Sight Sciences Announces the Publication of Successful Results of the SAHARA Randomized Controlled Clinical Trial Comparing TearCare® to Restasis® for the Treatment of Dry Eye Disease
18 Dicembre 2023 - 10:05PM
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 publication in
Clinical Ophthalmology of the six-month primary results from the
SAHARA randomized controlled trial (“RCT”).
“We are extremely pleased to have the successful
six-month results of the SAHARA RCT now published in a
peer-reviewed journal. The data from this trial support our belief
in the clinical efficacy of interventional eyelid procedures
enabled by TearCare technology versus the most commonly prescribed
dry eye therapeutic for meibomian gland dysfunction,” said Paul
Badawi, Co-Founder and Chief Executive Officer of Sight Sciences.
“We plan to now focus on sharing these results with Medicare and
commercial payors as we pursue fair and reasonable reimbursed
market access to our technology.”
The data generated in the SAHARA RCT
demonstrates that interventional eyelid procedures for dry eye
disease enabled by TearCare technology (“TearCare”) were superior
at all measured time points through 6 months to twice daily
Restasis® prescription eyedrops (“Restasis”) for the improvement of
tear break up time (“TBUT”), the trial’s primary dry eye signs
endpoint and a key measure of aqueous retention, tear stability and
the tear film’s ability to protect the ocular surface. "While
RESTASIS has been a longstanding staple in dry eye therapy, the
findings from the SAHARA RCT, highlighting the efficacy of TearCare
in addressing the underlying causes of evaporative dry eye,
encourage a reconsideration of prioritizing interventional
treatment over a prescription-based approach," remarked Brandon
Ayres, MD, Co-Director of the Cornea Fellowship Program at Wills
Eye Hospital and a Principal Investigator for the SAHARA clinical
trial.
TearCare was also superior to Restasis in
several other important objective signs of dry eye and delivered
statistically significant and clinically meaningful improvements
from baseline in all other measures that were at least as good as
Restasis at all time points. SAHARA included 345 subjects at 19
sites in 11 states randomized 1:1 to either TearCare or Restasis.
TearCare and Restasis delivered clinically comparable 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 symptoms endpoint.
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 as early as one week and
reaching a 2.4-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.
- TearCare and Restasis both
demonstrated comparable statistically significant improvements at
all time points measured for corneal and conjunctival staining, key
indicators of corneal and conjunctival health. TearCare and
Restasis delivered comparable statistically significant
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.
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 |
2.39 |
1.63 |
0.0006 |
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 |
19.52 |
19.68 |
* At all time points, both groups significantly
improved from baseline, P<0.0001
In the next phase 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. The Company expects publication of the
1-year crossover clinical results by year-end 2024.
Authors and affiliations: Dr. Brandon D Ayres MD
(Private Practice), Dr. Marc R Bloomenstein OD of Schwartz Laser
Eye Center, Dr. Jennifer Loh MD of Loh Ophthalmology Associates,
Dr. Thomas Chester OD of Cleveland Eye Clinic, Dr. Bobby Saenz OD
MS of Rosenberg School of Optometry and Lasik San Antonio, Dr.
Julio Echegoyen MD PhD of Gordon Schanzlin New Vision Institute,
Dr. Shane R Kannarr OD of Kannarr Eye Care, Dr. Victor L Perez MD
of Bascom Palmer Eye Institute, Miller School of Medicine,
University of Miami, Jaime E. Dickerson Jr., PhD of Sight Sciences
and University of North Texas Health Science Center, and Afua
Ohene-Nyako of Sight Sciences.
Paper Reference: Ayres BD et al. A Randomized, Controlled Trial
Comparing Tearcare® and Cyclosporine Ophthalmic Emulsion for the
Treatment of Dry Eye Disease (SAHARA). Clinical Ophthalmology
(2023) Volume 17 Pages 3925-3940.
https://www.dovepress.com/a-randomized-controlled-trial-comparing-tearcare-and-cyclosporine-opht-peer-reviewed-fulltext-article-OPTH
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.Restasis is a
registered 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 the
Company's plans to share SAHARA results with Medicare and
commercial payors to pursue reimbursement; conduct of the next
phase of the SAHARA trial, and estimated timeline for publication
of the 1-year SAHARA crossover clinical 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
pr@SightSciences.com
Investor contact:Philip TaylorGilmartin
Group415.937.5406Investor.Relations@Sightsciences.com
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