The ViaLase Laser combines
state-of-the-art femtosecond laser technology with micron-level
image guidance to deliver the first femtosecond laser,
image-guided, high-precision trabeculotomy (FLigHT), marking a
pioneering advancement in glaucoma care
ViaLase is pleased to announce strategic
distribution partnerships with Teleon and
Global Surgical
Service in preparation for commercialization in select European
markets
ALISO VIEJO, Calif.,
July 30, 2024 /PRNewswire/
-- ViaLase, Inc., a clinical-stage medical technology
company focused on addressing unmet needs in the conventional
glaucoma treatment paradigm, today announced that it has received
CE (Conformité Européenne) Mark approval in the European Union (EU)
for its ViaLase® Laser* for the treatment of adult
patients with primary open-angle glaucoma (POAG).
The ViaLase Laser combines the precision of a femtosecond
laser and the accuracy of micron-level image guidance to deliver a
noninvasive glaucoma treatment called femtosecond laser,
image-guided, high-precision trabeculotomy, or FLigHT. This
technology addresses a major unmet need for patients who may
benefit from a non-pharmacologic, incision-free procedure without
compromising their therapeutic goals.
"The ViaLase Laser represents a monumental transformation in
interventional glaucoma care in its potential to deliver
surgery-like results without the need for opening the eye and thus,
reducing complications associated with more invasive, surgical
procedures," said Tibor Juhasz, PhD,
Founder and Chief Executive Officer, ViaLase, Inc. "Early clinical
data indicate that FLigHT is safe and effective at lowering
intraocular pressure (IOP). We look forward to working with our
distribution partners to bring this groundbreaking technology to
physicians and patients in Europe."
"We have good evidence that early, non-medical intervention
offers better long-term disease control and preservation of vision
– which is what matters most to patients. I'm delighted that
physicians and patients can soon benefit from the ViaLase Laser,
which brings a new level of imaging and precision to glaucoma care.
Furthermore, the patient's lens status has no bearing on their
ability to undergo FLigHT, expanding access to patients who
previously had limited treatment options," said Richard Lewis, MD, Chief Medical Officer,
ViaLase, Inc.
ViaLase anticipates a selective commercial rollout of the
ViaLase Laser in key markets later this year. The company has
established formal distributor partnerships with Global Surgical
Service (Spain and Portugal) and Teleon
Surgical (Germany and
Austria). Each organization has
deep ophthalmology experience and an established commercial
presence in their markets. These strategic partnerships will allow
for a timely and efficient rollout of the ViaLase Laser to
physicians and patients.
*The ViaLase Laser is not approved for use in the United States.
About Glaucoma
Glaucoma affects 76 million people
worldwide, a number that is expected to increase to 112 million by
2040, and is the second leading cause of irreversible blindness in
the world.1,2 Most forms of glaucoma are chronic and,
when left undetected or untreated, lead to irreversible vision
loss. Early detection and treatment are essential to protecting
against vision loss, which results when the optic nerve
deteriorates, leading to progressive loss of the field of vision.
Lowering IOP and thus reducing visual field progression is the only
proven glaucoma treatment today. The current treatment paradigm
typically begins with topical eye drops, then may advance to laser
therapy or minimally invasive glaucoma surgery (MIGS), before
resorting to invasive, traditional filtration surgery.
About ViaLase, Inc.
ViaLase, Inc. is a
globally-minded, venture capital-backed, clinical
stage medical technology company located in Aliso Viejo, CA. ViaLase is focused on
disrupting the conventional glaucoma treatment paradigm with the
introduction of a truly noninvasive, image-guided, femtosecond
laser treatment that enhances glaucoma patient care. With a
leadership team that has vast experience developing,
designing, manufacturing, and commercializing the first femtosecond
lasers for ophthalmic surgery for refractive and cataract
patients, ViaLase is now bringing that expertise and
innovation to glaucoma patients. ViaLase believes in collaborating
closely with health care providers, payers, societies, and patients
to inform our product development and commercial
activities with the goal of bringing this revolutionary
treatment to glaucoma patients across the globe. For more
information, visit www.ViaLase.com.
References
- World Health Organization. World report on vision: Executive
Summary
2019. https://iris.who.int/bitstream/handle/10665/328721/WHO-NMH-NVI-19.12-eng.pdf
- Tham YC, Xiang L, et al. Global Prevalence of Glaucoma and
Projections of Glaucoma Burden through 2040: A Systematic Review
and Meta-Analysis. Ophthalmology 2014; 121(11): 2081-2090.
https://www.sciencedirect.com/science/article/abs/pii/S0161642014004333
Any product/brand names and/or logos are trademarks of
ViaLase, Inc.
MEDIA CONTACT:
Michele
Gray
Gray Communications, LLC.
+1 (917) 449-9250
michele@mgraycommunications.com
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