LumiThera Inc., a commercial stage medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced its entry into a definitive merger agreement with Diopsys, Inc., a leader in modern visual electrophysiology medical devices that help eye care professionals analyze the entire visual pathway for visual and neuro-visual disorders. Under the terms of the agreement, which has been approved by both the stockholders of LumiThera and Diopsys, Diopsys stockholders will receive stock in LumiThera, and Diopsys will become a wholly owned subsidiary of LumiThera. The transaction is expected to close in the next few months.
The acquisition should provide a complementary diagnosis and monitoring platform to LumiThera’s leading treatment platform using Photobiomodulation (PBM) for ocular disease and damage. Electroretinography (ERG) is an established diagnostic test that measures the electrical activity of the retina of the eye in response to a light stimulus. Diopsys brings an established commercial U.S. sales force, and when combined with LumiThera creates a larger global footprint with a significant ophthalmology/optometry customer base as LumiThera approaches the U.S. market. Previously, LumiThera reported the U.S. LIGHTSITE III dry Age-related Macular Degeneration (AMD) trial fully enrolled 100 subjects in 1Q of 2021. The LIGHTSITE III trial is continuing to move forward with the 13-month efficacy timepoint for all patients anticipated in 1Q of 2022.
Earlier this year, LumiThera and Diospys announced final positive topline data from the ELECTROLIGHT pilot study in intermediate dry AMD patients. A total of 23 eyes from 15 subjects with Dry AMD were enrolled into the prospective clinical study and treated with PBM using the Valeda Light Delivery System (3 times per week for 3 weeks) and ERG function was evaluated with the Diospys NOVA ERG system. Multi-luminance ERG improved by 14.4% from baseline (BL) after completion of the Month 1 treatment and showed a 9% improvement at 6 months in the intent to treat (ITT) population. A positive correlation between multi-luminance ERG and best corrected visual acuity (BCVA) was seen (p < 0.05) following initial PBM treatment. Positive correlations between multi-luminance ERG and fixed luminance (R = 0.870) and chromatic ERG outcomes (R = 0.676) were also reported in the Month 1 analysis. Subjects showed approximately 12.8 ± 0.98 letter improvement in BCVA at Month 6 compared to BL scores. Mars Contrast Sensitivity (CS) also showed improvement from BL to Month 6 at 40 cm (0.202 log + 0.02), 80 cm (0.197 log + 0.02) and 120 cm (0.28 log + 0.03). "Diopsys ERG testing is a powerful and quantitative diagnostic that can be coupled with LumiThera's PBM treatments to characterize early patient benefits on visual function," indicated Joe Fontanetta, CEO, Diopsys. "The theranostic company will be able to provide the tools physicians need to diagnose, treat and monitor patients and provides physicians a solution for multiple ocular diseases with limited treatment options." "We are strong believers of treating degenerative disease early to slow the progression of vision-threatening disease. The synergy of these technologies makes sense on many levels and could optimize Valeda treatments," stated Clark E. Tedford, Ph.D., President and CEO, LumiThera, Inc. "The key in chronic ocular disease is early diagnosis, treatment and monitoring. We believe using light-based devices, we can create a unified approach to diagnose, treat and follow patients. This may further pave the way to a more preventative approach to vision loss and a path to optimize and create a machine learning approach to individualize ocular therapy." About AMD AMD is a leading cause of vision loss for people age 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).
Diopsys, Inc. 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.
About LumiThera Inc.
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 not approved for use by the Food & Drug Administration (FDA) in the USA.