Clinical Evidence & Regulatory Status

Healthcare Professional Information
Clinical Evidence & Regulatory Status
Valeda® Light Delivery System by LumiThera, Inc. – Evidence-based photobiomodulation for dry age-related macular degeneration
View Evidence
Regulatory Information
Regulatory Status
CE Marking
Valeda® holds CE marking for the UK and European Union, meeting applicable medical device regulations for commercialisation and clinical use.
U.S. FDA Authorisation
The device has received U.S. Food and Drug Administration authorisation for the treatment of dry AMD with the specific indication to improve vision.
Regional Variations
Clinicians should be aware that indications, labelling, and approved uses may vary by jurisdiction. Always consult local regulatory documentation and manufacturer materials relevant to your practice location.
Important: Regulatory status, approved indications, and device labelling differ between regions. Healthcare professionals must refer to the specific regulatory approvals and instructions for use applicable in their jurisdiction before prescribing or administering treatment.
Clinical Programme Overview
Valeda® photobiomodulation therapy has been evaluated through a comprehensive clinical development programme spanning multiple investigational studies in patients with dry age-related macular degeneration.
The clinical evidence base includes the LIGHTSITE studies and subsequent follow-on and extension programmes designed to assess both safety and efficacy outcomes in real-world clinical populations.
These studies have examined treatment effects across various measures of visual function and retinal health, with standardised protocols for light delivery, patient selection criteria, and outcome assessment methodologies.
The clinical programme continues to evolve, with ongoing data collection and analysis contributing to the understanding of photobiomodulation in retinal disease management.
Study Components
Multi-centre controlled trials
Long-term extension studies
Real-world evidence collection
Safety monitoring programmes
What the Evidence Shows
Clinical studies of Valeda® have investigated multiple parameters relevant to visual function and retinal health in patients with dry AMD. The following outcomes have been assessed across the clinical programme:
Visual Function Measures
Clinical studies have reported improvements in visual function measures such as best-corrected visual acuity and contrast sensitivity in patients with dry age-related macular degeneration receiving photobiomodulation therapy.
Retinal Structure Assessment
Studies have evaluated changes in retinal structure using advanced imaging modalities, including optical coherence tomography and fundus photography, to document anatomical changes over the treatment period.
Functional Outcomes
Functional measures of retinal health have been assessed through various testing methodologies, providing objective data on photoreceptor function and retinal physiology following treatment.
Clinical interpretation: Individual patient responses may vary. These findings represent aggregate data from clinical trial populations and should be interpreted within the context of each patient's clinical presentation, comorbidities, and disease stage. Treatment outcomes are not guaranteed for all patients.
Safety Profile
Adverse Event Reporting
Clinical trial data to date have reported no treatment-related adverse events attributable to the Valeda® photobiomodulation protocol when administered according to manufacturer guidelines and within approved parameters.
As with any bright light exposure, patients may experience brief after-images or temporary photostress immediately following treatment sessions. These effects are generally transient and resolve spontaneously within a short period.
Comprehensive pre-treatment assessment, patient selection, informed consent, and appropriate clinical monitoring remain essential components of safe treatment delivery.
01
Patient Assessment
Thorough evaluation of suitability, contraindications, and concurrent ocular conditions
02
Informed Consent
Discussion of treatment rationale, expected outcomes, potential effects, and alternatives
03
Treatment Delivery
Administration according to validated protocols with appropriate safety monitoring
04
Clinical Follow-Up
Scheduled reassessment to monitor response, document outcomes, and identify any concerns
Evidence Links & Resources
Healthcare professionals seeking detailed clinical information may access the following resources. Zollara Vision Services can assist with obtaining specific publications or technical documentation.
Manufacturer Clinical Summaries
Technical and clinical documentation provided by LumiThera, Inc., including instructions for use, clinical trial summaries, and device specifications.
[Link to be provided]
Peer-Reviewed Publications
Published research articles in ophthalmology and optometry journals presenting trial results, methodology, and outcomes from the Valeda® clinical programme.
[Link to be provided]
Global Valeda Publications
Comprehensive repository of international clinical data, conference presentations, and ongoing research related to photobiomodulation in retinal disease.
[Link to be provided]
Clinical Responsibility Statement
This page provides informational content for qualified healthcare professionals and does not replace independent clinical judgement or professional assessment of individual patient circumstances.
Patient selection, informed consent procedures, diagnostic imaging, treatment protocols, and ongoing clinical follow-up remain the sole responsibility of the treating eye care professional. Each clinician must evaluate the appropriateness of any intervention based on their professional training, clinical experience, and the specific presentation of each patient.
Zollara Vision Services, a division of Zollara Ltd, provides equipment and support services to optometry practices but does not diagnose patients, prescribe treatment, provide clinical advice, or bill patients directly for clinical services.
Information for Healthcare Professionals OnlyNot for Patient Distribution

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