Trending...
- Heritage at South Brunswick Introduces New Ferndale Floorplan: The Largest Single-Family Home Design in the Community - 235
- Spokane: SPD Arrest Level III Registered Sex Offender for Failure to Register
- Spokane Police Respond to Overnight Shooting in Garland District
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
- Fit Body Boot Camp Launches Nationwide 'Fit Body Forever' Workshops to Help Adults 60+ Rebuild Strength and Prevent Falls
- Canadian Aerospace Defence Talent Expo (CADTE) Launches National TalentThread Initiative to Strengthen Canada's Future Workforce
- 5.6 Million EUR in Q1 Project Awards for Integrated IoT Solutions / Data Analytics Subsidiary of Smart City Developer: Affluence (Stock Symbol: AFFU)
- Merger Advancement For Embodied AI Co in Robotic Systems Serving High Value Hospitality, Gaming & Real Estate Sectors: MBody AI Corp. (NAS DAQ: MBAI)
- Hollywood In Pixels Announces Honorees for The 9th Silver PIXel Awards
"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
- New Research Finds a Good Deal Is All It Takes to Get Americans Booking a Last-Minute Vacation — and Most Already Have One on Their Mind
- GitKraken Introduces GitLens 19, Bringing Human and AI Workflows Together in One Workbench
- LĪNA Universal Balm Nominated for "Best Clean Skincare Product" at CertClean Beauty Awards
- Spokane: SPD Arrest Level III Registered Sex Offender for Failure to Register
- SPD Detectives Investigating Suspicious Deaths in Northeast Spokane
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
- Tickeron Highlights AI Trading Agent Performance Across Multiple Market Sectors
- Stop Bleeding Cash on Mediocre Talent. Build a Powerhouse Remote Team Instead
- Crownlight Strategies® Announces Federal Trademark Registration
- Spokane: PPE Available to Those Returning Home After New Evacuation Downgrades
- Spokane Police Respond to a Vehicle vs. Pedestrian
- New Book Calls 'Sense of Belonging' the Missing Link in Student Success
- Tacoma City Council Set to Join Pierce County's Efforts to Launch Unified Regional Approach to Reduce Homelessness
- Igbozue Connecticut USA Celebrates 2026 Summer Family Picnic
- KT Medical Staffing Addresses the Questions Families Forget to Ask Before Bringing Private Nursing Care Home
- Private Autopsies Give Arizona Families Answers After Nursing Home and Care Facility Deaths
- OPUS Global Data Solutions Launches Food Trader Plus, Bringing Operational Control and Deal-Level Profit Visibility to Food Brokers
- Phinge CEO DeMaio Unveils Speech to Congress: User Data Sovereignty vs Tech Surveillance Capitalism, Asserting Foundational 2021 App-Less Patents & IP
- Michael Maertens Hired as Century Fasteners Corp. – Chief Financial Officer
- Built to Last: Why BSI Is Among the Nation's Fastest-Growing Companies, and One of Its Best Places to Work
- Bent Danholm's The Architecture of Demand Reaches No. 2 in Amazon Real Estate Sales
- Contracting Resources Group Named to Inc. 5000 for the Ninth Time
- ImagineX Named to 2026 Inc. 5000 List of America's Fastest-Growing Private Companies
- ASSIST Software Becomes One of the First European Companies Certified to ISO/IEC 42001
- The World's No.1 Superstar® Enters the Occult with New Track and Cinematic Visual "Under Your Spell"
- PricZone Launches Online Shopping Platform Offering Electronics, Gaming, and More