Trending...
- New Research Spotlight, Expanding TUSC2 Science & Strategic Development Milestones Put Gene Therapy Innovation into Focus for Genprex (NAS DAQ: GNPX)
- One in three Americans may have lost track of retirement savings from a previous job
- Tacoma: Statement from Emergency Response Leaders on Proposed Changes to Alternative Response
SEATTLE, July 21, 2021 /PRNewswire/ -- LumiThera Inc., a commercial stage medical device company offering a photobiomodulation (PBM) treatment for ocular damage and disease, today announced the final 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). Eight Caucasian males and seven females were enrolled with a mean age of 75.1 years (65-93 years). The mean time since AMD diagnosis was 5.0 years (0-14 years). 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. The study followed the patients out to 6 months. 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 showed a 9% improvement at 6 months in the 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 interim 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).
More on Washingtoner
"Valeda provided statistically significant and sustained improvements in BCVA, CS and multi-luminance ERG function from baseline out to Month 6 time point following 9 PBM treatments," stated Dan Montzka, M.D. "Diopsys multi-luminance ERG is an early, sensitive and quantitative measure of visual dysfunction in dry AMD patients."
"The study further confirms previous LIGHTSITE I and II studies that the Valeda Light Delivery System improves visual function," stated Larry Perich, D.O. "The subjects were very pleased with the results of their treatments and no safety issues were seen."
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. "These results of this work will allow physicians to diagnose, treat and monitor patients and provides physicians a solution for a disease with limited treatment options."
"We are strong supporters of treating degenerative disease early to slow the progression of vision-threatening disease." stated Clark E. Tedford, Ph.D., President and CEO, LumiThera, Inc. "The key in chronic ocular disease is early diagnosis, treatment and monitoring and we hope studies such as this pilot pave the way to a more preventative approach. The patients in the ELECTROLIGHT study are similar in demographics as the LIGHTSITE III US study in terms of time from dry AMD diagnosis, AREDs use and age. Previously, we reported the US LIGHTSITE III dry AMD trial fully enrolled 100 subjects in 1Q of 2021 and is continuing to move forward with the 13-month efficacy timepoint for all patients in 1Q of 2022."
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).
More on Washingtoner
About Diopsys
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 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.
2021 LumiThera, Inc., All rights reserved.
Related Links
http://www.lumithera.com
SOURCE LumiThera Inc.
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). Eight Caucasian males and seven females were enrolled with a mean age of 75.1 years (65-93 years). The mean time since AMD diagnosis was 5.0 years (0-14 years). 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. The study followed the patients out to 6 months. 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 showed a 9% improvement at 6 months in the 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 interim 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).
More on Washingtoner
- TradeJARnal Launches Innovative Trading Journal to Help Stock and Options Traders Build Discipline and Smarter Trading Habits
- Pursant Founder Mark Herbick Joins STS Capital Partners as CEO
- HiLine Homes' "Building Homes & Filling Plates" Food Drive Returns to Support Local Families
- Tampa Holiday Sessions: Captured by Mallary Opens 2026 Christmas Minis With Two New Sets
- Tampa Web Design Launches New Website for Entrepreneur and Capital Markets Advisor Martin Sumichrast
"Valeda provided statistically significant and sustained improvements in BCVA, CS and multi-luminance ERG function from baseline out to Month 6 time point following 9 PBM treatments," stated Dan Montzka, M.D. "Diopsys multi-luminance ERG is an early, sensitive and quantitative measure of visual dysfunction in dry AMD patients."
"The study further confirms previous LIGHTSITE I and II studies that the Valeda Light Delivery System improves visual function," stated Larry Perich, D.O. "The subjects were very pleased with the results of their treatments and no safety issues were seen."
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. "These results of this work will allow physicians to diagnose, treat and monitor patients and provides physicians a solution for a disease with limited treatment options."
"We are strong supporters of treating degenerative disease early to slow the progression of vision-threatening disease." stated Clark E. Tedford, Ph.D., President and CEO, LumiThera, Inc. "The key in chronic ocular disease is early diagnosis, treatment and monitoring and we hope studies such as this pilot pave the way to a more preventative approach. The patients in the ELECTROLIGHT study are similar in demographics as the LIGHTSITE III US study in terms of time from dry AMD diagnosis, AREDs use and age. Previously, we reported the US LIGHTSITE III dry AMD trial fully enrolled 100 subjects in 1Q of 2021 and is continuing to move forward with the 13-month efficacy timepoint for all patients in 1Q of 2022."
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).
More on Washingtoner
- Miami Dade College and World Affairs Council of Miami announce Navarro-Cabrera scholarship
- RPP to host first Professional Padel Week in Miami and announce the 2026 USA Awards winners
- UK Financial Ltd. Announces Maya Preferred PRA as First Fully Verified Asset on MAYA CHAIN; Chainlink Proof of Reserve Integration Planned for Network
- ALight Technology And Services Limited Advances Through Peachscore + Dealum Accelerator and Join LvlUp Labs
- International Misophonia Foundation Launches Sensory Accessible Technology Initiative to Address Overlooked Digital Accessibility Barriers
About Diopsys
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 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.
2021 LumiThera, Inc., All rights reserved.
Related Links
http://www.lumithera.com
SOURCE LumiThera Inc.
0 Comments
Latest on Washingtoner
- Unlocking the Next Phase of Growth with New AI Innovations; Targeting 2027 as Breakeven; Revenue Momentum Accelerates: ZenaTech (N A S D A Q: ZENA)
- AeroNet Deploys netElastic vBNG and CGNAT with Tarana Wireless to Deliver Scalable, Fiber-Class Broadband Across Puerto Rico
- New Atlas Maps the 38 States Behind Every Conversation
- Atlanta Company Launches Free, Ad-Free, Nonpartisan Voter Planning App for All 50 States Ahead of the Nov. 3 Election
- NECP Promotes Chertova to Senior Business Analyst
- Security Industry Veteran Anthony Rumore Launches AegisLead to Help Security Companies Find Business and Manage Growth
- Charlie Shaw and Patrick Carragher win SEO Agency of the Year 2026
- Canadian Woman Plants 1,667 Love Stories in a Field of Peonies That Could Bloom for 100 Years
- New Research Spotlight, Expanding TUSC2 Science & Strategic Development Milestones Put Gene Therapy Innovation into Focus for Genprex (NAS DAQ: GNPX)
- Proform Builds Releases Short Documentary on Founder Joey Fentress and the Story Behind the Company
- Tacoma City Council Passes Ordinance to Modernize Property Maintenance Standards, Address Repeat and Chronic Violations, and Strengthen Neighborhood Livability
- Spokane: SPD are Searching for a Vehicle in Connection with Fatal Hit and Run
- Are the Cameras in Spokane Flock or ALPRs?
- Tacoma: Statement from Emergency Response Leaders on Proposed Changes to Alternative Response
- Access Control Security Shares 5 Ways Retailers Can Prevent Holiday Theft
- Extreme Lead Program Highlights $27 Real Human Traffic Test for Affiliate and Network Marketers
- Call 311 for Non-Emergency Help in City of Spokane Limits
- Paraguay Expedition Offers a Different View of Human Resilience
- Longevity Academy Features Gail Humble, MD of KLOTHO SKIN in the Longevity Leaders Project
- Datavalet Named One of Quebec's Best Workplaces™ for 2026