WA-LUMITHERA
16.1.2024 13:08:34 CET | Business Wire | Press release
LumiThera Inc., a medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, today announced the initiation of the largest PBM trial ever conducted in patients with dry age-related macular degeneration (AMD). A global registry data collection from patients treated with PBM using the Valeda® Light Delivery System (Valeda) has been established with Dendrite Clinical Systems LTD, a UK-based company specializing in registry studies. The multi-center clinical registry study will enroll 500-1,000 patients treated with PBM over the past three years. The study will initially include up to 20 European centers and could be expanded in other countries outside the Europe Union (EU) where Valeda is approved.
EUROLIGHT (European Union Registry Study) will collect safety and clinical efficacy outcomes such as best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) imaging data from multiple centers that have been treating dry AMD subjects in their practice. The large registry will collect data retrospectively with centers providing existing data from subjects who underwent PBM treatment every 4-6 months for up to three years. Patients will continue to be followed prospectively. The data will be used to support reimbursement in multiple countries and provide important clinical information on real-world use of Valeda. The study has targeted select European centers with extensive expertise in the use of Valeda.
“The LIGHTSITE series of trials demonstrated improvements of visual benefits with PBM treatments in a prospective randomized clinical trial (RCT) design,” stated René Rückert, MD, MBA, Chief Medical Officer, LumiThera. “The RCT results demonstrated clinical benefits in early to intermediate patients out to two years with anatomical evidence of slowing of AMD disease progression.”
The current registry collection will examine patients from early through late stage AMD disease and provide evidence of safety, clinical efficacy and biomarkers from imaging data. An estimated 16,000 patients in Europe and Latin America have been treated to date and represents a valuable dataset to garner further information about PBM treatment and AMD disease progression.
“We are very excited that the Duke Reading Center has been chosen as the independent image reading center to review data from real-world use of Valeda,” stated Glenn Jaffe, MD, Robert Machemer Professor of Ophthalmology, Duke University and Director of Duke Reading Center. “PBM treatment showed a statistically significant slowing of disease progression in patients with early to intermediate dry AMD for up to two years in the LIGHTSITE III study. The global registry study will provide us with a unique dataset to evaluate disease biomarkers and disease progression, including drusen deposition and new geographic atrophy (GA) formation and lesion growth rates.”
“We are thrilled to be part of the EUROLIGHT study,” said Oygunn Uthiem, MD, PhD, Norwegian Dry Eye Clinic/Øyehelseklinikken, Department of Medical Biochemistry/Department of Ophthalmology, Oslo University Hospital. “We have treated over 350 patients in the last four years and have seen the real-world benefits of Valeda treatments in our patients. We have started to upload data into the registry database and have obtained over 70 informed consents from patients that want to be part of the study. Our patients have strictly followed the clinical trial protocols and been tested every 4-6 months, some for up to four years.”
“We have seen recent publications from the real-world setting that mirror our RCT trial results and we have several years of experience with Valeda treatments in the EU and LATAM,” stated Clark Tedford, Ph.D., President and CEO, LumiThera. “The ability to collect additional safety and efficacy data from our global experiences will help us continue to study the safety and effectiveness of PBM in early to late-stage disease treatment of dry AMD and its effect on the progression of disease and growth of GA lesion rates with detailed anatomical OCT analysis in several subsets of patients.”
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, read or do close-up work like cooking or fixing things around the house. The overall prevalence of AMD is estimated to increase seven-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 Dendrite
Dendrite Clinical Systems is a UK-headquartered international company with over a 25-year track record as a specialist provider of secure clinical registries, analysis software and consultancy services for the international healthcare sector, specifically for clinical research, multi-centre real-world studies, observational registries, international, national and hospital clinical databases.
Dendrite has been recognised as a leading provider of clinical registries across various specialties with a unique track record of implementing over 200 major clinical registry systems globally including systems for major research projects for medical device companies, CROs and pharmaceutical companies.
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/20240116921449/en/
About Business Wire
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
Brenus Pharma Presented New Preclinical and Early Clinical Data in Colorectal Cancer During AACR Immuno-Oncology Conference 202619.2.2026 08:50:00 CET | Press release
Brenus Pharma, a clinical-stage biotechnology company pioneering in vivo “off-the-shelf” immunotherapies, announced the selection of an abstract for a poster presentation at the American Association for Cancer Research Immuno-Oncology (AACRIO) annual conference (February 18-21, 2026), in Los Angeles. The poster showcases new preclinical data and early clinical insights from the company's lead candidate, STC-1010, supporting it as a promising therapeutic option for MSS, immune-cold colorectal cancer (CRC)—a major unmet clinical need. In a syngeneic CT26 model, murine STC-1010 significantly inhibits tumor growth and extends survival by 40%. New mechanistic datas reveal expansion of CD4⁺ and CD8⁺ T cells in draining lymph nodes alongside a significant humoral response compared to control, demonstrating coordinated cellular and humoral immune activation in vivo. Other findings show that dendritic cells efficiently capture STC-1010, leading to their activation as demonstrated by transcripto
ENHERTU® Type II Variation Application Validated in the EU as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer19.2.2026 08:30:00 CET | Press release
Based on DESTINY-Breast05 phase 3 trial results, which showed ENHERTU reduced the risk of invasive disease recurrence or death by 53% compared to T-DM1 If approved, Daiichi Sankyo and AstraZeneca’s ENHERTU has the potential to become a new standard of care in this early breast cancer setting The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU® (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment. ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The validation confirms the completion of the application and commences the scientific review process by the EMA’s Committ
NHOA Energy Advances Delivery of the 51 MWh Broni Battery for Neoen in Italy19.2.2026 08:00:00 CET | Press release
The project confirms NHOA Energy’s long-term commitment to the Italian market NHOA Energy, global provider of utility-scale energy storage systems, is advancing the construction of the Broni Battery, a 10 MW/51 MWh project located in Broni (Pavia), Italy, executed for Neoen, one of the world’s leading independent producers of renewable energy. Civil works at the site are currently underway and advancing on schedule, with commissioning activities planned to start in late spring 2026. Once operational, the Broni Battery will provide essential flexibility services to the Italian electricity system, supporting grid stability and reliability as renewable energy penetration continues to increase. The project represents Neoen’s first battery storage asset in Italy and marks a strategic step in the company’s expansion, as it continues to grow its battery storage portfolio in key markets worldwide to support power system flexibility. The Broni Battery further strengthens NHOA Energy’s long-term
Compass Pathways Announces Pricing of $150 Million Public Offering19.2.2026 02:18:00 CET | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the pricing of its public offering of 17,500,000 American Depositary Shares (“ADSs”) at a public offering price of $8.00 per ADS, each representing one ordinary share, and in lieu of ADSs, to certain institutional investors, pre-funded warrants to purchase up to 1,250,000 ADSs at a public offering price of $7.9999 per pre-funded warrant. In addition, Compass Pathways has granted the underwriters a 30-day option to purchase up to an additional 2,812,500 ADSs at the public offering price, less the underwriting discounts and commissions. All of the securities are to be sold by Compass Pathways. The offering is expected to close on or about February 20, 2026, subject to the satisfaction of customary closing conditions. The gross proceeds to Compass Pathways from the offering, before deducting underwriting discounts and commissions and other est
Andersen Consulting udvider sine kompetencer inden for ledelsesrekruttering med Lansdowne Executive Search18.2.2026 17:08:00 CET | Pressemeddelelse
Andersen Consulting styrker sin humancapital-praksis gennem en samarbejdsaftale med Lansdowne Executive Search, der er en Dublin-baseret virksomhed med speciale i lederrekruttering, midlertidige ledelser og bestyrelsesudnævnelser. Lansdowne Executive Search er en irisk-ejet virksomhed, der blev grundlagt i 2015, og som tilbyder C-level-ledelsesekruttering, deltidsledere og bestyrelsesplaceringer. Som en partnerdrevet boutique-virksomhed er Lansdowne kendt for, at seniorledelsen er tæt involveret i alle kundeprojekter. Virksomheden hjælper kunder med at navigere i komplekse ledelsesovergange og vækststrategier på tværs af en bred vifte af sektorer, herunder finans, byggeindustrien, nonprofit, landbrug, videregående uddannelse, den offentlige sektor samt teknologi, medier og telekommunikation. "God ledelse er afhænger af situationen, og det kræver forståelse af langt mere end blot et CV," sagde Tom Keane, der er partner hos Lansdowne Executive Search. "Samarbejdet med Andersen Consulting
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