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 .
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
加利福尼亞州山景城,2024年12月18日(GLOBE NEWSWIRE)——爲青光眼和視網膜疾病治療提供創新和多功能激光醫療系統和交付設備的全球領導者Iridex公司(納斯達克股票代碼:IRIX)今天宣佈發表一項具有里程碑意義的同行評審的眼科療法研究。這項研究強調了MicroPulse經鞏膜激光療法(TLT)(也稱爲經鞏膜環光凝術)在五年內在治療原發性和繼發性青光眼方面的持續安全性和有效性。這項研究由荷蘭馬斯特裏赫特大學眼科診所的羅納德·德克羅姆博士及其同事進行,是第一個評估如此長時間內MicroPulse tLT療效的研究。
該研究評估了2016年至2019年間治療的165只白內障前後眼睛,其中112隻眼睛完成了爲期五年的隨訪。治療是使用處於微脈衝模式的 Iridex Cyclo G6 激光器和最初的 MicroPulse P3 輸送設備進行的。結果表明,MicroPulse tLT顯著(p<0.001)降低了眼壓(IOP),平均爲32.5%,同時還使各種青光眼類型和嚴重程度的併發症發生率較低的IOP藥物顯著降低(p<0.005),併發症發生率較低。
德克羅姆博士說:「這些發現表明,MicroPulse tLT可以成爲侵入性切口青光眼手術的可行替代方案,尤其是在繼發性青光眼患者和切口手術可能具有挑戰性的患者中。」「它能夠持續降低IOP,同時將併發症降至最低,這使其成爲基本的治療選擇。」
此外,在五年的隨訪期內,只有38%的眼睛需要再治療。「接受再治療的患者取得了與最初接受治療的患者相似的成功水平,但併發症風險沒有顯著增加。」德克羅姆博士繼續說:「能夠安全地重複MicroPulse治療,同時繼續進行長期青光眼護理管理,而不必進行更具侵入性的青光眼手術,這對臨牀醫生和患者來說都是一個巨大的優勢!」
Iridex首席執行官帕特里克·默瑟評論說:「這是第一項經過同行評審的長期研究,它證明了MicroPulse tLT的安全性、有效性和可重複性。這項具有里程碑意義的研究支持了我們致力於提供創新的非切口解決方案的承諾,這些解決方案可以改善患者的預後,同時爲我們的投資者和客戶創造價值。」
關於 Iridex 公司
Iridex Corporation是爲眼科市場開發、製造和銷售創新的多功能激光醫療系統、輸送設備和耗材儀器的全球領導者。該公司專有的MicroPulse技術提供差異化治療方法,爲有針對性的威脅視力的眼部疾病提供安全、有效且經過驗證的治療方法。Iridex目前的產品線用於治療青光眼和糖尿病性黃斑水腫(DME)和其他視網膜疾病。Iridex產品通過直銷隊伍在美國銷售,在國際上主要通過獨立分銷商網絡銷售,銷往100多個國家。欲了解更多信息,請訪問 Iridex 網站,網址爲。
MicroPulse 是 Iridex Corporation, Inc. 在美國、歐洲和其他司法管轄區的註冊商標。2024 Iridex Corporation。版權所有。
安全港聲明
本公告包含經修訂的1933年《證券法》第27A條和經修訂的1934年《證券法》第21E條所指的前瞻性陳述,包括有關臨牀預期和商業趨勢、市場採用和擴張、價值最大化交易、對公司產品和業績的需求和利用以及預期銷量的陳述。該公司無法保證會代表股東完成任何價值最大化交易。這些陳述不能保證未來的表現,由於多種因素,實際業績可能與這些前瞻性陳述中描述的結果存在重大差異。請參閱我們於2024年11月12日向美國證券交易委員會提交的10-Q表季度報告中對這些風險和其他風險的詳細描述。本公告中包含的前瞻性陳述自該日起作出,不會更新。
媒體聯繫人
瓊·斯陶弗
jstauffer@iridex.com
投資者關係聯繫人
菲利普泰勒
吉爾馬丁集團
investors@iridex.com