analysis of additional endpoints and imaging results become available over the next few weeks, we anticipate further positive findings" remarked Cindy Croissant, MBA, VP, Clinical Operations. "Patient compliance remained high over the course of the study demonstrating the ease of administering Valeda's ~4 min treatment per eye and flexible scheduling."

"This is an exciting outcome for dry AMD patients experiencing vision loss who currently have limited treatment options. PBM can offer non-invasive treatment that can improve vision," stated Clark Tedford, Ph.D., President and CEO. "Consideration should be given to the application of PBM earlier in the degenerative disease process and prior to permanent retinal tissue and vision loss to demonstrate if PBM may prevent or slow degenerative eye disease."

The initial, first presentation worldwide of the top line data will be presented at the 2022 Sonoma Eye Meeting (Sonoma, California) by one of the LIGHTSITE III study investigators, Dr. Diana V. Do, Byers Eye Institute, Stanford University on Friday, March 25, 2022.

About AMD

AMD is a leading cause of vision loss for people aged 65 and older.  Losing central vision can make it harder to see faces, drive, or do close-up work like cooking or fixing things around the house.  The overall prevalence of AMD is estimated to increase 7-fold with age, from 4.2% in those aged 45–49 years, to 27.2% in those aged 80–85 years. Globally, the prevalence is estimated to increase by 20% between 2020 (195.6 million) and 2030 (243.3 million).

About LumiThera

LumiThera is a commercial-stage medical device company focused on treating people affected by ocular damage and disease 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 visual disorders. The company is commercializing the office-based Valeda^® Light Delivery System to be used by eyecare providers 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 also available in select countries in Latin America. Valeda is not approved for use by the Food & Drug Administration (FDA) in the USA.

LumiThera recently acquired Diopsys, Inc. to further offer diagnostic and monitoring capabilities to eyecare specialists. Diopsys is a leader in modern visual electrophysiology medical devices that help eye care professionals analyze the entire visual pathway for visual and neuro-visual disorders. The company provides both Visual Evoked Potential (VEP) and ERG vision testing technology. It is this technology that powers Diopsys, Inc.'s medical devices – the Diopsys^® NOVA^™, Diopsys^® ARGOS^™, and Diopsys^® RETINA PLUS^™ ERG and VEP Vision Testing System product series and the Enfant^® Pediatric VEP Vision Testing System.

Visit the Company's website at www.lumithera.com.

2022 LumiThera, Inc., All rights reserved.

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