Trending...
- Spokane: Flags Lowered for the Victims of the Longview Tragedy
- A Statement from Pierce County Executive Ryan Mello and Tacoma City Council Member Kristina Walker on Vote Regarding Sound Transit 3 Long-Range Financial Plan
- Tacoma: OMWBE Certification 201 Workshop on May 28
SEATTLE, April 7, 2021 /PRNewswire/ -- LumiThera Inc., a commercial stage medical device company delivering photobiomodulation (PBM) treatment for ocular disorders and disease, today announced positive findings in its LIGHTSITE II, multi-center clinical trial in dry Age-Related Macular Degeneration (AMD) patients.
The prospective, double-masked, randomized, multi-center, European Union post-marketing clinical trial, titled LIGHTSITE II, was conducted in eight leading retinal centers based in the United Kingdom, Germany, Spain, Italy and France. The objective was to treat dry AMD subjects over the course of three rounds of PBM sessions every four months with a duration of 10 months. The study was converted to a smaller pilot as some of the enrolled subjects missed planned treatments due to COVID-19. Forty-four subjects were enrolled in a 2:1 ratio of PBM:Sham in the treatment groups. The mean age of the subjects was 74.1 years and mean dry AMD duration was 3.7 years after diagnosis.
The analysis included 32 eyes in the PBM group and 19 eyes in the sham-treatment group in the modified intent to treat group with at least 1 post-treatment visit and disease consistent with intermediate dry AMD. The results demonstrated a statistically significant improvement in the primary endpoint of best corrected visual acuity (BCVA) at 9 months from baseline (p < 0.02) in PBM-treated subjects. No safety issues were identified following 3 rounds of PBM treatment given at 4-month intervals.
In a separate analysis to minimize the impact of COVID-19, subjects that completed all 27 per protocol planned PBM treatment visits were evaluated. A statistically significant improvement in BCVA at 9 months from baseline (p = 0.01) in PBM-treated subjects was also seen. The mean vision benefit for the PBM group versus Sham-treated group at 9 months was approximately 4 letters versus a 0.5 letter gain in the Sham-treatment group and was trending towards significance (p = 0.1).
"Results showed a steady improvement over time in BCVA measurements from baseline with the shortened PBM treatment intervals," stated René Ruckert, MD, Chief Medical Officer, LumiThera. "Previously, LIGHTSITE I study results demonstrated some remission of visual benefits between PBM treatments delivered every six months. The benefits of four-month treatment intervals were more consistent in maintaining vision outcomes."
More on Washingtoner
"The data demonstrated that 35% of the PBM-treated subjects that completed all visits had a >5 letter improvement in the standard eyechart, which was over twice the % of subjects in the Sham-treated group," stated Ignasi Jürgens, MD, PhD, Medical Director of the Institut Catala de Retina and Professor of Ophthalmology, Universitat Internacional de Catalunya, Barcelona, Spain. "These improvements in vision in dry AMD subjects by Valeda treatments can have a positive impact on their quality of life."
"LIGHTSITE II specifically targeted preventive treatment in earlier stage dry AMD patients and excluded advanced, late-stage dry AMD patients with central 1 mm involving geographic atrophy (GA)," noted Prof. Marion Munk, MD, PhD, Bern Photographic Reading Center. "Drusen volume measured by OCT showed increases in the sham-treated subjects over time and no growth in the PBM-treated group but did not reach statistical significance due to the limited study size. Moreover, the growth rate of geographic atrophy (GA) in the sham-treated group was consistent as seen in published literature studies. PBM-treated subjects showed a decrease in GA growth by 44% at 10 months. The study also included a high 36.4% of subjects (16/44) with high-risk eyes wherein the fellow eye had exudative (wet) macular neovascularization. None of the high-risk study eyes converted to wet in the PBM-Treatment group (0/12 subjects). The overall conversion from dry to the wet form of AMD was lower at 3.1% for the PBM-treated group versus 5.6% in the Sham-treated and 4.8% in the non-study eyes. These beneficial findings have to be confirmed by larger studies."
"We made the decision not to fully reopen enrollment in LIGHTSITE II to protect subjects and the integrity of the study from an anticipated Fall spike in COVID-19 cases.," remarked Cindy Croissant, VP, Clinical Operations. "Enrolled subjects were allowed to complete the study after it was safe to return, LumiThera was then able to evaluate the safety and efficacy of PBM in this earlier stage population of dry AMD patients."
More on Washingtoner
"The data strongly suggests that the Valeda Light Delivery System can provide a safe, non-invasive treatment opportunity for dry AMD patients with limited options," stated Professor Ben Burton, MD, James Paget University Hospital. "The earlier stage subjects in the study averaged impaired vision between 20/32 and 20/40, so being able to prevent further vision loss and potentially slowing the progression of disease would be a huge benefit for patients."
"We continue to optimize Valeda treatments from knowledge gained in the LIGHTSITE II study as well as the recent ELECTROLIGHT study," stated Clark Tedford, Ph.D., President and CEO. The European Union post-marketing study is valuable as it demonstrates safety for three Valeda treatment sessions per year and more stable vision benefits and further establishes potential disease-modifying benefits on anatomical endpoints including GA growth in these earlier patients. We anticipate these findings will be further established in the fully enrolled LIGHTSITE III U.S. trial."
In 2018, LumiThera obtained a CE mark to commercialize the Valeda Light Delivery System in the European Union for the treatment of dry AMD. LIGHTSITE III, a companion U.S. trial has recently completed enrollment with 100 patients and is an FDA-approved study to support approval in the U.S.
Visit the Company's website at www.lumithera.com.
About LumiThera Inc.
LumiThera is a commercial-stage medical device company focused on treating people affected by ocular disorders and diseases 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 acute and chronic ocular diseases and disorders. The company is developing 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.
©2021 LumiThera, Inc., All rights reserved.
SOURCE LumiThera Inc.
Related Links
http://www.lumithera.com
The prospective, double-masked, randomized, multi-center, European Union post-marketing clinical trial, titled LIGHTSITE II, was conducted in eight leading retinal centers based in the United Kingdom, Germany, Spain, Italy and France. The objective was to treat dry AMD subjects over the course of three rounds of PBM sessions every four months with a duration of 10 months. The study was converted to a smaller pilot as some of the enrolled subjects missed planned treatments due to COVID-19. Forty-four subjects were enrolled in a 2:1 ratio of PBM:Sham in the treatment groups. The mean age of the subjects was 74.1 years and mean dry AMD duration was 3.7 years after diagnosis.
The analysis included 32 eyes in the PBM group and 19 eyes in the sham-treatment group in the modified intent to treat group with at least 1 post-treatment visit and disease consistent with intermediate dry AMD. The results demonstrated a statistically significant improvement in the primary endpoint of best corrected visual acuity (BCVA) at 9 months from baseline (p < 0.02) in PBM-treated subjects. No safety issues were identified following 3 rounds of PBM treatment given at 4-month intervals.
In a separate analysis to minimize the impact of COVID-19, subjects that completed all 27 per protocol planned PBM treatment visits were evaluated. A statistically significant improvement in BCVA at 9 months from baseline (p = 0.01) in PBM-treated subjects was also seen. The mean vision benefit for the PBM group versus Sham-treated group at 9 months was approximately 4 letters versus a 0.5 letter gain in the Sham-treatment group and was trending towards significance (p = 0.1).
"Results showed a steady improvement over time in BCVA measurements from baseline with the shortened PBM treatment intervals," stated René Ruckert, MD, Chief Medical Officer, LumiThera. "Previously, LIGHTSITE I study results demonstrated some remission of visual benefits between PBM treatments delivered every six months. The benefits of four-month treatment intervals were more consistent in maintaining vision outcomes."
More on Washingtoner
- 2026 Editorial Freelancers Association Conference Focuses on Building Sustainable Careers
- netElastic Powers LigaT's High-Performance Broadband Expansion and IPv6 Modernization in Portugal
- Raiku launches rkuSOL with Sanctum, Kamino, Loopscale and Exponent
- Greenland Mines Ltd (N A S D A Q: GRML) Advances Strategic Growth Initiatives as Critical Minerals Demand Accelerates
- Entering the $69 Billion Animal Health Market, Delivering Record Growth, AI-Driven Healthcare Innovation, and Targeting $200 Million Revenue by 2029
"The data demonstrated that 35% of the PBM-treated subjects that completed all visits had a >5 letter improvement in the standard eyechart, which was over twice the % of subjects in the Sham-treated group," stated Ignasi Jürgens, MD, PhD, Medical Director of the Institut Catala de Retina and Professor of Ophthalmology, Universitat Internacional de Catalunya, Barcelona, Spain. "These improvements in vision in dry AMD subjects by Valeda treatments can have a positive impact on their quality of life."
"LIGHTSITE II specifically targeted preventive treatment in earlier stage dry AMD patients and excluded advanced, late-stage dry AMD patients with central 1 mm involving geographic atrophy (GA)," noted Prof. Marion Munk, MD, PhD, Bern Photographic Reading Center. "Drusen volume measured by OCT showed increases in the sham-treated subjects over time and no growth in the PBM-treated group but did not reach statistical significance due to the limited study size. Moreover, the growth rate of geographic atrophy (GA) in the sham-treated group was consistent as seen in published literature studies. PBM-treated subjects showed a decrease in GA growth by 44% at 10 months. The study also included a high 36.4% of subjects (16/44) with high-risk eyes wherein the fellow eye had exudative (wet) macular neovascularization. None of the high-risk study eyes converted to wet in the PBM-Treatment group (0/12 subjects). The overall conversion from dry to the wet form of AMD was lower at 3.1% for the PBM-treated group versus 5.6% in the Sham-treated and 4.8% in the non-study eyes. These beneficial findings have to be confirmed by larger studies."
"We made the decision not to fully reopen enrollment in LIGHTSITE II to protect subjects and the integrity of the study from an anticipated Fall spike in COVID-19 cases.," remarked Cindy Croissant, VP, Clinical Operations. "Enrolled subjects were allowed to complete the study after it was safe to return, LumiThera was then able to evaluate the safety and efficacy of PBM in this earlier stage population of dry AMD patients."
More on Washingtoner
- $97.9 Million Q1 Revenue Growth Reinforces Transformation Into a Global AI & Digital Services Powerhouse: IQSTEL, Inc. (N A S D A Q: IQST)
- City of Tacoma Attracts More Affordable Housing to Proctor Neighborhood
- Tacoma: Homicide Investigation – 800 Block of Martin Luther King JR Way
- Spokane: Community Days At City Council Celebrating Student Civic Engagement
- Boston Industrial Solutions Launches Natron® 348 UV Inkjet Ink for Epson S3200 Print Heads
"The data strongly suggests that the Valeda Light Delivery System can provide a safe, non-invasive treatment opportunity for dry AMD patients with limited options," stated Professor Ben Burton, MD, James Paget University Hospital. "The earlier stage subjects in the study averaged impaired vision between 20/32 and 20/40, so being able to prevent further vision loss and potentially slowing the progression of disease would be a huge benefit for patients."
"We continue to optimize Valeda treatments from knowledge gained in the LIGHTSITE II study as well as the recent ELECTROLIGHT study," stated Clark Tedford, Ph.D., President and CEO. The European Union post-marketing study is valuable as it demonstrates safety for three Valeda treatment sessions per year and more stable vision benefits and further establishes potential disease-modifying benefits on anatomical endpoints including GA growth in these earlier patients. We anticipate these findings will be further established in the fully enrolled LIGHTSITE III U.S. trial."
In 2018, LumiThera obtained a CE mark to commercialize the Valeda Light Delivery System in the European Union for the treatment of dry AMD. LIGHTSITE III, a companion U.S. trial has recently completed enrollment with 100 patients and is an FDA-approved study to support approval in the U.S.
Visit the Company's website at www.lumithera.com.
About LumiThera Inc.
LumiThera is a commercial-stage medical device company focused on treating people affected by ocular disorders and diseases 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 acute and chronic ocular diseases and disorders. The company is developing 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.
©2021 LumiThera, Inc., All rights reserved.
SOURCE LumiThera Inc.
Related Links
http://www.lumithera.com
0 Comments
Latest on Washingtoner
- Community, Conservation & Waterwise Inspiration Bloom on June 6
- Industrial and systems engineers celebrate key leaders in the field at IISE Annual Conference
- Cosanostra Miami Rises as the Best Latin Nightclub in Miami in Under Two Years From its Opening
- CCHR Leader's 50-Year Fight for Psychiatric Drug Victims Gains National Momentum
- Author Releases 7-Day Screen Time Reset for Families as Teachers Worldwide Report Children "Struggling to Grasp Basic Concepts"
- Men's Health Month Begins with Record Proclamations, AP News Coverage, & National Momentum for Men's Health
- AdvisorVault Adds Social Media Archiving to its Consolidated D3P Service
- UK Financial Ltd Audits Full Ethereum Architecture Verifies Corporate Wallets and 19-Token Ecosystem Ahead of CoinMarketCap Filing for Global Ranking
- Spokane: Flags Lowered for the Victims of the Longview Tragedy
- Creative Investment Research Analysis Finds Slower GDP Growth, Rising Inflation
- Award-winning author Diana Colleen Explores Psychedelic Therapy, Climate Change and Billionaire-ism
- TechHouse Earns Highly Selective Microsoft Support Badge
- Spokane: Flags Lowered for Former State Legislator Sam Hunt
- J&J Exterminating Celebrates 65th Anniversary and Unveils Strategic Vision at Annual Team Meeting
- Tacoma: OMWBE Certification 201 Workshop on May 28
- Tru by Hilton El Paso Airport Opens to Guests
- Zenylitics Announces Leadership Transition to Continue Accelerated Growth
- A Statement from Pierce County Executive Ryan Mello and Tacoma City Council Member Kristina Walker on Vote Regarding Sound Transit 3 Long-Range Financial Plan
- Wellness Technology Distributor Helping People Set Up Wellness Center Businesses
- City to Establish Spokane Urban Native Advisory Council