LumiThera has announced a definitive merger agreement with Diopsys, a manufacturer of advanced visual electrophysiological medical devices that assist eye care specialists in analyzing the complete visual pathway for visual and neuro-visual disorders.
Diopsys’ stockholders will receive LumiThera shares, and Diopsys will become a completely owned subsidiary of LumiThera, according to the terms of the agreement, which has been accepted by both companies’ stockholders.
The financial terms of the deal, which is scheduled to finalize in the coming months, were not disclosed.
Electroretinography (ERG) is a well-known diagnostic procedure that analyzes the electrical activity of the retina in response to a light stimulus.
As LumiThera enters the US market, Diopsys brings a well-established commercial sales force to the table, which when paired with LumiThera generates a broader worldwide footprint with a sizable ophthalmology/optometry customer base.
The LIGHTSITE III trial is still progressing, with a 13-month effectiveness timepoint for all participants expected in the first quarter of 2022.
LumiThera and Diospys revealed earlier this year that the ELECTROLIGHT pilot research in intermediate dry AMD patients had reached its final positive topline results.
The prospective clinical trial involved 23 eyes from 15 Dry AMD participants who were treated with PBM using the Valeda Light Delivery System (3 times per week for 3 weeks) and ERG function was assessed using 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," Joe Fontanetta, CEO, Diopsys, said in a company news release.
"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," said Clark E. Tedford, PhD, 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."