Trending...
- Ritz-Carlton Residences Houston Generates Strong Early New Construction Sales at 2120 Post Oak Blvd
- Flexible Plan Investments Names Carl Resnick President
- Longevity Leaders Project to Feature Hunter Ziesing of Global Health Atlas
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
- Project CIVICA Report Finds 10,680 Non-Citizen Indicators on New York Voter Rolls — Including 88 Records with Recent Voting History
- New Analysis Details Three Converging Forces in AI and Workforce Policy Behind a $37 Billion GDP Reduction
- Revenue Optics Launches Pricing and Revenue Growth Management Practice, Names Shafohi Alamgir Vice President
- Popular AI planner Voiset launches version 2.0 and enters MENA at LEAP 2026 with full Arabic support
- Diginyze eCommerce ERP Module Creates Single Source of Truth for Enterprise Operations
"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
- CasaPerks and CredHub Partner to Help the Multifamily Industry Strengthen Resident Activation Through Credit-Building Rewards
- NaturismRE expands international research programme with Health & Wellbeing Survey
- Tacoma: Applications Now Being Accepted for a Position on the Planning Commission
- L2 Aviation and Gotonomi Extend UAV Connectivity Beyond Cellular Reach
- Tacoma: Hylebos Bridge Closed Today for Maintenance Work
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
- SPD Detectives are Investigating a Suspicious Death in West Spokane
- LCC Asia Pacific Sponsors CubeSatPlus 2026 at UNSW Sydney
- Spokane: City Council Approves Mayor's Orders for Declaration of Emergency
- Real Estate Syndication Attorney Tilden Moschetti Releases The Real Estate Private Equity Blueprint
- 5X Gross Margin Improvement to Beat EPS Consensus; $54.6 Million 10-Year Contract Award Puts Cybersecurity Leader on Path to a $30 Million Run Rate
- Independent Colbert Packaging Thrives Amid Industrywide Consolidation
- Free Commercial Glass Estimating and Code Compliance Tools Launched by Landmark Construction - The Leading Glass Company in Los Angeles
- Tallahassee Million-Dollar Home Sales Rise in 2026 as Median Selling Time More Than Doubles
- Longevity Leaders Project to Feature Hunter Ziesing of Global Health Atlas
- Spokane: SPD Arrest Male Suspected of Burglarizing Home in the Evacuation Zone
- Tacoma: Update Third Homicide Arrest – 2100 block of N 30th St
- Slotozilla Reports Strong Growth in Q2 2026
- Why U.S. Enterprises Are Replacing Fragmented eCommerce Stacks with AI Driven Platform Like Diginyze
- Flexible Plan Investments Names Carl Resnick President
- Tacoma: Statement by Council Member John Hines Celebrating Community Engagement on North Union Avenue Greenway Historic Designation
- Visit Spokane, City of Spokane Partner to Attract Film Production and Drive Economic Development
- Spokane: Public Service Announcement
- Tacoma Police Department Launches Tacoma Public Safety Partnership
- Paula Josephine Sadler Releases "Imagine" on 24th Anniversary of Sobriety
- Ritz-Carlton Residences Houston Generates Strong Early New Construction Sales at 2120 Post Oak Blvd