Sight Sciences Announces the Publication of Large-Scale, Real-World MIGS Study Demonstrating the Comprehensive Aqueous Outflow Restorative Procedure with OMNI® Surgical System Technology is Effective at Lowering Both IOP and IOP Reducing Medications at 2
April 10 2024 - 3:05PM
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
results as published in the American Journal of Ophthalmology
(“AJO”) International of the large scale, comparative real-world
clinical outcomes study of patients treated by three leading,
minimally invasive glaucoma surgery (“MIGS”) technologies.
Using the American Academy of Ophthalmology
IRIS® Registry (Intelligent Research in Sight), the largest
specialty society clinical data registry in all of medicine and the
first comprehensive eye disease clinical registry in the United
States, this large-scale MIGS study evaluated long-term 2-year
post-surgical outcomes among patients with primary open-angle
glaucoma (“POAG”) treated with the three most commonly used
FDA-approved/cleared ab interno MIGS devices in the U.S. (OMNI
Surgical System (“OMNI”), Hydrus® Microstent, and iStent inject®)
combined with cataract surgery, as well as for cataract surgery
alone.
OMNI facilitates a unique implant-free, ab
interno procedure that comprehensively addresses the three primary
areas of resistance in the conventional outflow pathway. OMNI
technology has been cleared by the FDA for canaloplasty followed by
trabeculotomy to reduce intraocular pressure in adult patients with
primary open-angle glaucoma.
Baseline Patient
Characteristics:
- The entire study cohort consisted of 77,391 patients with
glaucoma and 109,745 glaucomatous eyes
- 6,632 patients and 9,000 eyes received a MIGS procedure in
combination with cataract surgery, and the remainder received
cataract surgery alone
- The four cohorts had generally similar baseline characteristics
in terms of intraocular pressure (“IOP”) and mean number of
IOP-lowering medications (see table below)
- The overall population was divided into two subgroups depending
on the baseline, pre-surgical lOP; > 18 mmHg and ≤ 18 mmHg. The
primary treatment goal for the high baseline IOP group (>
18mmHg) was IOP reduction, with a secondary goal to reduce
medication burden. The primary treatment goal for the low baseline
IOP group (< 18mmHg) was to reduce medication burden.
Baseline |
Group 1 Pre-op(> 18mmHg
IOP) |
Group 2 Pre-op(≤ 18mmHg IOP) |
|
Mean IOP(mmHg) |
Number ofIOP-LoweringMedicationClasses |
MeanIOP(mmHg) |
Number ofIOP-LoweringMedication Classes |
OMNI Surgical System |
22.5 |
1.95 |
14.1 |
2.01 |
Hydrus Microstent |
22.5 |
1.89 |
14.2 |
1.89 |
iStent inject |
22.2 |
1.58 |
14.4 |
1.58 |
Cataract-Surgery Alone |
22.8 |
1.60 |
14.5 |
1.62 |
Clinical Outcomes:
- At 24 months, high baseline IOP
(>18 mmHg) patients who received the outflow procedure using
OMNI technology had:
- the greatest numerical reduction in
IOP, and
- the greatest numerical reduction in
medication use
- At 24 months, low baseline IOP (≤18
mmHg) patients who received the outflow procedure using OMNI
technology had:
- the greatest numerical reduction in
IOP, and
- a statistically significantly
greater mean medication use reduction compared to all other
treatment groups
Post Treatment@ 24 Months |
Group 1 > 18mmHg IOPTreatment Goal: IOP
and Medication Reduction |
Group 2 ≤ 18mmHg IOPTreatment Goal:
Medication Reduction |
|
Mean Reduction in IOP mmHg (% Change From
Baseline) |
Mean Medication Class Reduction |
Mean Reduction in IOP mmHg (% Change From
Baseline) |
Mean Medication Class Reduction |
OMNI Surgical System |
-6.64 (30%) |
-1.34 |
-0.47 (3%) |
-1.42 |
Hydrus Microstent |
-5.71 (25%) |
-1.20 |
+0.03 (0%) |
-1.18 |
iStent inject |
-4.96 (22%) |
-0.86 |
-0.17 (1%) |
-0.95 |
Cataract-Surgery Alone |
-5.55 (24%) |
-0.67 |
-0.07 (0%) |
-0.65 |
“Consistent with our many prior published
studies, this large-scale, real-world MIGS dataset from the IRIS
Registry, as analyzed by Verana Health® and published in a top
peer-reviewed journal, corroborates that the OMNI procedure is
efficacious as it delivers clinically meaningful and durable
reductions in both intraocular pressure and medication use at two
years. OMNI technology was designed with the goal of restoring the
natural outflow process of the eye by addressing the three areas of
resistance associated with primary open-angle glaucoma. We are
excited to see that large-scale comparison studies of MIGS
standards-of-care continue to corroborate the robust IOP reduction
and medication reduction associated with the comprehensive OMNI
outflow procedure,” said Paul Badawi, co-founder and CEO of Sight
Sciences. “I’d also like to thank the team at Verana Health and the
American Academy of Ophthalmology for making critical, real-world,
large-scale, clinical outcome information in the IRIS Registry
available for all stakeholders, including eyecare providers,
payors, industry, and researchers.”
Authors and affiliations:
Michael Mbagwu (Stanford University School of Medicine, Palo Alto,
CA), Richard Chapman (Verana Health, San Francisco, CA), Kristian
Garcia Aesara, Chapel Hill, NC, Aesara, Chapel Hill, NC 3, Jaime E
Dickerson Jr (Sight Sciences, Menlo Park, CA, and North Texas Eye
Research Institute, University of North Texas Health Science
Center, Fort Worth, TX), and Louis B Cantor (Indiana University
School of Medicine, Department of Ophthalmology, Indianapolis,
IN).
Paper Reference: Michael
Mbagwu, Richard Chapman, Kristian Garcia, Cristina Masseria, Jaime
E Dickerson, Louis B Cantor, Ab Interno Minimally Invasive Glaucoma
Surgery Combined with Cataract Surgery and Cataract Surgery Alone:
IRIS® Registry Study, AJO International, 2024,100015, ISSN
2950-2535.
About Sight SciencesSight
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 (“POAG”); 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. Visit sightsciences.com for more
information.
About Verana Health
Verana Health® (“Verana”) is revolutionizing
patient care and clinical research by unlocking the potential of
real-world data. Verana has an exclusive real-world data network of
90 million de-identified patients from more than 20,000 clinicians,
stemming from its exclusive data partnerships with three leading
medical societies. Verana harnesses deep expertise, secure advanced
technology, and direct access to exclusive, near real-time data
sources to deliver actionable quality insights that help companies
make sense of the data. Visit veranahealth.com for more
information.
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.Hydrus is a registered trademark of Alcon Vision
LLC.iStent inject is a registered trademark of Glaukos Corporation.
IRIS is a registered trademark of the American Academy of
Ophthalmology.Verana Health is a registered trademark of Verana
Health. © 2024 Sight Sciences. All rights reserved. 04/2024
OM-3150-US.v1
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contact: pr@SightSciences.com
Investor contact:Philip TaylorGilmartin
Group415.937.5406Investor.Relations@SightSciences.com
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