Iridex Comments on Changing Glaucoma Reimbursement Landscape

IRIX 11.19.2024

Full Press ReleaseSEC FilingsOur IRIX Tweets

About Gravity Analytica

Recent News

  • 01.14.2025 - Iridex Announces Preliminary Operational and Financial Results for Fourth Quarter and Full Year 2024
  • 01.13.2025 - Patrick Mercer
  • 12.18.2024 - Iridex Announces Milestone Five-Year Study Confirms the Long-Term Effectiveness and Safety of MicroPulse Transscleral Cyclophotocoagulation for Glaucoma Management

Recent Filings

  • 01.14.2025 - EX-99.1 EX-99.1
  • 01.14.2025 - 8-K Current report

MOUNTAIN VIEW, Calif.,Nov. 19, 2024(GLOBE NEWSWIRE) --Iridex Corporation(Nasdaq: IRIX), a worldwide leader providing innovative and versatile laser-based medical systems, delivery devices, and procedure probes for the treatment of glaucoma and retinal diseases, today confirms that Local Coverage Determination (LCD) L37531, relating to Micro-Invasive Glaucoma Surgery (MIGS), was adopted as scheduled and will be effective for services performed on or afterNovember 17, 2024. The Company has previously reported that it believes the reimbursement limitations created by the new LCD has potential to significantly increase physician interest in and use of Iridex’s advanced laser-based treatments for glaucoma.

The new LCD clarifies that treatments performed using Iridex’s laser consoles and probes are not MIGS procedures, and thus, Iridex’s Cyclo G6®product family is unaffected by the new reimbursement limitations. Iridex’s proprietaryMicroPulse®and Continuous Wave laser therapies for glaucoma have been adopted by physicians around the globe as effective tools for managing and slowing the progression of glaucoma. Currently,Iridexsells more than 50,000 Cyclo G6 probes per year.

“In addition to creating some reimbursement advantages for Iridex’s glaucoma treatments inthe United States, the LCD creates opportunity to capture more physician attention to the significant clinical benefits of our products, particularly MicroPulse Transscleral Laser Therapy (MPTLT),” saidKevin LaMarche, Iridex’s Senior Director of Clinical Affairs. “Our laser procedures are noninvasive, repeatable, and can be utilized to treat patients across a far broader range of glaucoma’s progression, whether before, after, or even coincident to MIGS procedures.”

Nathan M Radcliffe, MD, ofNew York Eye and Ear Infirmary, commented, “Glaucoma is a non-curable disease. It is important that we have coverage for as many glaucoma treatments as possible. Transscleral Cyclophotocoagulation (TSCPC) is one of the very few glaucoma procedures that can be utilized in several disease states and almost all glaucoma types. Thousands of patients could have faced permanent blindness were this procedure limited by coverage.”

Brian A Francis, MD, Associate Professor of Ophthalmology at theDoheny Eye Institute, added, “I am encouraged that TSCPC remains unaffected by the recent glaucoma LCD. TSCPC is a valuable and versatile laser therapy within the glaucoma treatment paradigm.”

The final LCD, L37531, which went into effect onNovember 17, 2024, provides the following reimbursement limitations:

  1. MIGS is not considered a first line treatment for mild-moderate glaucoma.
  2. A combination of a surgical MIGS procedure and an aqueous shunt cannot be performed at the same time of service in the same eye.
  3. Phacoemulsification/intraocular lens placement performed with a combination of MIGS procedures, (e.g., cataract + stent + canaloplasty or goniotomy) at the same time of service in the same eye is non-covered.

Patrick Mercer, Iridex’s CEO, commented on the implications of the LCD for physicians treating glaucoma, “The community has been focused on pursuing more MIGS procedures, even to the point of stacking one form of treatment on top of another. The LCD appears designed to end this, and physicians evaluating treatment options will increasingly look for non-MIGS procedures, such as Iridex’sMicroPulseand Continuous Wave TLT, as they seek to mitigate progression of the disease.”

Mr. Mercercontinued, “At the recentAmerican Academy of Ophthalmology(AAO) conference inChicago, we saw significant anecdotal evidence that physicians already appreciate the increased role Iridex’s Cyclo G6 product family will play in their practices. We observed a steady stream of physicians visiting our booth and participating in our wet lab trainings that initiated discussion with our clinical and sales representatives on their intention to increase the number ofMicroPulseand Continuous Wave TLT procedures they will perform. We are very encouraged by these developments,”Mr. Mercerconcluded.

AboutIridex Corporation

Iridex Corporationis 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 proprietaryMicroPulse®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.Iridexproducts are sold inthe United Statesthrough a direct sales force and internationally primarily through a network of independent distributors into more than 100 countries. For further information, visit theIridexwebsite atwww.iridex.com.

MicroPulse®is a registered trademark ofIridex Corporation, Inc.inthe United States,Europeand other jurisdictions. © 2024Iridex Corporation. All rights reserved.

Safe Harbor StatementThis 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 theSecurities and Exchange CommissiononNovember 12, 2024. Forward-looking statements contained in this announcement are made as of this date and will not be updated.

Investor Relations ContactPhilip TaylorGilmartin Groupinvestors@iridex.com

Primary Logo

Source: IRIDEX Corporation

Please be aware that the following content has been generated by an AI system and may contain errors, inconsistencies, or outdated information. It is provided as-is without any warranties or guarantees of accuracy. We strongly recommend using this content as a starting point for further research and consultation with relevant experts or authorities. We disclaim any liability for damages or losses resulting from the use or reliance on this content.Please note that this is a beta version of the Gravity Analytica LLC’s AI Service which isstill undergoing final testing before its official release. Theplatform, its software and all content found on it are provided on an“as is” and “as available” basis. Gravity Analytica LLC does not give any warranties,whether express or implied, as to the suitability or usability of thisservice, webpage, or its software or any of its content.Should you encounter any bugs, glitches, lack of functionality orother problems on the website, please let us know immediately so wecan rectify these accordingly. Your help in this regard is greatlyappreciated! You can write to us at this addressteam@gravityanalytica.com