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
publication of the twelve-month results from the SAHARA trial.
Patients previously treated with Restasis®
(cyclosporine ophthalmic emulsion 0.05%) prescription eyedrops
(“Restasis”) had additional clinically meaningful improvements in
the signs and symptoms of dry eye disease (“DED”) when crossed over
to TearCare. These improvements persisted for six months through
month twelve without continued Restasis use.
“Phase 2 of the RCT again demonstrates the
clinical effectiveness of TearCare. It also shows that
effectiveness appears to be the same whether or not a patient has
had prior treatment with Restasis, demonstrating that similar
results could be expected when TearCare is used as a primary or
secondary treatment for DED,” said Paul Badawi, Co-Founder and
Chief Executive Officer of Sight Sciences.
Phase 1 of the SAHARA RCT included 345 subjects
at 19 sites in 11 states randomized 1:1 to either TearCare or
Restasis1. In Phase 2 of the SAHARA RCT, 163 patients who had been
randomized and treated with Restasis during phase 1 were crossed
over to TearCare at the six-month visit and followed for six months
through Month 12 of the study.
Data from the first six months of the SAHARA RCT
demonstrated that TearCare, an interventional eyelid procedure for
DED, was superior at all measured time points to twice daily use of
Restasis for the improvement of tear break up time (“TBUT”), the
trial’s primary dry eye signs endpoint and a key measure of tear
stability1. TearCare was superior to Restasis in multiple other
objective measures of dry eye, and demonstrated clinically
meaningful improvements in several symptoms that matched or
surpassed Restasis at all measured time points.
The aim of phase 2, undertaken in months six
through twelve, was to demonstrate that cessation of Restasis
followed by a single TearCare procedure would result in improved
signs and symptoms for patients beyond what was achieved with six
months of Restasis.
“These data demonstrate superior results with a
dry eye treatment technology that is not reliant on patient
adherence and supports the case for prioritizing interventional eye
lid treatment over a prescription-based approach,” said Brandon
Ayres, MD, Co-Director of the Cornea Fellowship Program at Wills
Eye Hospital and a Principal Investigator for the SAHARA RCT.
SAHARA RCT Twelve-Month Phase 2
Results:
- The study reports TBUT improved by
1.1 seconds three months after cross-over to TearCare and
improvement persisted (0.6 seconds) at month twelve, six months
later. Both timepoints were statistically significantly better than
the cross-over baseline (p<.001).
- Ocular Surface Disease Index
(“OSDI”) had small, non-statistically significant decreases at
three and six months after cessation of Restasis and a single
TearCare treatment. In contrast, Symptoms Assessment in Dry Eye
(“SANDE”) scores showed statistically significant improvement after
the cross over to TearCare. Eye Dryness Scores (“EDS”) also showed
improvement after cross-over at month 9 (p=.003), however, did not
reach statistical significance at month 12.
- Statistically significant
improvements in all other measures of signs following cross-over to
TearCare were observed at month nine and month twelve (three and
six months after TearCare treatment), except for STS (not measured
at month nine), which was numerically better by an average 1.0
second, but not statistically better (p=0.08).
- Mean OSDI, SANDE, and EDS for the
cross-over patients closely matched the means observed at month six
for the TearCare treatment group.
- TBUT, meibomian gland secretion
score (“MGSS”), meibomian glands yielding clear liquid score
(“MGYCS”), corneal and conjunctival staining scores, and STS all
improved and closely approximated the six-month TearCare values
from phase 1. Meibomian glands yielding any liquid score (“MGYLS”)
showed improvement (p<.001 vs. month six) but was intermediate
between the six months values for Restasis and TearCare.
Table 1. Ocular signs outcomes.
Ocular Symptom Parameters, mean (SD) |
Study BaselineN=346 |
Month 6 Cross-over Visit
N=326 |
Pa(vs. BL) |
Month 9 |
Pa(vs. M6) |
Month 12 |
Pa(vs. M6) |
TBUT (sec) |
4.36 (1.2) |
5.6 (2.6) |
<.001 |
6.6 (3.2) |
<.001 |
6.1 (2.8) |
<.001 |
MGSS |
7.1 (3.2) |
13.3 (8.2) |
<.001 |
17.4 (8.8) |
<.001 |
16.1 (9.0) |
<.001 |
No. of MGYLS (n) |
1.2 (1.4) |
4.1 (4.0) |
<.001 |
5.8 (4.7) |
<.001 |
5.6 (4.8) |
<.001 |
No. of MGYCS (n) |
0.08 (0.38) |
0.76 (1.99) |
<.001 |
1.3 (2.7) |
<.001 |
1.0 (2.4) |
.044 |
Corneal staining score |
2.9 (2.7) |
2.0 (2.4) |
<.001 |
1.5 (1.9) |
.004 |
1.6 (2.2) |
.002 |
Conjunctival staining score |
3.6 (3.5) |
2.8 (3.2) |
<.001 |
2.0 (2.5) |
.001 |
1.9 (2.8) |
<.001 |
STS (mm) |
9.3 (3.1) |
11.0 (6.3) |
ns, .075 |
nm |
- |
12.0 (7.2) |
ns, .080b |
a Mann-Whitney rank sum test. b P<.001 vs
Study baseline.Month 9 and 12 visits are 3 and 6 months
post-cross-over from CsA to TC. OD and OS measurements
pooled.Abbreviations: BL, baseline; M6, month 6;
SD, standard deviation; TBUT, tear break-up time; MGSS, meibomian
gland secretion score; MGYLS, meibomian glands yielding any liquid
score; MGYCS, meibomian glands yielding clear liquid score; STS,
Schirmer tear score; ns, not statistically significant; nm, not
measured.
Table 1 shows the observed mean values for signs
at the end of phase 2 of the study for the Restasis cross-over
cohort.
As the SAHARA RCT continues into Phase 3, it
will provide long-term 2-year data for the durability and
procedural treatment effect of TearCare.
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, Jaime E. Dickerson Jr.,
PhD of Sight Sciences and University of North Texas Health Science
Center, and Tomasita Rodriguez of Sight Sciences.
Paper Reference: Ayers BD, Bloomenstein MR, Loh
J, Chester T, Saenz B, Echegoyen J, Kannarr SR, Rodriguez TC,
Dickerson JE Jr. Improved signs and symptoms of dry eye disease for
Restasis® patients following a single TearCare® treatment: phase 2
of the SAHARA study. Clin Ophthalmol. 2024;18:1525-1534. doi:
10.2147/OPTH.S464379
About Sight Sciences
Sight 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; 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. For more information, visit www.sightsciences.com.
Sight Sciences and TearCare are trademarks 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. Restasis is a registered
trademark of Allergan, an AbbVie company.
© 2024 Sight Sciences. All rights reserved.
03/2024 TC-3166-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. 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 potential
expected TearCare efficacy when it is used as a primary or
secondary treatment for DED; the case for prioritizing
interventional treatment over a prescription-based approach; and
conduct of the next phase of the SAHARA trial. 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
contactpr@SightSciences.com Investor
contact:Philip TaylorGilmartin
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1. 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.
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