Iridex Announces Milestone Five-Year Study Confirms the Long-Term Effectiveness and Safety of MicroPulse Transscleral Cyclophotocoagulation for Glaucoma Management
2024年12月19日 - 6:05AM
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 ContactJoan
Stauferjstauffer@iridex.com
Investor Relations ContactPhilip Taylor
Gilmartin Groupinvestors@iridex.com
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