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
DAME Trial Enrollment: Iridex Corporation announced the successful enrollment of the first patient in the DAME Trial, which aims to evaluate the efficacy and safety of adding subthreshold MicroPulse treatments to anti-VEGF therapy for patients with severe diabetic macular edema (DME) across 20 clinical sites in the UK.
Potential Impact on Treatment: The trial, led by Professor Noemi Lois, seeks to determine if the new treatment pathway could reduce the need for frequent anti-VEGF injections, potentially lowering costs and risks associated with current DME treatments while improving patient outcomes.
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- Significant Revenue Growth: IRIDEX reported total revenue of $14.7 million for Q4 2025, reflecting a 16% year-over-year increase, indicating sustained growth in core product lines, particularly in glaucoma and retina segments, which suggests strong market demand.
- Cost Control Initiatives: The company plans to achieve quarterly savings of $165,000 starting Q1 2026 by relocating certain administrative functions out of California, and expects to reduce annual fixed costs by approximately $600,000 through a planned headquarters relocation, further enhancing profitability.
- Strong Product Sales: In Q4, the glaucoma business sold 15,900 probes and 44 G6 systems, with total probe sales reaching 57,800 and system sales at 133 for the year, demonstrating the market acceptance and growth potential of the Cyclo G6 platform.
- Optimistic Future Outlook: IRIDEX expects 2026 revenue to range from $51 million to $53 million, excluding contributions from the Middle East, indicating a growth potential of 1% to 5%, with management expressing confidence in future cash flows and margin improvements.
- Earnings Performance: IRIDEX reported a Q4 GAAP EPS of -$0.01, beating expectations by $0.01, indicating a slight improvement in profitability despite missing revenue targets.
- Revenue Growth: Total revenue for 2025 reached $52.7 million, an 8% increase from $48.7 million in 2024, reflecting a stable growth trend in the market, particularly driven by the glaucoma product line.
- Product Sales: Revenue from the Cyclo G6® glaucoma product family was $13.8 million, up from $12.7 million in 2024, with sales of Cyclo G6® probes increasing from 55,400 to 57,800, demonstrating sustained demand for the products.
- Cost Control: The company reduced operating expenses by 22% compared to the previous year, which not only enhances overall profitability but also provides greater financial flexibility for future investments and expansions.

Market Disruptions: IrideX Corp. is assessing the impact of market disruptions caused by ongoing conflicts in the Middle East.
Product Delivery Challenges: The conflicts are affecting product delivery timelines, leading to potential delays and complications in supply chains.
- Financial Performance: IrideX reported a gross profit of $5.5 million for the fourth quarter.
- Market Impact: The financial results indicate a positive trend in the company's performance, potentially influencing investor confidence.

- Clinical Study Results: An independent study at the University Eye Clinic Maastricht shows that retreatment with MicroPulse laser treatment (MicroPulse TLT) reduces intraocular pressure (IOP) by 25% to 35% in glaucoma patients, demonstrating the technology's effectiveness and safety in glaucoma management.
- Treatment Flexibility: The study involved 76 eyes, with retreatment timing varying from approximately 4 months to over 28 months, showcasing the individualized management capabilities of the technology, allowing for flexible treatment adjustments based on patient responses.
- Success Rate of Repeat Treatments: Results indicate that patients who initially benefited from treatment have higher long-term success rates upon retreatment, aiding clinicians in better identifying candidates for retreatment and optimizing glaucoma management strategies.
- Company Strategic Commitment: Iridex CEO Patrick Mercer stated that the findings further validate MicroPulse TLT as a valuable non-incisional option, reflecting the company's strong commitment to advancing clinical evidence and supporting ophthalmologists in delivering durable outcomes for their patients.






