Sight Sciences Announces Publication of a New Analysis from The ROMEO Study Showing Meaningful Pressure and Medication Reductions Achieved with OMNI® Across Mild, Moderate, and Advanced Glaucoma
28 Maio 2024 - 9:30AM
Sight Sciences, Inc. (Nasdaq: SGHT) ("Sight Sciences" or the
"Company"), an eyecare technology company focused on developing and
commercializing innovative, interventional technologies intended to
transform care and improve patients' lives, today announced the
results as published in the journal Clinical Ophthalmology of a new
analysis of the ROMEO (Retrospective, Observational, Multicenter
Evaluation of OMNI) study data. This new analysis evaluated the
association between the severity of glaucoma and the intraocular
pressure ("IOP") and medication outcomes for patients treated with
the OMNI Surgical System ("OMNI"). OMNI enables a procedure
intended to restore aqueous outflow of glaucomatous eyes by
addressing the three areas of outflow resistance associated with
the disease.
The findings suggest that ab interno
canaloplasty coupled with trabeculotomy using OMNI was as effective
at lowering IOP and reducing medication usage in advanced glaucoma
patients as it was in mild and moderate glaucoma patients. This
data challenges the belief that advanced disease stage is a barrier
to successful treatment outcomes for minimally invasive glaucoma
surgery ("MIGS").
"There had been some debate about the efficacy
of MIGS in advanced glaucoma patients, with speculation that
prolonged disease may cause irreversible harm to the distal outflow
pathway," said Dr. Jaime E. Dickerson, Jr., Vice President of
Medical and Clinical Affairs at Sight Sciences. "The current study
suggests that treatment with OMNI technology, which has a strong
safety profile and proven durability, is still effective in
patients with more extensive visual field damage."
ROMEO was an Institutional Review Board ("IRB")
approved retrospective case series conducted at eleven
ophthalmology practices in the United States. Participants were
mainly primary open-angle glaucoma patients (122 of 129, or 95%)
who had undergone the implant-free OMNI procedure, which has been
cleared by the FDA for canaloplasty followed by ab interno
trabeculotomy to reduce intraocular pressure in adult patients with
primary open-angle glaucoma, either combined with cataract surgery
or as a standalone procedure.
Eyes were categorized based on visual field mean
deviation ("MD"), with participants assigned to a group with
severity rated as mild (n=79, median MD -2.7 dB), moderate (n=42,
median MD -8.0 dB) or advanced (n=6, median MD -13.3). The study
compared outcomes at 12 months.
Key findings reported in the study
include:
- Significant reductions in both IOP
and IOP-reducing medications were observed.
- The majority of eyes (70%)
experienced a reduction in IOP at Month 12, with most achieving
levels of 18 mmHg or less (92%).
- The percentage of IOP reduction was
consistent across severity groups, with month 12 mean IOP ranging
between 14 mmHg and 16 mmHg.
- Medication reductions were observed
across all severity groups, with the majority of patients showing a
reduction of at least 1 medication (50% to 69%), indicating the
effectiveness of the treatment approach.
- Regression analysis found no
significant relationship between month 12 IOP and visual field
loss, suggesting treatment outcomes were consistent irrespective of
disease severity.
"Clinical trials and real-world results continue to demonstrate
favorable OMNI treatment outcomes across different stages of
glaucoma," said Paul Badawi, Co-Founder and CEO of Sight Sciences.
"These findings reinforce our dedication to offering effective
treatment options for glaucoma patients at every stage of the
disease and also fuel our initiatives to continue reimagining
eyecare with transformative technology and an interventional
mindset."
Authors and affiliations: Jaime
E. Dickerson Jr., PhD; Alison E. Harvey, PhD; and Reay H. Brown,
MD, all from Sight Sciences.
Paper Reference: Jamie E.
Dickerson, Alison E. Harvey, Reay H. Brown, Ab Interno Canaloplasty
and Trabeculotomy Outcomes for Mild, Moderate, and Advanced
Open-Angle Glaucoma: A ROMEO Analysis, Clinical Ophthalmology,
2024:18
About Sight SciencesSight
Sciences is an eyecare technology company focused on developing and
commercializing innovative and interventional 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 an implant-free glaucoma surgery technology (i)
indicated in the United States to reduce intraocular pressure in
adult patients with primary open-angle glaucoma ("POAG"); and (ii)
CE Marked for the catheterization and transluminal viscodilation of
Schlemm's canal and cutting of the trabecular meshwork to reduce
intraocular pressure in adult patients with open-angle glaucoma.
Glaucoma is the world's leading cause of irreversible blindness.
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") when used in conjunction with manual
expression of the meibomian glands, enabling clearance of gland
obstructions by physicians to address the leading cause of dry eye
disease. The Company's SION® Surgical Instrument is a manually
operated device used in ophthalmic surgical procedures to excise
trabecular meshwork. Visit sightsciences.com for more
information.
Sight Sciences is a trademark of Sight Sciences registered in
the United States. OMNI and SION are trademarks of Sight Sciences
registered in the United States, European Union and other
territories.
© 2024 Sight Sciences. All rights reserved. 05/2024
OM-3212-US.v1
Forward-Looking StatementsThis press release,
together with other statements and information publicly
disseminated by the Company, contains certain forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended, which statements are subject to considerable
risks and uncertainties. The Company intends such forward-looking
statements to be covered by the safe harbor provisions for
forward-looking statements contained in the Private Securities
Litigation Reform Act of 1995 and includes this statement for
purposes of complying with these safe harbor provisions. Any
statements made in this press release that are not statements of
historical fact, including statements about our beliefs and
expectations, are forward-looking statements and should be
evaluated as such. Forward-looking statements herein include,
without limitation, statements concerning the clinical outcomes and
our initiatives to continue reimagining eyecare with transformative
technology and an interventional mindset. These statements often
include words such as "anticipate," "expect," "suggests," "plan,"
"believe," "intend," "estimates," "targets," "projects," "should,"
"could," "would," "may," "will," "forecast" and other similar
expressions. We base these forward-looking statements on our
current expectations, plans and assumptions that we have made in
light of our experience in the industry, as well as our perceptions
of historical trends, current conditions, expected future
developments and other factors we believe are appropriate under the
circumstances at such time. Although management believes these
forward-looking statements are based upon reasonable assumptions at
the time they are made, management cannot guarantee their accuracy
or completeness. Forward-looking statements are subject to and
involve risks, uncertainties and assumptions that may cause the
Company's actual results, performance or achievements to be
materially different from any future results, performance, or
achievements predicted, assumed or implied by such forward-looking
statements. Some of the risks and uncertainties that may cause
actual results to materially differ from those expressed or implied
by these forward-looking statements are discussed under the caption
"Risk Factors" in the Company's filings with the SEC, as may be
updated from time to time in subsequent filings. These cautionary
statements should not be construed by you to be exhaustive and are
made only as of the date of this press release. Sight Sciences
undertakes no obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by applicable law.
Media
contact: pr@SightSciences.com
Investor contact:Philip TaylorGilmartin
Group415.937.5406Investor.Relations@SightSciences.com
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