Trending...
- Registered Nurse Launches Healthcare Wealth Strategy Practice for Healthcare Professionals
- SelfCare is now HealthCare across America
- UK Financial Ltd Tokenized LTNS 1, A $1.1 T Asset-Backed ERC-3643 Security Token with 11 On-Chain Contracts Verifying, Compliant Real-World Value
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
- Architect of Neurodiversity Will Lead the First U.S. Team of Autistic Children to the "Genius Cup" in Hiroshima, Japan, in 2027
- Foiling Freaks Launches New Online Platform Dedicated to Foiling Board Sports
- Deborah E. Jones Introduces Emotional Sovereignty, a Powerful New Book on Emotional Mastery, Resilience, and Intentional Living
- New Research Identifies "The Busy Effect": 89% of Americans Want a Laid-Back Vacation — Only 15% Actually Achieve It
- Alchemy 43 Appoints Shane Smith as CEO to Drive Operational Performance and Scalable Growth
"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
- Best Spiritual Healing, Meditation & Retreats in Sedona — Rise Meditation Helps You Find and Book Transformational Experiences
- City of Tacoma Recognized for 39th Consecutive Year with Highest Honor in Governmental Financial Reporting
- Tacoma: City to Conduct Essential Asphalt Repairs on Proctor Street April 6 – 10
- $16 Billion Market by 2034 in Underwater Drones Presents Huge Opportunity for AI-Powered Autonomous Vehicle Serving Defense & Commercial Customers
- Appliance EMT Named Among Jacksonville's Top 3 Appliance Repair Companies by ThreeBestRated®
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
- L2 Aviation Earns FAA STC for Thales AVIATOR 200S for Boeing 777
- Women-Owned Business Platform SmartPath Launches to Help Entrepreneurs Build with Confidence
- FinIQ Edu Launches High-Impact Workshop Vertical to Close the Workplace Benefits Gap—Drives 82% Surge in 401(k) Participation Intent
- HousingWire launches Mortgage Rankings, bringing a data-driven benchmark to originator performance
- J&J Exterminating Reminds Residents to prepare for Termite Swarm Season
- City of Spokane Celebrates Return of Spokane Gives
- Registered Nurse Launches Healthcare Wealth Strategy Practice for Healthcare Professionals
- Just 1 in 57 Crypto Owners Globally Pay Taxes on Their Holdings, New Report Finds
- IQSTEL accelerates toward profitability inflection with $317M revenue and AI-driven expansion; IQSTEL Inc. (N A S D A Q: IQST) i
- AI-Driven Breakthrough Unleashed: Bionic Intelligence Platform Goes Live to Capture Massive Biotech Opportunity: KALA BIO, Inc. (N A S D A Q: KALA)
- Surging Into Hyper-Growth Mode With Record Revenue, Raised 2026 Guidance, and Game-Changing AI Platform; Off The Hook YS (NYSE American: OTH)
- Mom Creators Coalition Launches with WaterWipes® as Official Founding Sponsor
- Middle World Herbs Expands Botanical Skincare with a Unique Herbal Deodorant
- PandaGuarantee Launches Rent Guarantor Service in New York City
- The $112M Marketing Lesson Joe Whyte Learned: Why 'More Traffic' Is the Biggest Lie in Digital Marketing
- Daniel Kaufman Expands Kaufman & Company Real Estate Platform With New Acquisitions, AI-Driven Industrial Development and Nationwide Growth Initiative
- Tacoma City Council Member Kristina Walker to Share Sound Transit Updates During March 31 Study Session
- Peony Massage Spa Kirkland Offers 50% Off First Visit – Licensed ABMP Member Serving Kirkland, Redmond & Bellevue
- purelyIV Launches Lab Testing Services in Metro Detroit
- Spokane Police Arrest Two At Saturday's Protest