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Sight Sciences OMNI® Surgical System to Be Featured in Multiple Presentations at the 2022 European Society of Cataract and Refractive Surgery Annual Meeting

September 16, 2022

News

September 11, 2023
Sight Sciences Provides Revenue Guidance for the Third Quarter of 2023 and Updates Revenue Guidance for Full Year 2023
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September 11, 2023
Sight Sciences Appoints Matt Link as Chief Commercial Officer
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August 30, 2023
Sight Sciences to Present at the Upcoming Morgan Stanley 21st Annual Global Healthcare Conference
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August 04, 2023
Sight Sciences Reports Second Quarter 2023 Financial Results and Reaffirms Guidance for Full Year 2023
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July 21, 2023
Sight Sciences to Report Second Quarter 2023 Financial Results on August 3, 2023
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July 20, 2023
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
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June 21, 2023
Cigna Expands Coverage of Glaucoma Surgical Procedures to Include Canaloplasty and Goniotomy (Trabeculotomy)
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June 09, 2023
Sight Sciences Announces Addition of New Director Catherine Mazzacco
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Important Product Information for OMNI® Surgical System

OMNI® Surgical System IMPORTANT PRODUCT INFORMATION
Indications for Use

The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm’s canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.

Contraindications

Do not use the OMNI® in any situations where the iridocorneal angle is compromised or has been damaged (e.g., from trauma or surgery), since it may not be possible to visualize the angle or to properly pass the microcatheter.

Do not use the OMNI® in patients with angle recession; neovascular glaucoma; chronic angle closure; narrow-angle glaucoma; traumatic or malignant glaucoma; or narrow inlet canals with plateau iris.

Do not use the OMNI® Surgical System in quadrants with previous MIGS implants.

Please refer to the full Instructions for Use, available at omnisurgical.com, for warnings, precautions, and adverse event information.

Warnings

1. Do not use in cases where there is insufficient visibility to properly see the iridocorneal angle. The following conditions may prohibit sufficient visualization required for safe and successful cannula and microcatheter placement: corneal edema, corneal haze, corneal opacity, or any other conditions that may inhibit gonioscopic view of the iridocorneal angle and intended cannula entry location.

2. Perform gonioscopy prior to taking a patient to surgery to exclude congenital anomalies of the iridocorneal angle, anterior segment dysgeneses, peripheral anterior synechiae (PAS), rubeosis, and any other angle abnormalities that could lead to improper placement of the cannula and microcatheter and pose a hazard.

3. Maintain direct microscopic or gonioscopic visualization of the cannula tip and microcatheter tip at all times during the procedure to facilitate advancement and to avoid inadvertently damaging intraocular structures, kinking the microcatheter or unintended tearing of trabecular meshwork.

4. The surgeon should monitor the patient postoperatively for proper maintenance of intraocular pressure. If intraocular pressure is not adequately maintained after surgery, the surgeon should initiate appropriate management of intraocular pressure.

Potential adverse events

Adverse events that may be reasonably associated with the use of the OMNI® System in the eye include, but are not limited to, the following: anterior chamber shallowing, severe, prolonged, or persistent intraocular inflammation, endophthalmitis or other ocular infection, aqueous misdirection, Descemet’s membrane tear or detachment, intracorneal hematoma, choroidal effusion, suprachoroidal hemorrhage, corneal decompensation, corneal injury, corneal edema or opacification, unintended trabeculotomy, cyclodialysis cleft, hyphema, hypopyon, hypotony, hypotony maculopathy, IOL dislocation, cataract formation, iris injury, tear, or iridodialysis, loss of vitreous, perforation of sclera, posterior capsular bag rupture, proliferative vitreoretinopathy, pupillary block, pupillary membrane formation, retinal detachment, retinal dialysis, retinal flap tears, secondary surgical intervention, including, but not limited to, glaucoma surgery, and vitreous hemorrhage. Federal (USA) law restricts this device to sale, distribution, or use by or on the order of a physician.

Important Product Information

INDICATIONS FOR USE

The TearCare® System is intended 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.

CONTRAINDICATIONS

    • The TearCare® System is contraindicated for patients with:
    • Recent (i.e. within the last 90 days) surgical procedure to the eye or eyelid.
    • Recent ocular injury.
    • History of Herpes Simplex or Herpes Zoster of the eye or eyelid.
    • Active ocular or periocular infection, inflammation or irritation.
    • Diminished or abnormal facial, periocular, ocular, or corneal sensation.
    • Ocular surface ulcers.
    • Hordeolum, stye, or chalazion.
    • Do not use the TearCare® System in patients under the age of 22 years.
    • Pacemakers or implantable cardiac defibrillators (ICD). Use of the TearCare® System may affect the performance of pacemakers or ICD’s due to electromagnetic interference (EMI). To avoid any potentially serious safety effects, patients with these implants should not be treated with the TearCare® System.
    • Known allergy to acrylate.
    • Known allergy to silicone tissue adhesives.
    • Known allergy to copper.

    WARNINGS

    • Do not use the TearCare® System outside the instructions for use. Doing so can result in unanticipated patient harm.
    • Do not attempt to connect the SmartHub™ or SmartLid™ directly to an electrical outlet of any kind.
    • Do not use the TearCare® System in or near an MRI suite or near a magnetic field. Serious injury can occur to a patient or technician if a TearCare® System is brought into an MRI suite.
    • The TearCare® System has not been tested in the presence of flammable anesthetics or other flammable agents in combination with air, nitrous oxide, or oxygen enriched environments.
    • Do not apply SmartLids to non-intact skin (i.e., skin with active abrasion, cut, burn, rash, inflammation, redness, etc.)

    PRECAUTIONS

    • Use of the TearCare® System in patients with eyelid abnormalities (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis, etc.) may result in poor adhesion of the SmartLid™ to the eyelid and/or reduced benefit.
    • Use caution when using the TearCare® System in patients with ocular surface abnormalities (e.g. pterygium, pingueculum, corneal dystrophies, etc.) as the heat delivered by the System may aggravate these conditions.
    • Remove contact lenses from the patient’s eyes prior to use of the TearCare® System. Patients should wait 60 minutes after the completion of the TearCare® procedure before re-inserting contact lenses.
    • Do not apply the SmartLids™ to any other part of the patient’s body including the cornea. The SmartLids™ are only intended for application on the external surface of the patient’s eyelids.
    • It is important for patient to keep their eyes open (blinking is permitted) during treatment, to allow heat to dissipate off of the ocular surface.
    • Effectiveness of the TearCare®System has not been established in subjects for whom the treatment temperature is lowered from Warmth Level Setting #5 due to patient pain or discomfort.
    • Do not reuse the SmartLids™. Cross-contamination can occur if re-use is attempted.
    • Do not use a TearCare® System, its components, or accessories that appear damaged. Inspect all components for damage before each use.
    • The safety and effectiveness of the TearCare®System is not known in the following patient populations that were excluded in the OLYMPIA pivotal study: patients under 22 years of age, dry eye signs and symptoms other than meibomian gland dysfunction, severe signs and symptoms of dry eye due to meibomian gland dysfunction (OSDI > 79), mild signs and symptoms of dry eye due to meibomian gland dysfunction, and other study exclusions described in the TearCare®Instructions for Use.

    POTENTIAL ADVERSE EVENTS

    Potential adverse events associated with the use of the TearCare® System include the following:

    • Eyelid or eye pain requiring discontinuation of the treatment procedure
    • Eyelid irritation or inflammation*
    • Ocular surface irritation or inflammation*
    • Ocular symptoms (such as burning, redness, tearing, visual disturbance, redness)
    • Burn, erythema, or swelling of the eyelids
    • Conjunctival infection (moderate or severe)
    • Conjunctival abrasion
    • Corneal abrasion
    • Corneal deformation
    • Allergic or inflammatory reaction to medical adhesive on the SmartLid device
    • Formation of a chalazion or stye*
    • Decline in visual acuity*
    • Worsening of dry eye symptoms*
    • Increased discomfort or pain of ocular surface (grittiness, foreign body sensation, etc.)
    • Discomfort or pain of eyelids or orbit*
    • There is a potential risk of thermal injury to eye or eyelid based on the device design.
    Important Product Information for SION™ Surgical Instrument

    INDICATIONS FOR USE

    The SION™ Surgical Instrument is a sterile, single use, manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork.

    CONTRAINDICATIONS

    Do not use the SION™ if there is inadequate corneal clarity, or poor visualization of angle structures or in any situations where the anterior chamber angle has been damaged (i.e., from trauma or surgery) or it may not be possible to pass the device through Schlemm’s canal.

    SION™ is contraindicated in patients: with angle recession, neovascular glaucoma, chronic angle closure, narrow angle glaucoma, narrow inlets with plateau iris, peripheral anterior synechiae, traumatic, malignant, or uveitic glaucoma; it is also contraindicated in patients who have had previous argon laser trabeculoplasty, ab interno devices implanted in or through Schlemm’s Canal, or prior incisional glaucoma surgery including trabeculotomy, goniotomy.

    WARNINGS

    Always maintain direct microscopic and gonioscopic visualization of the instrument tip during the procedure to avoid inadvertently damaging intraocular structures. Avoid touching the SION™ tip to any surfaces as this may damage it. Do not use the SION™ tip to create a corneal incision.

    POTENTIAL ADVERSE EVENTS

    Adverse events that may be reasonably associated with the use of the instrument include but are not limited to the following: anterior chamber shallowing, prolonged, or persistent intraocular inflammation, aqueous misdirection, choroidal effusion, suprachoroidal hemorrhage, Descemet’s membrane tear or detachment, corneal decompensation, corneal injury, corneal edema or opacification, intracorneal hematoma, cyclodialysis cleft, damage to posterior wall of Schlemm’s canal, hyphema, hypopyon, hypotony, hypotonic maculopathy, IOL dislocation, iris injury, tear, or iridodialysis, loss of vitreous, perforation of sclera, posterior capsular bag rupture, posterior capsule opacification, proliferative vitreoretinopathy, pupillary block, pupillary membrane formation, retinal detachment, retinal dialysis, retinal tears, vitreous hemorrhage, elevated IOP requiring treatment and endophthalmitis.