Sight Sciences Two Year Multicenter Study Results Show Sustained Reductions in Both Intraocular Pressure (IOP) and Glaucoma Medication Use in Mild-Moderate Primary Open Angle Glaucoma Patients Treated with a Procedure Enabled with the OMNI® Surgical Syste
23 Maio 2023 - 9:30AM
Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare
technology company focused on creating innovative solutions
intended to transform care and improve patients' lives, today
announced the publication of two-year results of the ROMEO
(Retrospective, Observational, Multicenter, Evaluation of OMNI)
study in Clinical Ophthalmology. The longest multicenter study of
the OMNI® Surgical System technology to date in both standalone and
combination-cataract surgery demonstrated that the significant
reductions in IOP and medication usage observed at 12 months were
also witnessed at 24 months. In addition, there were no serious or
unanticipated adverse events during the length of the two-year
study.
"This longer-term data set representing patients treated at
multiple centers throughout the country both at the time of
cataract surgery and as a standalone treatment should give eye
surgeons even greater confidence about the safety and durability of
efficacy of the OMNI Surgical System technology," said Blake
Williamson, MD, of The Williamson Eye Center in Baton Rouge, LA,
and a principal investigator of the study. "Knowing that OMNI
maintains effectiveness through two-years, and beyond, is very
reassuring, not only to me, but also to my patients."
Sites participating in this extension study accounted for 86
percent of eyes enrolled in the original ROMEO study from seven
multi-specialty ophthalmology practices in six states (Arkansas,
California, Kansas, Louisiana, Missouri, and New York). Patients
with mild-moderate glaucoma received outflow restorative procedures
enabled with the OMNI Surgical System technology either at the time
of cataract surgery (n = 43) or as a standalone treatment (n = 29).
Patients were divided into high baseline IOP (pre-operative IOP
> 18 mmHg, n = 34) and low baseline IOP cohorts (pre-operative
IOP ≤ 18 mmHg, n = 38). Average IOP in the high baseline IOP cohort
fell 31% (from 21.9 mmHg to 15.2 mmHg) at two years, which included
an average reduction of 28% among combination cataract patients (n
= 17) and an average reduction of 33% among standalone patients (n
= 17). The study also observed a 33% reduction in medication usage
on average among all patients at 24 months.
"This newest two-year follow-up data from the ROMEO study
demonstrates that restorative outflow procedures with our OMNI
technology continue to provide consistent and long-term lowering of
IOP and glaucoma medication use when performed at the time of
cataract surgery and as a standalone treatment," said Paul Badawi,
co-founder and CEO of Sight Sciences. "We plan to share additional
clinical data that will further illustrate the long-term benefits
of our OMNI technology over the coming years."
The OMNI Surgical System enables surgeons to provide minimally
invasive, implant-free surgery to reduce intraocular pressure (IOP)
in adults with primary open-angle glaucoma. The procedure intends
to restore outflow by targeting all three known points of
resistance in the aqueous outflow system: the trabecular meshwork,
Schlemm's canal, and the collector channels. It can be used before,
in combination with, or following cataract surgery.
The study, Canaloplasty and Trabeculotomy with the OMNI System
in Patients with Open-Angle Glaucoma: Two-Year Results from the
ROMEO Study, was published this month in Clinical Ophthalmology can
be found at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10086214.
About Sight SciencesSight Sciences is an
eyecare technology company focused on developing and
commercializing innovative solutions intended to transform care and
improve patients' lives. Using minimally invasive or non-invasive
approaches to target the underlying causes of the world's most
prevalent eye diseases, Sight Sciences seeks to create more
effective treatment paradigms that enhance patient care and
supplant conventional outdated approaches. The Company's OMNI®
Surgical System is a minimally invasive glaucoma surgery (MIGS)
technology indicated to reduce intraocular pressure in adult
patients with primary open-angle glaucoma (POAG), the world's
leading cause of irreversible blindness. The SION™ Surgical
Instrument is a bladeless, manually operated device used in
ophthalmic surgical procedures to excise trabecular meshwork. In
addition, the Company's TearCare® System technology is 510(k)
cleared in the United States for the application of localized heat
therapy in adult patients with evaporative dry eye disease due to
meibomian gland dysfunction (MGD), enabling office-based clearance
of gland obstructions by physicians to address the leading cause of
dry eye disease.
Visit SightSciences.com for more information.
About the OMNI Surgical SystemThe OMNI®
Surgical System technology is a handheld, single-use therapeutic
device for minimally invasive glaucoma surgery (MIGS). OMNI allows
surgeons to access 360 degrees and three primary points of
resistance of an eye's diseased conventional outflow pathway
(trabecular meshwork, Schlemm's canal, and collector channels)
through a single clear corneal microincision.
OMNI's FDA-cleared indication is for canaloplasty (the
microcatheterization and viscodilation of Schlemm's canal) followed
by trabeculotomy (the cutting of trabecular meshwork) to reduce
intraocular pressure in adult patients with primary open-angle
glaucoma. OMNI has a CE Mark for the catheterization and
transluminal viscodilation of Schlemm's canal and the cutting of
trabecular meshwork to reduce intraocular pressure in adult
patients with open-angle glaucoma.
OMNI should not be used in any situations where the iridocorneal
angle is compromised or has been damaged since it may not be
possible to visualize the angle or to properly pass the
microcatheter. Do not use the OMNI in patients with angle
recession; neovascular glaucoma; chronic angle closure;
narrow-angle glaucoma; traumatic or malignant glaucoma; or narrow
inlet canals with plateau iris or in quadrants with previous
MIGS implants.
OMNI technology is protected by a global patent portfolio
including 32 issued patents worldwide. OMNI is a registered
trademark of Sight Sciences.
Visit www.OMNIsurgical.com for more information.
© 2023 Sight Sciences. All rights reserved.
Media contact - GlaucomaCarmen CaricchioC2M
Grouppr@SightSciences.com
Investor contactPhilip TaylorGilmartin
Group415.937.5406Investor.Relations@Sightsciences.com
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