Sight Sciences Announces Positive Results and Primary Endpoint Successfully Met in SAHARA, a Randomized Controlled Clinical Trial Comparing Interventional Eyelid Procedures Enabled by TearCare® Technology to Restasis¹ for the Treatment of Dry Eye
20 Julho 2023 - 9:30AM
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 six-month results
from the SAHARA randomized controlled trial (RCT). The trial
successfully met its primary endpoint and the data reported
statistically significant improvements as compared to Restasis eye
drops for the treatment of dry eye disease. These results will be
presented in greater detail at the American Academy of Optometry’s
annual meeting in October 2023.
SAHARA Phase I Results:
- The SAHARA trial achieved its
primary six-month endpoint, demonstrating the superiority of
interventional eyelid procedures enabled by TearCare over Restasis
eyedrops in the improvement of tear break up time (TBUT), a key
measure of aqueous retention, tear stability and the tear film’s
ability to protect the ocular surface.
- The SAHARA trial also observed that
procedures enabled by TearCare were non-inferior to Restasis
eyedrops in Ocular Surface Disease Index (OSDI), which was the
co-primary six-month endpoint.
- Throughout the study,
interventional eyelid procedures with TearCare demonstrated
clinically and statistically significant improvements of every
endpoint and at every measurement interval: one week, one month,
three months, and six months. Endpoints assessed include TBUT,
meibomian gland score, corneal staining, and conjunctival staining.
Symptoms endpoints include two commonly used patient-reported
questionnaires: Ocular Surface Disease Index (OSDI) and Symptom
Assessment in Dry Eye (SANDE).
“At each measurement interval over the initial
six-month study period, subjects in the TearCare cohort exhibited
statistically significant improvement in all key signs and
symptoms,” remarked Brandon Ayres, MD, FAAO, Co-Director Cornea
Fellowship Program, Wills Eye Hospital and a Principal Investigator
of Sahara. “As we hypothesized, the data from the SAHARA trial
suggests that interventional eyelid procedures enabled by TearCare
technology help directly address the root cause of MGD and were
more effective than topical Restasis eyedrops in treating dry eye
on an aggregate basis across the endpoints measured in the SAHARA
trial. TearCare patients in the SAHARA trial benefitted from
improved function of obstructed and diseased meibomian glands and
experienced rapid improvement in dry eye symptoms. The results from
SAHARA support and build on the results from prior TearCare
technology trials. This landmark “device vs. drug” trial shows we
should change how we treat meibomian gland disease and dry eye in
the future.”
“We are extremely pleased with the successful
6-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 Restasis,” said
Paul Badawi, Co-Founder and Chief Executive Officer of Sight
Sciences. “We focus on developing interventional technologies and
procedures that can comprehensively address the underlying causes
of eye disease and this is evident in both our OMNI® technology for
primary open angle glaucoma as well as our TearCare technology for
meibomian gland disease. SAHARA demonstrates the rigor we embrace
in designing clinical trials to establish the clinical value of our
products and procedures.”
TearCare is intended to help restore healthy
function to diseased meibomian glands by removing obstructions
interfering with meibum production and outflow. SAHARA is the first
of its kind head-to-head, “device versus drug” RCT designed to
compare the effectiveness of interventional eyelid procedures
enabled by TearCare to twice daily Restasis prescription eyedrops
(cyclosporine ophthalmic emulsion, 0.05%). In this trial, 345
subjects at 25 sites in 14 states were randomized 1:1 between
TearCare and Restasis groups. To reduce the potential for bias,
physicians evaluating patients were masked regarding subject
treatment groups.
SAHARA was designed to challenge existing
treatment paradigms by focusing physicians’ attention on
restorative procedures that address the underlying cause of
meibomian gland disease (MGD) and demonstrate the clinical benefits
of procedural dry eye intervention compared to prescription dry eye
eyedrops.
Over 17 million Americans are diagnosed with dry
eye disease and studies have shown that MGD is associated with up
to 86% of dry eye disease³. Currently, over the counter and
prescription eyedrops are the dominant treatment for dry eye with
costs to payors and patients exceeding $2 billion annually⁴.
Eyedrops do not address obstructed meibomian glands, the root
underlying cause of MGD. Sight Sciences designed its TearCare
technology and its comprehensive interventional eyelid procedure to
safely and effectively treat the underlying obstructive causes of
MGD.
An abstract of Phase 1 results from SAHARA has
been accepted by the American Academy of Optometry for presentation
at its annual meeting in October. Sight Sciences plans to submit
the findings from SAHARA for publication in peer-reviewed journals
in the coming months. In the next phase of the SAHARA study,
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. Final results from SAHARA are expected
by 2025.
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 is a trademark of Sight Sciences.© 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 or during the
earnings call 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 disclosure, anticipated SAHARA patient follow-up, how
the SAHARA trial shows we should change how we treat meibomian
gland disease and dry eye in the future, and estimated timing for
disclosure of final SAHARA trial results. 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 Hannah
JenkinsRHMM Inc.903.340.4278pr@SightSciences.com
Investor contact:Philip
TaylorGilmartin
Group415.937.5406Investor.Relations@Sightsciences.com
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1 Restasis® is a
trademark of Allergan™ an AbbVie company 2 Miljanovic B. et.
al., Impact of Dry Eye Syndrome on Vision-related Quality of Life.
Am. J. Ophthalmol. 2007; 143(3): 409-4153 Lemp MA, Crews LA, Bron
AJ, et al. Distribution of aqueous-deficient and evaporative dry
eye in a clinic-based patient cohort: a retrospective study.
Cornea. 2012;31(5):472-478.4 Market Scope 2022 Dry Eye Products
Report. |
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