Iridex Announces First Patient Enrolled in an Independent Landmark Investigator-Led UK Study Evaluating MicroPulse® Technology as an Adjunct to anti-VEGF Therapy for Diabetic Macular Edema
Iridex Corporation (NASDAQ: IRIX) announced the enrollment of the first patient in the independent DAME Trial, evaluating the combination of MicroPulse technology with anti-VEGF therapy for severe diabetic macular edema (DME). The UK-based study, led by Professor Noemi Lois at Queen's University Belfast, aims to enroll 264 participants across 20 clinical sites.
The trial will assess the clinical efficacy, safety, cost-effectiveness, and patient acceptability of adding subthreshold MicroPulse treatments to anti-VEGF therapy. The study focuses on patients with severe DME, defined by central retinal subfield thickness ≥400 μm. The research is funded by the National Institute for Health Research (NIHR) and utilizes Iridex's IQ 577® laser system with MicroPulse® treatment mode and TxCell® Scanning Delivery Device.
Iridex Corporation (NASDAQ: IRIX) ha annunciato l'arruolamento del primo paziente nello studio indipendente DAME, che valuta la combinazione della tecnologia MicroPulse con la terapia anti-VEGF per l'edema maculare diabetico (DME) grave. Lo studio, basato nel Regno Unito e guidato dalla Professoressa Noemi Lois presso la Queen's University di Belfast, prevede l'arruolamento di 264 partecipanti in 20 centri clinici.
La sperimentazione valuterà l'efficacia clinica, la sicurezza, la convenienza economica e l'accettabilità da parte dei pazienti dell'aggiunta di trattamenti MicroPulse a soglia submassimale alla terapia anti-VEGF. Lo studio si concentra su pazienti con DME grave, definito da uno spessore del sottocampo retinico centrale ≥400 μm. La ricerca è finanziata dal National Institute for Health Research (NIHR) e utilizza il sistema laser IQ 577® di Iridex con modalità di trattamento MicroPulse® e dispositivo di erogazione TxCell® Scanning Delivery Device.
Iridex Corporation (NASDAQ: IRIX) anunció la inscripción del primer paciente en el ensayo independiente DAME, que evalúa la combinación de la tecnología MicroPulse con la terapia anti-VEGF para el edema macular diabético (DME) severo. El estudio, basado en el Reino Unido y dirigido por la profesora Noemi Lois en la Queen's University de Belfast, tiene como objetivo inscribir a 264 participantes en 20 centros clínicos.
El ensayo evaluará la eficacia clínica, seguridad, rentabilidad y aceptabilidad para el paciente de añadir tratamientos MicroPulse subumbral a la terapia anti-VEGF. El estudio se centra en pacientes con DME severo, definido por un grosor del subcampo retiniano central ≥400 μm. La investigación está financiada por el National Institute for Health Research (NIHR) y utiliza el sistema láser IQ 577® de Iridex con modo de tratamiento MicroPulse® y dispositivo de entrega TxCell® Scanning Delivery Device.
Iridex Corporation (NASDAQ: IRIX)가 독립적인 DAME 임상시험에 첫 환자를 등록했다고 발표했습니다. 이 시험은 중증 당뇨성 황반부종(DME)에 대해 MicroPulse 기술과 항-VEGF 치료의 병용 효과를 평가합니다. 영국에 기반을 둔 이 연구는 벨파스트 퀸스 대학교의 노에미 로이스 교수님이 주도하며, 20개 임상 기관에서 264명의 참가자를 모집하는 것을 목표로 합니다.
이 임상시험은 항-VEGF 치료에 서브스레숄드 MicroPulse 치료를 추가했을 때의 임상적 효능, 안전성, 비용 효율성 및 환자 수용성을 평가합니다. 연구 대상은 중심 망막 하위 영역 두께가 400μm 이상인 중증 DME 환자입니다. 본 연구는 National Institute for Health Research (NIHR)의 지원을 받으며, Iridex의 IQ 577® 레이저 시스템과 MicroPulse® 치료 모드, TxCell® 스캐닝 전달 장치를 사용합니다.
Iridex Corporation (NASDAQ : IRIX) a annoncé l'inscription du premier patient dans l'essai indépendant DAME, qui évalue la combinaison de la technologie MicroPulse avec la thérapie anti-VEGF pour l'œdème maculaire diabétique (DME) sévère. Cette étude basée au Royaume-Uni, dirigée par la professeure Noemi Lois à la Queen's University de Belfast, vise à recruter 264 participants répartis sur 20 sites cliniques.
L'essai évaluera l'efficacité clinique, la sécurité, la rentabilité et l'acceptabilité par les patients de l'ajout de traitements MicroPulse sous-seuil à la thérapie anti-VEGF. L'étude cible les patients atteints de DME sévère, défini par une épaisseur du sous-champ rétinien central ≥400 μm. La recherche est financée par le National Institute for Health Research (NIHR) et utilise le système laser IQ 577® d'Iridex avec le mode de traitement MicroPulse® et le dispositif d'administration TxCell® Scanning Delivery Device.
Iridex Corporation (NASDAQ: IRIX) gab die Einschreibung des ersten Patienten in die unabhängige DAME-Studie bekannt, die die Kombination der MicroPulse-Technologie mit der anti-VEGF-Therapie bei schwerem diabetischem Makulaödem (DME) untersucht. Die in Großbritannien ansässige Studie unter der Leitung von Professor Noemi Lois an der Queen's University Belfast plant die Einschreibung von 264 Teilnehmern an 20 klinischen Standorten.
Die Studie wird die klinische Wirksamkeit, Sicherheit, Kosteneffizienz und Akzeptanz bei Patienten bewerten, wenn subthreshold MicroPulse-Behandlungen zur anti-VEGF-Therapie hinzugefügt werden. Der Fokus liegt auf Patienten mit schwerem DME, definiert durch eine zentrale Netzhautfelddicke von ≥400 μm. Die Forschung wird vom National Institute for Health Research (NIHR) finanziert und verwendet das IQ 577® Lasersystem von Iridex mit MicroPulse®-Behandlungsmodus und TxCell® Scanning Delivery Device.
- Potential to reduce frequency of anti-VEGF injections, lowering treatment costs and patient burden
- Large-scale trial with 264 participants across 20 UK clinical sites adds credibility
- Trial funded by National Institute for Health Research (NIHR), reducing company costs
- Exclusive use of Iridex technology in the trial enhances company visibility and potential market adoption
- Results of the trial are uncertain and could impact adoption of the technology
- Long-term timeline for trial completion and potential implementation
- Success depends on proving equivalence to current standard anti-VEGF therapy
Insights
First patient enrolled in UK DAME trial could validate Iridex's MicroPulse technology as a cost-effective DME treatment alongside anti-VEGF therapy.
Iridex (IRIX) has reached a significant milestone with the first patient enrollment in the independent DAME Trial, which will evaluate the company's MicroPulse® technology as a complementary treatment to anti-VEGF therapy for diabetic macular edema (DME). This investigator-led study spans 20 clinical sites and aims to enroll 264 participants across the UK.
The trial has substantial strategic importance as it addresses a critical healthcare challenge. Current DME treatment protocols rely heavily on frequent anti-VEGF injections, which are both costly and burdensome for patients and healthcare systems. The DAME trial specifically examines whether adding subthreshold MicroPulse laser treatments once the central retinal subfield thickness drops below 400μm following anti-VEGF therapy can maintain visual outcomes while reducing injection frequency.
What makes this development particularly noteworthy is the potential market impact. If successful, the trial could establish a new treatment paradigm that reduces healthcare costs and patient burden while maintaining efficacy. The study's design as a blueprint for clinical implementation suggests a clear path to market adoption if outcomes are positive.
Importantly, the trial is being conducted by respected researchers led by Professor Noemi Lois at Queen's University Belfast and is funded by the UK's National Institute for Health Research, lending significant credibility. Iridex's IQ 577® laser with MicroPulse® treatment mode and TxCell® Scanning Delivery Device has been selected as the exclusive technology platform for this landmark study, highlighting its unique capabilities in delivering subthreshold treatments that activate natural healing without visible tissue damage.
MOUNTAIN VIEW, Calif., June 24, 2025 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems, delivery devices, and accessories for the treatment of glaucoma and retinal diseases, announced today that the first patient has been successfully enrolled in the independent, investigator-led DAME Trial to evaluate the clinical efficacy, safety, cost-effectiveness, and patient acceptability of adding subthreshold MicroPulse treatments to anti-vascular endothelial growth factor (anti-VEGF) therapy in patients presenting with severe diabetic macular edema (DME).
Led by Principal Investigator Professor Noemi Lois at Queen’s University Belfast, the study is designed to include at least 20 clinical sites and enroll 264 participants across the United Kingdom with severe DME, defined as having central retinal subfield thickness (CRT) or ≥400 μm once CRT goes below 400μm. The trial is intended to develop a blueprint for the implementation of the new treatment pathway (i.e., adding subthreshold MicroPulse laser only when the CRT is <400μm following anti-VEGFs) into clinical practice, if this is shown to be beneficial to people with DME.
“Current treatment for DME relies heavily on frequent anti-VEGF injections, which are not only expensive and burdensome to patients and healthcare systems but can also lead to patient anxiety along with having potential sight-threatening complications,” said Professor Lois. “DAME may transform the care of people living with diabetes and DME if the trial shows that continuing with subthreshold MicroPulse laser, once the DME has improved following anti-VEGFs, is equivalent in terms of visual outcomes to ongoing anti-VEGF therapy. This strategy may reduce the number of anti-VEGF injections required and, subsequently, risks, inconvenience, and costs to people and health care services. We are excited to have enrolled the first participant in the trial and we are indebted to the National Institute for Health Research (NIHR) in the UK for having funded this trial. We are also very grateful to Iridex and their UK distributor partner, Carleton Optical Equipment Ltd, for supplying the laser systems for this trial.”
The Iridex IQ 577® laser in its MicroPulse® treatment mode, paired with the TxCell® Scanning Delivery Device, allows clinicians to deliver controlled, subthreshold treatment that activates the retina’s natural healing response without causing visible tissue damage.
“We are honored that our IQ 577 laser, MicroPulse, and TxCell technologies are trusted as the exclusive platform for the DAME trial. Our technology enables consistent, safe and effective treatments for DME patients and we are excited to see its additional use investigated in this large-scale trial led by these respected clinicians,” said Patrick Mercer, Iridex President & CEO. “We congratulate Professor Lois and her team for this exciting milestone and commend their efforts to advance diabetic eye care to improve patients’ lives.”
About DAME
The DAME trial “Treatment of severe Diabetic macular oedema with Anti-vascular endothelial growth factor (anti-VEGF) monotherapy versus treatment with Anti-VEGF followed by subthreshold Micropulse lasEr” is an independent, investigator-led, pragmatic randomized equivalence trial funded by the Health Technology Assessment of the National Institute for Health Research (HTA-NIHR) in the UK. It is powered to demonstrate equivalence in best-corrected visual acuity outcomes between treatment arms over a 24-month period. Secondary outcomes include quality of life, cost-effectiveness, treatment burden, and patient-reported experience. The trial includes an implementation work package to develop a strategy to implement trial results into clinical practice.
The DAME Trial builds on the success of the DIAMONDS1-4 study, another independent, investigator-led, multi-center UK trial that demonstrated the safety and effectiveness of subthreshold MicroPulse® laser using the Iridex IQ 577® and TxCell® Scanning Delivery Device in patients presenting with DME of less than 400 μm in CRT.
Noemi Lois has no conflicts of interest to declare.
About Iridex Corporation
Iridex Corporation is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, which include capital equipment and consumable probes for the ophthalmology market. The Company’s proprietary MicroPulse® technology delivers the therapeutic benefits of laser treatment while minimizing tissue damage, offering a safe, effective, and proven treatment for targeted sight-threatening eye conditions. Iridex’s current product line is used for the treatment of glaucoma and diabetic macular edema (DME) and other retinal diseases. Iridex products are sold in the United States through a direct sales force and internationally primarily through a network of independent distributors into more than 100 countries. For further information, visit the Iridex website at www.iridex.com.
Media Contact
Joan Stauffer
jstauffer@iridex.com
Investor Relations Contact
Philip Taylor
Gilmartin Group
investors@iridex.com
For more information about Iridex technologies, visit www.iridex.com.
MicroPulse®, IQ 577® and TxCell® are registered trademarks of Iridex. ©2025 Iridex Corporation. All rights reserved.
References
1. Mistry H, Maredza M, Campbell C, Lois N, Diamonds study group. Subthreshold micropulse laser versus standard laser for the treatment of central-involving diabetic macular oedema with central retinal thickness of <400µ: A cost-effectiveness analysis from the DIAMONDS trial. BMJ Open. 2023;13(10):e067684.
2. Lois N, Gardner E, Waugh N, Azuara-Blanco A, Mistry H, McAuley D, Acharya N, Aslam TM, Bailey C, Chong V, Downey L, Eleftheriadis H, Fatum S, George S, Ghanchi F, Groppe M, Hamilton R, Menon G, Saad A, Sivaprasad S, Shiew M, Steel DH, Talks JS, Adams C, Campbell C, Mills M, Clarke M, Group DS. Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): Study protocol for a randomised controlled trial. Trials. 2019;20(1):122.
3. Lois N, Campbell C, Waugh N, Azuara-Blanco A, Maredza M, Mistry H, McAuley D, Acharya N, Aslam TM, Bailey C, Chong V, Downey L, Eleftheriadis H, Fatum S, George S, Ghanchi F, Groppe M, Hamilton R, Menon F, Saad A, Sivaprasad S, Shiew M, DH S, Talks JS, Doherty P, McDowell C, Clarke M. Standard threshold laser versus subthreshold micropulse laser for adults with diabetic macular oedema: The DIAMONDS non-inferiority rct. Health Technol Assess. 2022;26(50):1-86.
4. Lois N, Campbell C, Waugh N, Azuara-Blanco A, Maredza M, Mistry H, McAuley D, Acharya N, Aslam TM, Bailey C, Chong V, Downey L, Eleftheriadis H, Fatum S, George S, Ghanchi F, Groppe M, Hamilton R, Menon G, Saad A, Sivaprasad S, Shiew M, Steel DH, Talks JS, Doherty P, McDowell C, Clarke M, Diamonds study group. Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): A randomized double-masked non-inferiority clinical trial. Ophthalmology. 2022.
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FAQ
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