Sight Sciences Announces the Acceptance for Publication of GEMINI 2, a Three Year, Prospective, Multicenter Trial Demonstrating Sustained, Significant IOP and Medication Reductions Enabled with the OMNI® Surgical System Technology
08 Dezember 2023 - 2:05PM
Sight Sciences, Inc. (Nasdaq: SGHT) (“Sight Sciences”), an eyecare
technology company focused on developing and commercializing
innovative technology intended to transform care and improve
patients’ lives, today announced the acceptance for publication in
Clinical Ophthalmology of the prospective, multi-center, three-year
GEMINI 2 trial with long-term clinical outcomes for patients
treated with the OMNI® Surgical System technology (“OMNI”).
Publication is currently expected by December 31, 2023.
GEMINI 2, a prospective, multi-center,
medication washout trial designed to obtain 36-month follow-up for
patients treated in the original 12-month GEMINI trial, has been
completed. Favorable results demonstrate sustained and clinically
significant intraocular pressure (“IOP”) reduction of greater than
20% and clinically significant IOP lowering medication reduction at
36 months. The prospective 3-year clinical outcomes in the GEMINI 2
trial confirm and extend the previously published 12-month data
from the original GEMINI trial. GEMINI 2 included 66 patients
across eleven participating sites, and all patients underwent
medication wash-out at the two-year and three-year endpoints so
that the IOP-lowering effect of the OMNI procedure could be better
isolated and assessed.
The GEMINI study was the first prospective,
multi-center clinical trial to assess the safety and effectiveness
of OMNI procedures used in combination with cataract surgery in
patients with mild to moderate primary open-angle glaucoma
(“POAG”). GEMINI was designed to have eligibility criteria and
pre-planned endpoints similar to the pivotal Micro Invasive
Glaucoma Surgery (“MIGS”) trabecular bypass stent trials for
Hydrus® Microstent and iStent inject® following ANSI Z80.27
guidelines including medication washout pre-surgically and at the
endpoint. GEMINI was statistically powered and had a priori
hypotheses of superiority compared to the historical control group
(cataract surgery only) derived from the two stent studies.
In the original GEMINI study, at 12 months, OMNI
plus cataract surgery achieved a mean IOP reduction of 8.2 mmHg
(-34%). A post-hoc analysis of diurnal IOP fluctuations at one year
in the GEMINI study showed that after surgery with OMNI, IOP
fluctuations were significantly reduced compared to pre-surgical
measurements.
GEMINI 2 Clinical Outcomes:
- Through three years, data from the
GEMINI trial and GEMINI 2 study extension reported a 20% or more
reduction of IOP in patients on the same or reduced medication at
24 months (mean of 27% IOP reduction) and at 36 months (mean of 29%
IOP reduction).
- Sustained medication reductions at
24 and 36 months were also reported, with 77% of study patients
medication-free at two years and 74% of study patients
medication-free at three years post-procedure.
- The published 36-month long-term
follow-up data from the GEMINI 2 multi-center trial, along with the
published 2-year long-term follow-up data from the ROMEO 2
multi-center study, demonstrate that the beneficial reductions in
IOP and medication use observed at the 12-month timepoint with the
OMNI procedure were sustained for two and three years
post-operatively.
- The low rate (1.5% over three
years) of secondary surgical interventions observed over the study
period suggests that patients treated with the OMNI procedure are
unlikely to require more aggressive and invasive glaucoma surgery
for a meaningful period of time.
GEMINI 2 Data for OMNI* |
Mean IOP (mmHg) |
Percent Mean IOP Reduction |
Number of Medications |
Percent Patients Medication Free at Each Reported
Interval |
Baseline |
23.1 |
|
1.63 |
5% |
12 Months |
15.6 |
-32% |
0.30 |
80% |
24 Months |
16.7 |
-27% |
0.41 |
77% |
36 Months |
16.3 |
-29% |
0.30 |
74% |
*Data listed in the table is for the 66 patients at 11
investigational sites participating in GEMINI 2 |
Dr. Steve Sarkisian, a GEMINI 2 Investigator and
a recognized glaucoma expert on MIGS, stated that “the consistency
of the results observed across all published OMNI studies is
striking and consistent with the clinical outcomes I have seen in
my surgical glaucoma practice. The IOP effectiveness and medication
reductions observed in this study are highly consistent with the
existing and robust body of evidence of this technology. As a
surgeon, consistent, reliable effectiveness across a broad patient
population and an excellent safety profile are very important to me
in offering a surgical procedure to my patients.”
“OMNI provides surgeons with access to the
entire, 360-degree diseased trabeculocanalicular outflow pathway
through a single clear corneal incision, with the aim of addressing
all sources of outflow resistance residing in the trabecular
meshwork, Schlemm’s canal, and the distal collector channels. The
totality of the results from multiple peer-reviewed, published
studies demonstrates that the OMNI aqueous outflow restoration
procedure is safe and effective, as it delivers clinically
meaningful and durable reductions in both intraocular pressure and
medication use at both two and three years. This longer-term,
prospective, multi-center trial data further supports the need for
continued access to OMNI technology,” said Paul Badawi, co-founder
and CEO of Sight Sciences.
Authors and affiliations: Michael D. Greenwood
MD of Vance Thompson Vision, Arkadiy Yadgarov MD of Omni Eye
Services, Brian E. Flowers MD of Ophthalmology Associates, Steven
R. Sarkisian Jr. MD of Oklahoma Eye Surgeons, Jaime E. Dickerson
Jr., PhD of Sight Sciences and North Texas Health Science Center,
and Afua Ohene-Nyako of Sight Sciences.
Paper Reference: Greenwood MD et al. 36-Month
Outcomes from the Prospective GEMINI Study: Canaloplasty and
Trabeculotomy Combined with Cataract Surgery for Patients with
Primary Open-Angle Glaucoma. Clinical Ophthalmology.
About Sight SciencesSight
Sciences is an eyecare technology company focused on developing and
commercializing innovative solutions 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 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,
Inc.SION and TCOR are trademarks of Sight Sciences, Inc.Hydrus is a
registered trademark of Alcon Vision LLC.iStent inject is a
registered trademark of Glaukos Corporation. © 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, 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 anticipated timing for
publication of GEMINI 2 results and the continued need for access
to the OMNI technology. 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 contactpr@SightSciences.com
Investor contact:Philip TaylorGilmartin
Group415.937.5406Investor.Relations@Sightsciences.com
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