WA-LUMITHERA

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.

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