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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."
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"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."
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"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."
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"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."
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"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
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