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

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 DIAMONDS^1-4 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.

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.

June 2025 PR0001

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