Iridex Announces Milestone Five-Year Study Confirms the Long-Term Effectiveness and Safety of MicroPulse Transscleral Cyclophotocoagulation for Glaucoma Management

Rhea-AI Summary

Iridex (IRIX) announced a landmark five-year peer-reviewed study published in Ophthalmology Therapy, demonstrating the long-term effectiveness of their MicroPulse Transscleral Laser Therapy (TLT) for glaucoma treatment. The study, conducted at University Eye Clinic Maastricht, evaluated 165 eyes with 112 completing the five-year follow-up.

Key findings showed significant results using the Cyclo G6® Laser and MicroPulse P3® Delivery Device: a 32.5% average reduction in intraocular pressure (IOP), decreased need for IOP-lowering medications, and only 38% of eyes requiring retreatment. The study confirms TLT as a viable alternative to invasive surgery, with sustained effectiveness and minimal complications across various glaucoma types.

Positive

• 32.5% average reduction in intraocular pressure achieved
• Low retreatment rate of only 38% over five years
• Significant reduction in IOP-lowering medication requirements
• Proven safety and effectiveness over long-term (5-year) period
• Demonstrated viability as alternative to invasive surgery

Negative

• None.

Insights

Medical Research Analyst

The five-year study on MicroPulse Transscleral Cyclophotocoagulation (TLT) represents a significant clinical validation for Iridex's technology. The data showing a 32.5% reduction in intraocular pressure with statistical significance (p<0.001) and decreased medication requirements (p<0.005) establishes strong clinical evidence for the treatment's efficacy. The 38% retreatment rate over five years is particularly noteworthy, as it demonstrates both durability and repeatability without increased complications.

The study's robust design with 165 initial eyes and 112 completing five-year follow-up provides reliable evidence for clinical adoption. For glaucoma management, having a non-incisional option that can be safely repeated represents a paradigm shift from traditional surgical approaches. This positions Iridex's technology as a potential first-line treatment option before more invasive surgeries, potentially expanding their addressable market significantly.

Financial Analyst

This clinical validation strengthens Iridex's market position in the $6 billion global glaucoma treatment market. The demonstrated long-term efficacy and safety profile could drive increased adoption of the Cyclo G6® Laser system and recurring revenue from MicroPulse P3® Delivery Devices. The ability to position this as a repeatable, non-invasive alternative to surgery presents significant revenue potential through both initial system sales and ongoing consumable usage.

For a small-cap company with a market cap of $27.45M, this peer-reviewed validation could catalyze institutional interest and support market penetration. The reduced need for glaucoma medications also presents a compelling economic argument to payers and providers, potentially accelerating reimbursement coverage and adoption rates. This study effectively de-risks the technology's long-term viability and could drive valuation multiple expansion.

MOUNTAIN VIEW, Calif., Dec. 18, 2024 (GLOBE NEWSWIRE) -- Iridex Corporation (Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems and delivery devices for the treatment of glaucoma and retinal diseases, today announced the publication of a landmark peer-reviewed study in Ophthalmology Therapy. This study highlights the sustained safety and efficacy of MicroPulse Transscleral Laser Therapy (TLT) (also referred to as Transscleral Cyclophotocoagulation) in managing both primary and secondary glaucoma over five years. Conducted by Dr. Ronald de Crom and colleagues at the University Eye Clinic Maastricht, Netherlands, this research is the first to evaluate outcomes of MicroPulse TLT over such an extended period.

The study assessed 165 pre- and post-cataract eyes treated between 2016 and 2019, with 112 eyes completing the five-year follow-up. Treatment was delivered using the Iridex Cyclo G6® Laser in its MicroPulse® Mode and the original MicroPulse P3® Delivery Device. Results demonstrated that MicroPulse TLT achieved significant (p<0.001) reductions in intraocular pressure (IOP)—32.5% on average—while also enabling a significant reduction (p<0.005) in IOP-lowering medications with a low rate of complications across a broad range of glaucoma types and severities.

"These findings suggest MicroPulse TLT can be a viable alternative to invasive incisional glaucoma surgery, particularly in patients with secondary glaucoma and those for whom incisional surgery may be challenging,” said Dr. de Crom. "Its ability to achieve sustained IOP reduction with minimal complications makes it a cornerstone treatment option."

Additionally, over the five-year follow-up period, only 38% of eyes required retreatment. “Patients who underwent retreatments achieved similar levels of success as those treated initially with no significant increase in complication risk.” Dr. de Crom continued, "The ability to safely repeat MicroPulse treatments while continuing long-term glaucoma care management without having to progress to more invasive glaucoma surgeries, is a huge advantage to clinicians and patients alike!"

Patrick Mercer, CEO of Iridex, commented, "This is the first long-term, peer-reviewed study that demonstrates the safety, effectiveness, and repeatability of MicroPulse TLT. This milestone study supports our commitment to delivering innovative, non-incisional solutions that improve patient outcomes while creating value for our investors and customers.”

About Iridex Corporation

Iridex Corporation is a worldwide leader in developing, manufacturing, and marketing innovative and versatile laser-based medical systems, delivery devices and consumable instrumentation for the ophthalmology market. The Company’s proprietary MicroPulse® technology delivers a differentiated treatment that provides 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.

MicroPulse® is a registered trademark of Iridex Corporation, Inc. in the United States, Europe and other jurisdictions. © 2024 Iridex Corporation. All rights reserved.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Act of 1934, as amended, including those statements concerning clinical expectations and commercial trends, market adoption and expansion, value-maximizing transactions, demand for and utilization of the Company's products and results and expected sales volumes. The Company can provide no assurance that it will complete any value-maximizing transactions on behalf of its stockholders. These statements are not guarantees of future performance and actual results may differ materially from those described in these forward-looking statements as a result of a number of factors. Please see a detailed description of these and other risks contained in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2024. Forward-looking statements contained in this announcement are made as of this date and will not be updated.

Media Contact
Joan Staufer
jstauffer@iridex.com

Investor Relations Contact
Philip Taylor
Gilmartin Group
investors@iridex.com

FAQ

What were the key results of IRIX's 5-year MicroPulse TLT study?

The study showed a 32.5% average reduction in intraocular pressure, decreased need for medications, and only 38% retreatment rate over five years, with minimal complications.

How many patients completed IRIX's 5-year glaucoma treatment study?

Out of 165 initial eyes treated between 2016 and 2019, 112 eyes completed the full five-year follow-up period.

What is the retreatment rate for IRIX's MicroPulse TLT therapy?

The study showed that only 38% of eyes required retreatment over the five-year follow-up period.

Can IRIX's MicroPulse TLT treatment be safely repeated?

Yes, the study demonstrated that retreatments achieved similar success levels as initial treatments with no significant increase in complication risk.

What equipment does IRIX use for MicroPulse Transscleral Laser Therapy?

IRIX uses the Cyclo G6® Laser in MicroPulse® Mode and the MicroPulse P3® Delivery Device for the treatment.