Iridex Comments on Changing Glaucoma Reimbursement Landscape
Iridex (Nasdaq: IRIX) confirms the adoption of Local Coverage Determination (LCD) L37531 for Micro-Invasive Glaucoma Surgery (MIGS), effective November 17, 2024. The new LCD clarifies that Iridex's laser-based treatments are not MIGS procedures and remain unaffected by new reimbursement limitations. The company's Cyclo G6® product family, which currently sells over 50,000 probes annually, offers noninvasive, repeatable treatments across various stages of glaucoma progression. The LCD's restrictions on MIGS procedures are expected to increase physician interest in Iridex's laser-based alternatives.
Iridex (Nasdaq: IRIX) conferma l'adozione della Determinazione Locale di Copertura (LCD) L37531 per la Chirurgia Glaucomatosa Micro-Invasiva (MIGS), a partire dal 17 novembre 2024. La nuova LCD chiarisce che i trattamenti basati su laser di Iridex non sono procedure MIGS e rimangono indenni dalle nuove limitazioni di rimborso. La famiglia di prodotti Cyclo G6® dell'azienda, che attualmente vende oltre 50.000 sonde all'anno, offre trattamenti non invasivi e ripetibili in diverse fasi della progressione del glaucoma. Si prevede che le restrizioni della LCD sulle procedure MIGS aumenteranno l'interesse dei medici per le alternative basate su laser di Iridex.
Iridex (Nasdaq: IRIX) confirma la adopción de la Determinación de Cobertura Local (LCD) L37531 para la Cirugía de Glaucoma Micro-Invasiva (MIGS), efectiva a partir del 17 de noviembre de 2024. La nueva LCD aclara que los tratamientos basados en láser de Iridex no son procedimientos MIGS y permanecen inalterados por las nuevas restricciones de reembolso. La familia de productos Cyclo G6® de la compañía, que actualmente vende más de 50,000 sondas anualmente, ofrece tratamientos no invasivos y repetibles en diversas etapas de la progresión del glaucoma. Se espera que las restricciones de la LCD sobre los procedimientos MIGS aumenten el interés de los médicos en las alternativas basadas en láser de Iridex.
Iridex (Nasdaq: IRIX)는 2024년 11월 17일부터 유효한 미세침습 녹내장 수술(MIGS)에 대한 지역적 보장 결정(LCD) L37531의 채택을 확인했습니다. 새로운 LCD는 Iridex의 레이저 기반 치료가 MIGS 절차에 해당하지 않으며 새로운 환급 제한의 영향을 받지 않음을 명확히 하고 있습니다. 현재 연간 50,000개 이상의 탐침을 판매하는 Cyclo G6® 제품군은 녹내장 진행의 다양한 단계에서 비침습적이고 반복 가능한 치료를 제공합니다. LCD의 MIGS 절차에 대한 제한은 의사들이 Iridex의 레이저 기반 대안에 관심을 가지도록 증가시킬 것으로 예상됩니다.
Iridex (Nasdaq: IRIX) confirme l'adoption de la Détermination de Couverture Locale (LCD) L37531 pour la Chirurgie Glaucomateuse Micro-Invasive (MIGS), effective à partir du 17 novembre 2024. La nouvelle LCD clarifie que les traitements à base de laser d'Iridex ne sont pas des procédures MIGS et ne sont pas affectés par les nouvelles limitations de remboursement. La gamme de produits Cyclo G6® de l'entreprise, qui vend actuellement plus de 50 000 sondes par an, offre des traitements non invasifs et répétables à différents stades de la progression du glaucome. Les restrictions de la LCD sur les procédures MIGS devraient accroître l'intérêt des médecins pour les alternatives basées sur le laser d'Iridex.
Iridex (Nasdaq: IRIX) bestätigt die Annahme der lokalen Leistungsbestimmung (LCD) L37531 für mikroinvasive Glaukomchirurgie (MIGS), die ab dem 17. November 2024 wirksam ist. Die neue LCD stellt klar, dass die laserbasierten Behandlungen von Iridex keine MIGS-Verfahren sind und nicht von den neuen Erstattungsbeschränkungen betroffen sind. Die Produktfamilie Cyclo G6® des Unternehmens, die derzeit über 50.000 Sonden jährlich verkauft, bietet nicht-invasive, wiederholbare Behandlungen in verschiedenen Stadien der Glaukomprogression. Die Einschränkungen der LCD für MIGS-Verfahren werden voraussichtlich das Interesse der Ärzte an den laserbasierten Alternativen von Iridex steigern.
- Company's treatments are exempt from new MIGS reimbursement limitations
- Current sales volume exceeds 50,000 Cyclo G6 probes annually
- Expected increase in physician interest due to MIGS restrictions
- Strong physician engagement and interest observed at AAO conference
- None.
Insights
The new LCD reimbursement policy represents a significant shift in the glaucoma treatment landscape, creating a notable competitive advantage for Iridex's non-MIGS laser treatments. The policy's restrictions on MIGS procedures - particularly limiting combination treatments and first-line use - positions Iridex's Cyclo G6® product family favorably in the market.
Key business implications include:
- Current scale of 50,000+ Cyclo G6 probes sold annually provides strong revenue base
- Broader treatment window across disease progression stages compared to MIGS
- Increased physician interest at AAO conference suggests potential market share growth
The reimbursement advantage and versatility of Iridex's solutions could drive increased adoption, particularly as physicians seek alternatives to restricted MIGS procedures. This regulatory change effectively reduces competition while enhancing Iridex's market position.
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 after November 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 proprietary MicroPulse® 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, Iridex sells more than 50,000 Cyclo G6 probes per year.
“In addition to creating some reimbursement advantages for Iridex’s glaucoma treatments in the 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),” said Kevin 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, of New 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 the Doheny 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 on November 17, 2024, provides the following reimbursement limitations:
- MIGS is not considered a first line treatment for mild-moderate glaucoma.
- A combination of a surgical MIGS procedure and an aqueous shunt cannot be performed at the same time of service in the same eye.
- 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’s MicroPulse and Continuous Wave TLT, as they seek to mitigate progression of the disease.”
Mr. Mercer continued, “At the recent American Academy of Ophthalmology (AAO) conference in Chicago, 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 of MicroPulse and Continuous Wave TLT procedures they will perform. We are very encouraged by these developments,” Mr. Mercer concluded.
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.
Investor Relations Contact
Philip Taylor
Gilmartin Group
investors@iridex.com
FAQ
How will the new LCD L37531 affect Iridex (IRIX) glaucoma treatments?
What are the current sales volumes for Iridex (IRIX) Cyclo G6 probes?
What are the key restrictions in the new LCD L37531 affecting MIGS procedures?
When did the new LCD L37531 for MIGS procedures take effect?
