Sight Sciences Announces Presentation of Successful Phase I Results of the SAHARA Randomized Controlled Clinical Trial Comparing TearCare® to Restasis® for the Treatment of Dry Eye Disease at the American Academy of Optometry Annual Meeting
12 Outubro 2023 - 5:05PM
Sight Sciences, Inc. (Nasdaq: SGHT) (“Sight Sciences,” or the
“Company”), an eyecare technology company focused on developing and
commercializing innovative technology intended to transform care
and improve patients’ lives, today announced the presentation of
the full phase I results from the SAHARA randomized controlled
trial (“RCT”), demonstrating that interventional eyelid procedures
for dry eye disease enabled by TearCare technology (“TearCare”)
were superior at all measured time points to Restasis prescription
eyedrops (“Restasis”) for the improvement of tear break up time
(“TBUT”), the trial’s primary objective endpoint and a key measure
of aqueous retention, tear stability and the tear film’s ability to
protect the ocular surface. TearCare and Restasis also delivered
comparable clinically and statistically significant improvements at
every time point measured in patient reported outcomes measured by
Ocular Surface Disease Index (“OSDI”) scores, the trial’s primary
subjective endpoint.
These results were presented today at the
American Academy of Optometry’s annual meeting in New Orleans.
“Pharmaceutical intervention with Restasis has been the hallmark of
dry eye treatment since its introduction. The results of the SAHARA
RCT utilizing TearCare technology, which treats the root cause of
dry eye disease, should make us rethink our options for the optimal
treatment for dry eye,” remarked Dr. Bloomenstein, O.D., FAAO,
Director of Optometric Services, Schwartz Laser Eye Center, and a
Principal Investigator for the SAHARA clinical trial. “Knowing we
can achieve superior dry eye results with a procedure that also
reduces concerns for daily prescription eyedrop patient compliance
and adherence should make my colleagues in eyecare, as well as
insurance providers, consider providing our patients access to
TearCare as an efficacious and durable interventional dry eye
treatment.”
The study also demonstrated that TearCare was
superior to Restasis in several other important objective signs of
dry eye and delivered statistically significant improvements from
baseline in all other measures that were at least as good as
Restasis at all measured time points. SAHARA included 345 subjects
at 25 sites in 14 states randomized 1:1 between TearCare and
Restasis groups. Results are expected to be published in a
peer-reviewed journal in late 2023.
SAHARA Phase I Complete Results:
- TearCare was superior to Restasis
in the objective improvement of TBUT at every time point measured
(one week, one month, three months, and six months). Patients
receiving TearCare treatments exhibited statistically significant
improvements in TBUT from baseline that increased from a 1.5-second
improvement from baseline at one week to a 2.5-second improvement
from baseline at six months.
- TearCare was also superior to
Restasis in three other objective functional assessments of the
underlying health of the meibomian glands, including meibomian
gland secretion score, the number of glands yielding any liquid,
and the number of glands yielding clear liquid.
- On corneal and conjunctival health
improvements as measured by corneal and conjunctival staining,
patients in the TearCare and Restasis groups demonstrated
comparable statistically significant improvements at all time
points measured.
- TearCare and Restasis delivered
comparable statistically significantly improvements in tear
production, as measured by Schirmer Test. Restasis is indicated to
increase tear production in patients whose tear production is
presumed to be suppressed due to ocular inflammation associated
with keratoconjunctivitis sicca.
- TearCare and Restasis also
delivered comparable statistically significant clinical
improvements in OSDI scores, Symptoms Assessment in Dry Eye
(“SANDE”) scores, and Eye Dryness Scores (“EDS”), patient reported
outcomes to subjectively assess dry eye severity.
- Link to full presentation:
https://ssi.onl/sahara
TBUT Improvement from Baseline (seconds) |
|
|
TearCare |
Restasis |
P Value |
Week 1 |
1.50 |
0.74 |
0.0001 |
Month 1 |
1.64 |
1.05 |
0.0055 |
Month 3 |
1.91 |
1.32 |
0.0080 |
Month 6 |
2.51 |
1.62 |
<0.0001 |
OSDI Score Improvement from Baseline * |
|
TearCare |
Restasis |
Week 1 |
15.93 |
15.86 |
Month 1 |
16.47 |
16.77 |
Month 3 |
15.82 |
18.81 |
Month 6 |
19.76 |
19.71 |
* At all time points, both groups significantly
improved from baseline, P<0.0001
“We are extremely pleased with the successful
six-month results of the SAHARA RCT. The data from this trial
support our belief in the clinical superiority of interventional
eyelid procedures enabled by TearCare technology versus the most
commonly prescribed dry eye therapeutic,” said Paul Badawi,
Co-Founder and Chief Executive Officer of Sight Sciences. “We focus
on equipping our ophthalmic and optometric customers with
interventional technologies and procedures that can comprehensively
address the underlying causes of eye disease and restore
functionality, thereby elevating the standard of care. This is
evident in both our Trabeculocanalicular Outflow Restoration
procedure (“TCOR”) with OMNI technology for primary open-angle
glaucoma, as well as our focus on the functional restoration of the
meibomian glands with TearCare technology for evaporative dry eye.
The SAHARA trial demonstrates the rigor we embrace in designing
clinical trials to establish both the clinical and health economic
value of our products and procedures for all stakeholders.”
In Phase II of the SAHARA trial, subjects in the
Restasis cohort cease use of Restasis, receive an interventional
eyelid procedure with TearCare, and will be monitored for another
six months. Subjects in the TearCare cohort will receive additional
interventional eyelid procedures as necessary based on
pre-determined criteria over an additional 18 months (24 months
total study period) to measure the durability of procedural
treatment effect.
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 Company’s TearCare
System technology is 510(k) cleared 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 office-based 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.
For more information, visit
www.sightsciences.com.
OMNI and TearCare are registered trademarks of
Sight Sciences.SION and TCOR are trademarks of Sight
Sciences.Restasis is a trademark of Allergan, an AbbVie
company.
© 2023 Sight Sciences. All rights reserved.
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. 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 include
information concerning timing of SAHARA trial clinical data
publication; rethinking options for the treatment of dry eye;
knowledge that the achievement through the use of TearCare
technology of superior dry eye results via an in-office procedure
that addresses medication usage compliance should cause eyecare
professionals and insurance providers to consider providing
patients with access to TearCare as an efficacious and durable
interventional dry eye treatment; and, conduct of Phase II of the
SAHARA study. 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 we believe that these forward-looking statements are based
on reasonable assumptions at the time they are made, you should be
aware that many factors could affect our business, results of
operations and financial condition and could cause actual results
to differ materially from those expressed in the forward-looking
statements. These forward-looking statements are subject to and
involve numerous risks, uncertainties and assumptions, including
those discussed under the caption “Risk Factors” in our filings
with the U.S. Securities and Exchange Commission, as may be updated
from time to time in subsequent filings, and you should not place
undue reliance on these statements. These cautionary statements are
made only as of the date of this press release. We undertake 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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