Results of dry AMD pilot study show promise

LumiThera Inc. has released the interim data from its ELECTROLIGHT pilot study in dry AMD patients.

The medical device company had 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.

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, MD, and Larry Perich, DO, at the Perich Eye Center in 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,” Dr. Montzka, said in a statement. “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).

Dr. Perich said the early study results were promising.

“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,” he said in a statement.

According to Joe Fontanetta, CEO, Diopsys, the 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.

“This study will allow us to examine ERG changes over time and may help with retreatment decisions,” he said in a statement.

Moreover, Clark E. Tedford, Ph.D., president and CEO of LumiThera, noted that the company maintains that the use of imaging and biomarkers are key in providing the physician the tools to fully optimize PBM treatments.

“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,” he concluded in a statement.