A total of 23 eyes from 15 subjects with intermediate 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). Subjects were tested for safety and functional vision improvements using the Diopsys electroretinogram (ERG) device. ERG is a diagnostic test that measures the electrical activity of the retina of the eye in response to a light stimulus. All subjects were tested at weekly intervals for ERG function prior to the start of the next week of PBM treatments. An interim analysis was performed following the Month 1 study visit. The study was conducted by Dan Montzka, M.D. and Larry Perich, D.O. at the Perich Eye Center (New Port Richey, Florida).
Multi-luminance Electroretinogram (ERG) Magnitude AUC improved by 14.4% from baseline after completion of the Month 1 treatment, and this difference was determined to be significant (p = 0.001). A positive correlation between multi-luminance ERG and best corrected visual acuity (BCVA) was seen (p < 0.05). Positive correlations between multi-luminance ERG and fixed luminance (R = 0.870) and chromatic ERG outcomes (R = 0.676) were also observed. Subjects showed approximately 12.6 ± 1.25 letter improvement in BCVA at Month 1 compared to BL scores. Mars Contrast Sensitivity (CS) also showed improvement from BL to Month 1 at 40 cm (0.165 log + 0.25), 80 cm (0.134 log + 0.20) and 120 cm (0.22 log + 0.37).
"Valeda provided statistically significant improvements in BCVA, CS and multi-luminance ERG function from baseline at the Month 1 time point following 9 PBM treatments," stated Dan Montzka, M.D. "Diopsys multi-luminance ERG is an early and sensitive measure of visual dysfunction in dry AMD patients. The study demonstrates the Valeda Light Delivery System improves visual function."
AMD is a leading cause of vision loss for people age 65 and older. Losing your 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).
"These are exciting early study results," stated Larry Perich, D.O., Faculty, HCA/USF Ophthalmology residency program. "We will continue to follow ERG outcomes for 6 months and determine if ERG outcomes combined with PBM treatment could identify patient improvements, monitor progress and optimize retreatment."
Diopsys ERG testing as a diagnostic tool to work with LumiThera's PBM treatments provides the ability to characterize early patient benefits on visual function," indicated Joe Fontanetta, CEO, Diopsys. "This study will allow us to examine ERG changes over time and may help with retreatment decisions."
"LumiThera believes the use of imaging and biomarkers are key in providing the physician the tools to fully optimize PBM treatments," stated Clark E. Tedford, Ph.D., President and CEO, LumiThera, Inc. "The opportunity to treat chronic ocular disease early could provide disease modifying benefits and we want to couple Valeda PBM treatments with diagnostic and imaging modalities to help doctors diagnose, monitor and treat patients early and effectively."
About Diopsys
Diopsys, Inc. is the world 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 Electroretinography (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 eye care specialists 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.
Visit the Company's website at www.lumithera.com.
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| Company Name: LumiThera Inc.
Clark Tedford, 1-360-536-5119 Email Contact Web: http://www.lumithera.com |
