LumiThera Announces Sustained Vision Improvement for 24 months in Dry Age-Related Macular Degeneration Subjects from US LIGHTSITE III Clinical Trial Data
15.3.2023 14:17:00 EET | Business Wire | Press release
LumiThera Inc., a medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced the 24-month data from its LIGHTSITE III, multi-center clinical trial which demonstrated sustained vision improvement in dry Age-Related Macular Degeneration (AMD) subjects treated with the Valeda® Light Delivery System.
LIGHTSITE III, a prospective, double-masked, randomized, multi-center clinical trial, was conducted at ten leading US retinal centers and enrolled 100 subjects with early to intermediate dry AMD. Eyes were treated with the Valeda system every four months. The last treatment was administered at 21 months and the last follow-up visit was at 24 months. The primary efficacy endpoint was best corrected visual acuity (BCVA). At 24 months there were minimal safety risks and high patient compliance; 80% of the patients completed the trial. In the PBM-treated arm there was a statistically significant visual acuity improvement at month 21 following the last treatment with sustained vision benefits throughout the trial including the 24-month trial end.
The analysis included 91 eyes in the PBM treatment group and 54 eyes in the sham-treatment group in the modified intent to treat population with at least 1 post-treatment visit. The trial initially demonstrated sustained and statistically significant improvement in the primary endpoint, BCVA, at 13 months in the PBM treatment group when compared to the sham-treatment group (p = 0.02). Now, a sustained, mean increase in ETDRS letter score >5.0 letters from baseline is reported at both the 13- and 21-month timepoints in the PBM-treated subjects BCVA (p < 0.0001). The improvement from baseline in BCVA at 24 months in the PBM treatment group was significantly greater than in the sham group, 5.9 vs 1.0 letters (p = 0.0015). Approximately 58% of the PBM-treated eyes had >5 letter gain with a mean of 8.5 + 0.5 letter gain.
“Previously, the LIGHTSITE III trial results demonstrated sustained improvements of visual benefits with PBM treatments out to 13 months,” stated René Rückert, MD, MBA, Chief Medical Officer, LumiThera. “The trial results confirm the multi-center European LIGHTSITE II trial and extend the improvements to two years. We have been treating patients for about 4 years in Europe and Latin America in over 9,000 estimated patients. The sustained >5 letter improvement for 24 months was outstanding considering the earlier stage of AMD disease and the good BCVA at baseline in these patients.”
“The patients further underwent a detailed retinal morphology analysis using optical coherence tomography (OCT) during the course of the trial. Fewer eyes progressed to new geographic atrophy (GA), a later disease stage that is associated with permanent loss of retinal tissue. The 24-month OCT data indicated that 5 of 88 eyes (5.7%) in the PBM group had progressed to new GA, whereas 11 of 51 eyes (21.6%) in the sham arm developed new GA,” stated Glenn Jaffe, MD, Duke University, Duke Reading Center. “PBM treatment showed a statistically significant (p = 0.003) slowing of disease progression in patients with early to intermediate dry AMD.”
“These final results from the LIGHTSITE III trial are indeed very exciting and encouraging,” said Diana V. Do, MD and Quan Dong Nguyen, MD, MSc. Both are professors of ophthalmology and members of the Retina Division at the Byers Eye Institute at Stanford University, which is one of the clinical sites for the LIGHTSITE III trial. “PBM is a non-invasive therapy that can improve and sustain vision and slow the progression of disease. PBM is a significant advancement in saving sight for AMD patients. We are in urgent need of therapy for our patients with dry AMD, especially if the treatment is non-invasive such as the Valeda Light Delivery System.”
“Valeda’s multi-wavelength device is an unprecedented treatment option for dry AMD patients. PBM can offer a non-invasive treatment that can improve vision and potentially address the disease earlier, before we see permanent vision loss,” stated Clark Tedford, Ph.D., President and CEO. “Reductions in the number of eyes that progress to GA were seen at the 13-month and now further extended at the 24-month timepoints.”
The initial, first presentation worldwide of the top line data will be presented at the 2023 Sonoma Eye Meeting (March 17 to 19, San Diego, California) by one of the LIGHTSITE III trial investigators, Dr. Diana V. Do, Byers Eye Institute, Stanford University on Saturday, March 18, 2023.
About AMD
AMD is a leading cause of vision loss for people aged 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).
About LumiThera
LumiThera, Inc. is a medical device company focused on diagnosing, treating, and monitoring ocular disease and damage including dry age-related macular degeneration (AMD), a leading cause of blindness in adults over 65.
LumiThera’s flagship product, the Valeda® Light Delivery System, uses multiwavelength photobiomodulation to treat dry AMD patients. Valeda is CE Marked in the EU and is available in Europe and in countries in Latin America. Valeda is not yet approved by the Food & Drug Administration (FDA).
AdaptDx Pro® dark adaptation functional testing technology enables eye care professionals to detect and monitor AMD three years before clinical presentation. AdaptDx Pro is listed on the FDA’s Establishment Registration & Device Listing.
Diopsys ERG and VEP systems help eye care professionals analyze the entire pathway for visual and neuro-visual disorders. VEP is FDA-cleared. ERG and VEP are available in select countries outside of the USA.
LumiThera’s AMD Excellence Program® provides customer implementation, training, best practices, and ongoing support across all brands.
For more information on the Valeda® Light Delivery System please visit www.lumithera.com. The AdaptDx Pro and Diopsys ERG and VEP systems are available separately through LumiThera Diagnostics, Inc. and Diopsys, Inc.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230315005170/en/
Contact information
Allison Dabney
adabney@lumithera.com
Senior Director, Marketing
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
EVE Energy Showcases All-Scenario Energy Storage Solutions at The Smarter E Europe 20261.7.2026 04:45:00 EEST | Press release
EVE Energy unveiled its Mr. Big Family series, a 6.9+ MWh energy storage system, and all-scenario energy storage solutions at Intersolar Europe in Munich. Drawing on traceable large-cell technology, proven large-scale energy storage project delivery experience, and global delivery capabilities, the company is addressing Europe's diverse energy storage requirements across utility-scale, commercial & industrial (C&I ), and data center segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260630889717/en/ EVE Energy showcases its Mr. Giant 3.0 6.9+ MWh energy storage system at The Smarter E Europe 2026 in Munich, Germany Advancing Large-Cell Technology with Global Project Validation As one of the first companies to focus on large-capacity energy storage cells, EVE Energy has iteratively upgraded its cell platform from 560 Ah and 628 Ah to 702 Ah, adhering to a stacking process route throughout. At the exhibition, the Mr. Gia
Bending Spoons S.p.A. announces pricing of initial public offering1.7.2026 02:56:00 EEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the pricing of its initial public offering (“IPO”) at $29.00 per share. A total of 57,971,015 ordinary shares are being offered, of which 34,398,640 shares are being offered by Bending Spoons and 23,572,375 shares are being offered by certain selling shareholders (the “Selling Shareholders”). Bending Spoons will not receive any proceeds from any sale of shares by the Selling Shareholders. The shares are expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “BSP” on July 1, 2026. The offering is expected to close on July 2, 2026, subject to customary closing conditions. In addition, Bending Spoons and the Selling Shareholders granted the underwriters an option to purchase up to an additional 5,244,026 ordinary shares from Bending Spoons and up to an additional 3,451,626 ordinary shares from the Selling Shareholders at the initial public offering price, less underwriting
FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products30.6.2026 19:19:00 EEST | Press release
Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” “FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” saidStacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adultshave access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease and lung cancer,” she added. “More broadly, it reinforces the agency’s science-based approach to evaluating products across the co
Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution30.6.2026 18:00:00 EEST | Press release
Caidya today announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution. The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programs to scale, maintaining focus, speed, and accountability. The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies. With established operations across Europe, the Americas, APAC, and China, the combined organization provides meaningful expertise and execution capabilities in the regions that matter most. Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organizations strengthen their ability to support complex, cross-border
Archer® Proves Purpose-Built AI Beats General-Purpose LLMs on Regulatory Change Management: 95% Verified Accuracy, 80x Faster, 92% Lower Cost30.6.2026 17:13:00 EEST | Press release
For enterprises deploying AI in compliance, a wrong date is a missed deadline. The more dangerous failure is a wrong answer the model returns with high confidence, one that flows silently into a compliance calendar and is only discovered after the window has passed. Archer® today released results showing purpose-built AI beats a general-purpose large language model (LLM) on regulatory work, and it’s not close. This head-to-head test compared Archer’s purpose-built, vertical-specific AI and proprietary data sets against a leading general-purpose LLM, on a core compliance task: determining the publication, effective and comment-close dates of regulatory documents across six jurisdictions. General-purpose models are a genuine breakthrough, and this is no referendum on their quality. The question Archer set out to answer is narrower and more practical: what it takes to make a specific, high-stakes determination reliable, fast and affordable at scale. A vertical, domain-focused process, gro
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom