LumiThera Launches Global PBM Trial for Dry AMD

LumiThera has announced a pioneering initiative - the initiation of the largest Photobiomodulation (PBM) trial ever conducted in patients with dry Age-Related Macular Degeneration (AMD).

Partnering with UK-based Dendrite Clinical Systems LTD, a leader in registry studies, LumiThera aims to collect valuable real-world data on the efficacy and safety of its Valeda Light Delivery System through a global registry named EUROLIGHT (European Union Registry Study).

Unprecedented Scale and Collaborative Endeavor

The EUROLIGHT Registry Study is designed to enroll an extensive cohort of 500 to 1,000 patients who have undergone PBM treatment for dry AMD over the past three years. Initially involving up to 20 European centers, the study holds the potential for expansion into countries outside the European Union (EU) where Valeda has received approval. This initiative represents an unprecedented collaboration between LumiThera and Dendrite Clinical Systems LTD, leveraging the latter's expertise in structured data registry studies.

Objectives and Focus of EUROLIGHT

EUROLIGHT aims to collect safety and clinical efficacy outcomes, including critical parameters like best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) imaging data. The study will tap into multiple centers actively treating dry AMD subjects, providing a real-world perspective on the use of PBM through the Valeda Light Delivery System.

The study employs a dual approach to data collection - retrospectively gathering existing data from subjects treated with PBM every 4-6 months for up to three years and prospectively following patients to provide real-time insights into outcomes.

Global Impact and Real-World Data

The ongoing registry collection will include patients across various stages of AMD, providing evidence of safety, clinical efficacy, and biomarkers from imaging data. With an estimated 16,000 patients treated in Europe and Latin America to date, this dataset is poised to offer substantial insights into PBM treatment and AMD disease progression on a global scale.

The Role of Duke Reading Center

Duke Reading Center, renowned for its independent image reading expertise, has been selected to review data from the real-world use of Valeda. Dr. Glenn Jaffe, Robert Machemer Professor of Ophthalmology at Duke University and Director of Duke Reading Center, expressed excitement about the unique dataset that the global registry study will provide. The study is expected to offer insights into disease biomarkers, progression, and factors such as drusen deposition and new geographic atrophy (GA) formation and lesion growth rates.